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A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis (BREEZE-AD3)

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Baricitinib

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, atopic eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions:

Exclusion Criteria:

Had investigational product permanently discontinued at any time during a previous Baricitinib study.
Had temporary investigational product interruption continue at the final study visit of a previous Baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study

Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:

Inclusion Criteria:

Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
Agree to use emollients daily.

Exclusion Criteria:

Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
Have been treated with the following therapies:
- Monoclonal antibody for less than 5 half-lives prior to randomization.
- Received prior treatment with any oral Janus kinase (JAK) inhibitor.
- Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
- Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
Have had major surgery within the past eight weeks or are planning major surgery during the study.
Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
Have specific laboratory abnormalities.
Have received certain treatments that are contraindicated.
Pregnant or breastfeeding.

Sites / Locations

CEDIC-Centro de Investigaciones Clinicas
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires Skin
Fundacion CIDEA
Instituto de Neumonología y Dermatología
Psoriahue Medicina Interdisciplinaria
Parra Dermatología
Woden Dermatology
Skin & Cancer Foundation Australia
The Skin Centre
Veracity Clinical Research Pty Ltd
Clinical Trials SA Pty Ltd
Skin and Cancer Foundation Inc.
Fremantle Dermatology
Ordensklinikum Linz GmbH - Elisabethinen
Universitätsklinikum Graz
KA Rudolfstiftung
AKH
KH Hietzing mit neurologischem Zentrum Rosenhügel
Sozialmed. Zentrum Ost - Donauspital
Clintrial, s.r.o.
Fakultni nemocnice Kralovske Vinohrady
Fakultni Nemocnice v Motole
Nemocnice Na Bulovce
Fakultni Nemocnice U svate Anny
Nemocnice Novy Jicin a.s.
Fakultni Nemocnice Plzen
Kozni ambulance Kutna Hora, s.r.o.
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Gentofte Hospital
Aarhus Universitehospital Marselisborg Centret
Hopital Saint-Louis
CHU de Bordeaux Hopital Saint Andre
CHU Grenoble Alpes
Chru De Nantes Hotel-Dieu
CHU de Nice Hopital de L'Archet
Centre Hospitalier Lyon Sud
Hopital Larrey
Universitätsklinikum Freiburg
Universitätsklinikum Heidelberg
Klinikum der Universität München
Gemeinschaftspraxis Mahlow
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Universitätsmedizin Rostock
Dermatologisches Zentrum Osnabrück Nord
Universitätsmedizin Göttingen
Universitaetsklinikum Essen
Universitätsklinikum Otto-von-Guericke-Universität
Praxis Gerlach
Universitätsklinikum Carl Gustav Carus
Universität Leipzig - Universitätsklinikum
Universitätsklinikum Schleswig-Holstein
Universitätsklinikum Schleswig-Holstein
Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik
Charité Universitätsmedizin Berlin
Rothhaar Studien GmbH
ISA GmbH
Praxis für Ganzheitliche Dermatologie im Ärztehaus
TFS Trial Form Support GmbH
Oroshaza Varosi Onkormanyzat Korhaza
SZTE AOK Borgyogyaszati es Allergologiai Klinika
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Trial Pharma Kft.
Allergo-Derm Bakos Kft
Kaposi Mor Oktato Korhaz
Markusovszky Korhaz
UNO Medical Trials Kft.
MedMare Bt
King George Hospital
All India Institue of Medical Sciences (AIIMS)
Sir Ganga Ram Hospital
Panchshil Hospital
Byramjee Jeejeebhoy Medical College & Civil Hospital
Dr. D. Y. Patil Medical College & Hospital
Seth GS Medical College & KEM Hospital
Gandhi Hospital
Haemek Medical Center- Dermatology
Rambam Medical Center
Hadassah Medical Center
Rabin Medical Center
Sheba Medical Center
Tel Aviv Sourasky Medical Center
Policlinico Univ. Agostino Gemelli
Istituto Clinico Humanitas
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
Azienda Ospedaliera Universitaria Federico II
Azienda Ospedaliera - Universitaria Pisana
Policlinico di Tor Vergata
Ospedale Policlinico Giambattista Rossi, Borgo Roma
ULSS 8
Yanagihara dermatology clinic
Kawashima Dermatology Clinic
Medical Corporation Soleil Miyata Dermatology Clinic
Fumimori Clinic
Kurume University Hospital
Hiroshima University Hospital
Shibaki Dermatology Clinic
Sapporo Skin Clinic
Tokyo Medical University Ibaraki Medical Center
Queen's Square Dermatology and Allergology
Nomura Dermatology Clinic
Yokohama City Minato Red Cross Hospital
Noguchi Dermatology
Kyoto Prefectural University of Medicine
Osaka Habikino Medical Center
Yoshioka Dermatology Clinic
Kume Clinic
Senri-Chuo Hanafusa Dermatology Clinic
Sanrui Dermatology Clinic
Shimane University Hospital
JA Shizuoka Kohseiren Enshu Hospital
Jichi Medical University Hospital
Iidabashi Clinic
Tokyo Teishin Hospital
Nihonbashi Sakura Clinic
Hosono Clinic
Sumire Dermatology Clinic
Oizumi Hanawa Clinic
Naoko Dermatology Clinic
NTT Medical Center Tokyo
Yamate Dermatological Clinic
Tachikawa Dermatology Clinic
Shirasaki Clinic
Yamanashi Prefectural Central Hospital
Gifu University Hospital
Osaka City University Hospital
Ajou University Hospital
Korea University Ansan Hospital
Dongguk University Ilsan Hospital
Gachon University Gil Medical Center
Severance Hospital Yonsei University Health System
Konkuk University Medical Center
Seoul St. Mary's Hospital
Chungang University Hospital
Hallym University Kangnam Sacred Heart Hospital
Hospital de Jesus I.A.P.
Grupo Medico Camino S.C.
Clinica De Enfermedades Cronicas y Procedimientos Especiales
CRI Centro Regiomontano de Investigacion S.C.
Hospital Universitario Dr. Jose Eleuterio Gonzalez
JM Research S.C.
RM Pharma Specialists S.A. de C.V.
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
DermoDent, Centrum Medyczne Czajkowscy
Dermed Centrum Medyczne Sp. z o.o.
Lubelskie Centrum Diagnostyczne
Barbara Rewerska DIAMOND CLINIC
Wojskowy Instytut Medyczny CSK MON
Centrum Medyczne AMED
Centralny Szpital Kliniczny MSWiA
Centrum Medyczne Evimed
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Centrum Badan Klinicznych, PI House
Centrum Medyczne Angelius Provita
Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii
LASER CLINIC Specjalistyczne Gabinety Lekarskie
GBUZ Clinical dermatology and venereological dispensary
State scientific centre for dermatovenerology and cosmetolog
Russian state medical-stomatological university n.a. Evdokimov
LLC ArsVitae NorthWest
LLC Medical Center "Kurator"
SPb SBHI Skin-venerologic dispensary #10
Hospital Germans Trias i Pujol
Hospital Universitario Rey Juan Carlos
Clinica Universitaria De Navarra
Hospital General Universitario Alicante
Hospital del Mar
Hospital De Gran Canaria Dr. Negrin
Hospital Infanta Leonor
Hospital Universitario Ramon y Cajal
Hospital Universitario 12 de Octubre
Hospital Universitario La Paz
Centro de Especialidades Mollabao
CHUV Centre Hospitalier Universitaire Vaudois
Inselspital Bern
HUG-Hôpitaux Universitaires de Genève
Universitätsspital Zürich
Chang Gung Memorial Hospital - Kaohsiung
Taipei Medical University- Shuang Ho Hospital
Chung Shan Medical University Hospital
National Cheng Kung University Hospital
National Taiwan University Hospital
Chang Gung Memorial Hospital - Taipei
Chang Gung Memorial Hospital - Linkou

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Responders and Partial Responders (RPR)-Placebo

RPR-Bari 1-milligram (mg)

RPR-Bari 2-mg

RPR-Bari 4-mg

Non-responders (NR): Bari 1 mg to 2 mg

NR: Bari 1 mg to 4 mg

NR: Bari 2 mg to 2 mg

NR: Bari 2 mg to 4 mg

NR: Bari 4 mg to 4 mg

NR: Placebo to Bari 2 mg

NR: Placebo to Bari 4 mg

Placebo

Bari 1 mg

Bari 2 mg

Bari 4 mg

Bari 2-mg Open-Label Addendum

Arm Description

Responders or partial responders (RPR) [Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.

Non-responder (NR) [those not meeting definition of RPR] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.

Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

Outcomes

Primary Outcome Measures

Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

Secondary Outcome Measures

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Full Information

NCT ID

NCT03334435

First Posted

November 3, 2017

Last Updated

July 14, 2023

Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03334435

Brief Title

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

Acronym

BREEZE-AD3

Official Title

A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

March 28, 2018 (Actual)

Primary Completion Date

September 21, 2020 (Actual)

Study Completion Date

July 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

eczema, atopic eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1645 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Responders and Partial Responders (RPR)-Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

RPR-Bari 1-milligram (mg)

Arm Type

Experimental

Arm Description

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.

Arm Title

RPR-Bari 2-mg

Arm Type

Experimental

Arm Description

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.

Arm Title

RPR-Bari 4-mg

Arm Type

Experimental

Arm Description

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.

Arm Title

Non-responders (NR): Bari 1 mg to 2 mg

Arm Type

Experimental

Arm Description

Arm Title

NR: Bari 1 mg to 4 mg

Arm Type

Experimental

Arm Description

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

Arm Title

NR: Bari 2 mg to 2 mg

Arm Type

Experimental

Arm Description

Arm Title

NR: Bari 2 mg to 4 mg

Arm Type

Experimental

Arm Description

Arm Title

NR: Bari 4 mg to 4 mg

Arm Type

Experimental

Arm Description

Arm Title

NR: Placebo to Bari 2 mg

Arm Type

Experimental

Arm Description

Arm Title

NR: Placebo to Bari 4 mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

Arm Title

Bari 1 mg

Arm Type

Experimental

Arm Description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

Arm Title

Bari 2 mg

Arm Type

Experimental

Arm Description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

Arm Title

Bari 4 mg

Arm Type

Experimental

Arm Description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.

Arm Title

Bari 2-mg Open-Label Addendum

Arm Type

Experimental

Arm Description

Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

Intervention Type

Drug

Intervention Name(s)

Baricitinib

Other Intervention Name(s)

LY3009104

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1

Description

Time Frame

Weeks 16, 36 and 52

Title

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

Time Frame

Weeks 16, 36, and 52

Secondary Outcome Measure Information:

Title

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

Time Frame

Weeks 16, 36, and 52

Title

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

Time Frame

Weeks 16, 36, and 52

Title

Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

Time Frame

Weeks 16, 36 and 52

Title

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

Time Frame

Weeks 16, 36, and 52

Title

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

Time Frame

Weeks 16, 36, 52

Title

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

Time Frame

Weeks 16, 36, and 52

Title

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75

Description

Time Frame

Weeks 16, 36, and 52 Weeks

Title

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Description

Time Frame

Weeks 16, 36, and 52

Title

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

Description

Time Frame

Weeks 16, 36, and 52

Title

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Description

Time Frame

Weeks 16, 36, and 52

Title

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)

Description

Time Frame

Week 16

Title

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Description

Time Frame

Week 16

Title

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

Description

Time Frame

Week 16

Title

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Description

Time Frame

Week 16

Title

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

Time Frame

Weeks 4, 16, 24, 52

Title

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.

Time Frame

Weeks 4, 16, 24, 52

Title

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

Time Frame

Weeks 4, 16, 24, 52

Title

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.

Time Frame

Weeks 4, 16, 24, 52

Title

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

Description

Time Frame

Weeks 4, 16, 24, 52

Title

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Description

Time Frame

Weeks 4, 16, 24, 52

Title

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

Description

Time Frame

Week 16

Title

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Description

Time Frame

Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions: Exclusion Criteria: Had investigational product permanently discontinued at any time during a previous Baricitinib study. Had temporary investigational product interruption continue at the final study visit of a previous Baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study OR Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria: Inclusion Criteria: Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months. Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening. Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). Agree to use emollients daily. Exclusion Criteria: Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections. A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past. Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma). Have been treated with the following therapies: Monoclonal antibody for less than 5 half-lives prior to randomization. Received prior treatment with any oral Janus kinase (JAK) inhibitor. Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study. Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization. Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg. Have had major surgery within the past eight weeks or are planning major surgery during the study. Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure. Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator. Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness. Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis. Have specific laboratory abnormalities. Have received certain treatments that are contraindicated. Pregnant or breastfeeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

CEDIC-Centro de Investigaciones Clinicas

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425DES

Country

Argentina

Facility Name

Centro de Investigaciones Metabólicas (CINME)

City

Buenos Aires

ZIP/Postal Code

C1027AAP

Country

Argentina

Facility Name

Buenos Aires Skin

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1055AA0

Country

Argentina

Facility Name

Fundacion CIDEA

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1121ABE

Country

Argentina

Facility Name

Instituto de Neumonología y Dermatología

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1425BEA

Country

Argentina

Facility Name

Psoriahue Medicina Interdisciplinaria

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1425DKG

Country

Argentina

Facility Name

Parra Dermatología

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Woden Dermatology

City

Phillip

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

Skin & Cancer Foundation Australia

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

The Skin Centre

City

Benowa

State/Province

Queensland

ZIP/Postal Code

4217

Country

Australia

Facility Name

Veracity Clinical Research Pty Ltd

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Clinical Trials SA Pty Ltd

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5073

Country

Australia

Facility Name

Skin and Cancer Foundation Inc.

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Fremantle Dermatology

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

Ordensklinikum Linz GmbH - Elisabethinen

City

Linz

State/Province

Oberösterreich

ZIP/Postal Code

4020

Country

Austria

Facility Name

Universitätsklinikum Graz

City

Graz

State/Province

Steiermark

ZIP/Postal Code

8036

Country

Austria

Facility Name

KA Rudolfstiftung

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

AKH

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

KH Hietzing mit neurologischem Zentrum Rosenhügel

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Sozialmed. Zentrum Ost - Donauspital

City

Wien

ZIP/Postal Code

1220

Country

Austria

Facility Name

Clintrial, s.r.o.

City

Praha 10

State/Province

Hl. M. Praha

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Fakultni nemocnice Kralovske Vinohrady

City

Praha 10

State/Province

Hl. M. Praha

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Fakultni Nemocnice v Motole

City

Praha 5

State/Province

Hl. M. Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Nemocnice Na Bulovce

City

Praha 8

State/Province

Hl. M. Praha

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Fakultni Nemocnice U svate Anny

City

Brno

State/Province

Jihomoravský Kraj

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Nemocnice Novy Jicin a.s.

City

Novy Jicin

State/Province

Moravskoslezsky Kraj

ZIP/Postal Code

741 01

Country

Czechia

Facility Name

Fakultni Nemocnice Plzen

City

Plzen-Bory

State/Province

Plzeňský Kraj

ZIP/Postal Code

305 99

Country

Czechia

Facility Name

Kozni ambulance Kutna Hora, s.r.o.

City

Kutna Hora

State/Province

Středočeský Kraj

ZIP/Postal Code

28401

Country

Czechia

Facility Name

Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

City

Usti nad Labem

State/Province

Ustecký Kraj

ZIP/Postal Code

40113

Country

Czechia

Facility Name

Gentofte Hospital

City

Hellerup

State/Province

Region Hovedstaden

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Aarhus Universitehospital Marselisborg Centret

City

Aarhus

State/Province

Region Midtjyland

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Hopital Saint-Louis

City

Paris

State/Province

Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

CHU de Bordeaux Hopital Saint Andre

City

Bordeaux Cedex

ZIP/Postal Code

33075

Country

France

Facility Name

CHU Grenoble Alpes

City

Grenoble Cédex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Chru De Nantes Hotel-Dieu

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

CHU de Nice Hopital de L'Archet

City

Nice cedex 3

ZIP/Postal Code

06202

Country

France

Facility Name

Centre Hospitalier Lyon Sud

City

Pierre Benite Cedex

ZIP/Postal Code

69495

Country

France

Facility Name

Hopital Larrey

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Universitätsklinikum Freiburg

City

Freiburg im Breisgau

State/Province

Baden-Württemberg

ZIP/Postal Code

79104

Country

Germany

Facility Name

Universitätsklinikum Heidelberg

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Klinikum der Universität München

City

München

State/Province

Bayern

ZIP/Postal Code

80337

Country

Germany

Facility Name

Gemeinschaftspraxis Mahlow

City

Blankenfelde-Mahlow

State/Province

Brandenburg

ZIP/Postal Code

15831

Country

Germany

Facility Name

Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

City

Darmstadt

State/Province

Hessen

ZIP/Postal Code

64283

Country

Germany

Facility Name

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitätsmedizin Rostock

City

Rostock

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

18057

Country

Germany

Facility Name

Dermatologisches Zentrum Osnabrück Nord

City

Bramsche

State/Province

Niedersachsen

ZIP/Postal Code

49565

Country

Germany

Facility Name

Universitätsmedizin Göttingen

City

Göttingen

State/Province

Niedersachsen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Universitaetsklinikum Essen

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Universitätsklinikum Otto-von-Guericke-Universität

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39120

Country

Germany

Facility Name

Praxis Gerlach

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01097

Country

Germany

Facility Name

Universitätsklinikum Carl Gustav Carus

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universität Leipzig - Universitätsklinikum

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Universitätsklinikum Schleswig-Holstein

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Universitätsklinikum Schleswig-Holstein

City

Lübeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Charité Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Rothhaar Studien GmbH

City

Berlin

ZIP/Postal Code

10783

Country

Germany

Facility Name

ISA GmbH

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Praxis für Ganzheitliche Dermatologie im Ärztehaus

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

TFS Trial Form Support GmbH

City

Hamburg

ZIP/Postal Code

20537

Country

Germany

Facility Name

Oroshaza Varosi Onkormanyzat Korhaza

City

Oroshaza

State/Province

Bekes

ZIP/Postal Code

5900

Country

Hungary

Facility Name

SZTE AOK Borgyogyaszati es Allergologiai Klinika

City

Szeged

State/Province

Csongrad

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

City

Debrecen

State/Province

Hajdu-Bihar

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Trial Pharma Kft.

City

Puspokladany

State/Province

Hajdu-Bihar

ZIP/Postal Code

4150

Country

Hungary

Facility Name

Allergo-Derm Bakos Kft

City

Szolnok

State/Province

Jasz-Nagykun-Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Kaposi Mor Oktato Korhaz

City

Kaposvar

State/Province

Somogy

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Markusovszky Korhaz

City

Szombathely

State/Province

Vas

ZIP/Postal Code

9700

Country

Hungary

Facility Name

UNO Medical Trials Kft.

City

Budapest

ZIP/Postal Code

1135

Country

Hungary

Facility Name

MedMare Bt

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

King George Hospital

City

Vizag

State/Province

Andhra Pradesh

ZIP/Postal Code

530002

Country

India

Facility Name

All India Institue of Medical Sciences (AIIMS)

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 029

Country

India

Facility Name

Sir Ganga Ram Hospital

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110060

Country

India

Facility Name

Panchshil Hospital

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380005

Country

India

Facility Name

Byramjee Jeejeebhoy Medical College & Civil Hospital

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380016

Country

India

Facility Name

Dr. D. Y. Patil Medical College & Hospital

City

Navi Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400706

Country

India

Facility Name

Seth GS Medical College & KEM Hospital

City

Mumbai

State/Province

Maharshtra

ZIP/Postal Code

400012

Country

India

Facility Name

Gandhi Hospital

City

Secunderabad

State/Province

Telangana

ZIP/Postal Code

500003

Country

India

Facility Name

Haemek Medical Center- Dermatology

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Rambam Medical Center

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

91220

Country

Israel

Facility Name

Rabin Medical Center

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Sheba Medical Center

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Tel Aviv Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Policlinico Univ. Agostino Gemelli

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Istituto Clinico Humanitas

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Federico II

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Azienda Ospedaliera - Universitaria Pisana

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Policlinico di Tor Vergata

City

Roma

ZIP/Postal Code

00133

Country

Italy

Facility Name

Ospedale Policlinico Giambattista Rossi, Borgo Roma

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

ULSS 8

City

Vicenza

ZIP/Postal Code

36100

Country

Italy

Facility Name

Yanagihara dermatology clinic

City

Ainokawa, Ichikawa-shi

State/Province

Chiba

ZIP/Postal Code

272-0143

Country

Japan

Facility Name

Kawashima Dermatology Clinic

City

Ichikawa-shi

State/Province

Chiba

ZIP/Postal Code

272-0033

Country

Japan

Facility Name

Medical Corporation Soleil Miyata Dermatology Clinic

City

Matsudo-shi

State/Province

Chiba

ZIP/Postal Code

271-0092

Country

Japan

Facility Name

Fumimori Clinic

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

815-0082

Country

Japan

Facility Name

Kurume University Hospital

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830 0011

Country

Japan

Facility Name

Hiroshima University Hospital

City

Hiroshima-shi

State/Province

Hiroshima-ken

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Shibaki Dermatology Clinic

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

006 0022

Country

Japan

Facility Name

Sapporo Skin Clinic

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-0063

Country

Japan

Facility Name

Tokyo Medical University Ibaraki Medical Center

City

Inashiki-gun

State/Province

Ibaraki

ZIP/Postal Code

300-0395

Country

Japan

Facility Name

Queen's Square Dermatology and Allergology

City

Nishi-ku, Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

220-6208

Country

Japan

Facility Name

Nomura Dermatology Clinic

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

221-0825

Country

Japan

Facility Name

Yokohama City Minato Red Cross Hospital

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Noguchi Dermatology

City

Kashima-machi, Kamimashiki-gun

State/Province

Kumamoto

ZIP/Postal Code

861-3101

Country

Japan

Facility Name

Kyoto Prefectural University of Medicine

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Osaka Habikino Medical Center

City

Habikino

State/Province

Osaka

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

Yoshioka Dermatology Clinic

City

Neyagawa-shi

State/Province

Osaka

ZIP/Postal Code

572-0838

Country

Japan

Facility Name

Kume Clinic

City

Nishi-ku Sakai-shi

State/Province

Osaka

ZIP/Postal Code

593-8324

Country

Japan

Facility Name

Senri-Chuo Hanafusa Dermatology Clinic

City

Toyonaka-shi

State/Province

Osaka

ZIP/Postal Code

560-0085

Country

Japan

Facility Name

Sanrui Dermatology Clinic

City

Ohmiya-ku,Saitama-shi

State/Province

Saitama

ZIP/Postal Code

330-0854

Country

Japan

Facility Name

Shimane University Hospital

City

Izumo

State/Province

Shimane

ZIP/Postal Code

693-8501

Country

Japan

Facility Name

JA Shizuoka Kohseiren Enshu Hospital

City

Hamamatsu-shi

State/Province

Shizuoka

ZIP/Postal Code

430-0929

Country

Japan

Facility Name

Jichi Medical University Hospital

City

Shimotsuke

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Iidabashi Clinic

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

102-0072

Country

Japan

Facility Name

Tokyo Teishin Hospital

City

Chiyoda-Ku

State/Province

Tokyo

ZIP/Postal Code

102-8798

Country

Japan

Facility Name

Nihonbashi Sakura Clinic

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0025

Country

Japan

Facility Name

Hosono Clinic

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Sumire Dermatology Clinic

City

Edogawa-ku

State/Province

Tokyo

ZIP/Postal Code

133-0057

Country

Japan

Facility Name

Oizumi Hanawa Clinic

City

Nerima-ku

State/Province

Tokyo

ZIP/Postal Code

178-0063

Country

Japan

Facility Name

Naoko Dermatology Clinic

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

NTT Medical Center Tokyo

City

Shinagawa-KU

State/Province

Tokyo

ZIP/Postal Code

141-8625

Country

Japan

Facility Name

Yamate Dermatological Clinic

City

Shinjuku

State/Province

Tokyo

ZIP/Postal Code

169-0075

Country

Japan

Facility Name

Tachikawa Dermatology Clinic

City

Tachikawa-shi

State/Province

Tokyo

ZIP/Postal Code

190-0023

Country

Japan

Facility Name

Shirasaki Clinic

City

Takaoka-shi

State/Province

Toyama

ZIP/Postal Code

9330871

Country

Japan

Facility Name

Yamanashi Prefectural Central Hospital

City

Kofu

State/Province

Yamanashi

ZIP/Postal Code

400-8506

Country

Japan

Facility Name

Gifu University Hospital

City

Gifu

ZIP/Postal Code

501-1194

Country

Japan

Facility Name

Osaka City University Hospital

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Ajou University Hospital

City

Suwon

State/Province

Gyeonggi Do

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Korea University Ansan Hospital

City

Ansan-si

State/Province

Gyeonggi-do

ZIP/Postal Code

15355

Country

Korea, Republic of

Facility Name

Dongguk University Ilsan Hospital

City

Goyang

State/Province

Gyeonggi-do

ZIP/Postal Code

10326

Country

Korea, Republic of

Facility Name

Gachon University Gil Medical Center

City

Incheon

State/Province

Korea

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Severance Hospital Yonsei University Health System

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Chungang University Hospital

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

Facility Name

Hallym University Kangnam Sacred Heart Hospital

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Hospital de Jesus I.A.P.

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06090

Country

Mexico

Facility Name

Grupo Medico Camino S.C.

City

México City

State/Province

Distrito Federal

ZIP/Postal Code

03310

Country

Mexico

Facility Name

Clinica De Enfermedades Cronicas y Procedimientos Especiales

City

Morelia

State/Province

Michoacan Morelia

ZIP/Postal Code

CP 58249

Country

Mexico

Facility Name

CRI Centro Regiomontano de Investigacion S.C.

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64060

Country

Mexico

Facility Name

Hospital Universitario Dr. Jose Eleuterio Gonzalez

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

JM Research S.C.

City

Cuernavaca

ZIP/Postal Code

62290

Country

Mexico

Facility Name

RM Pharma Specialists S.A. de C.V.

City

Distrito Federal

ZIP/Postal Code

3100

Country

Mexico

Facility Name

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

DermoDent, Centrum Medyczne Czajkowscy

City

Osielsko

State/Province

Kujawsko-pomorskie

ZIP/Postal Code

86-031

Country

Poland

Facility Name

Dermed Centrum Medyczne Sp. z o.o.

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Lubelskie Centrum Diagnostyczne

City

Swidnik

State/Province

Lubelskie

ZIP/Postal Code

21-040

Country

Poland

Facility Name

Barbara Rewerska DIAMOND CLINIC

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

31-559

Country

Poland

Facility Name

Wojskowy Instytut Medyczny CSK MON

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Centrum Medyczne AMED

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

01-518

Country

Poland

Facility Name

Centralny Szpital Kliniczny MSWiA

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Centrum Medyczne Evimed

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-625

Country

Poland

Facility Name

NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

City

Bialystok

State/Province

Podlaskie

ZIP/Postal Code

15-375

Country

Poland

Facility Name

Centrum Badan Klinicznych, PI House

City

Gdansk

State/Province

Pomorskie

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Centrum Medyczne Angelius Provita

City

Katowice

State/Province

Slaskie

ZIP/Postal Code

40-611

Country

Poland

Facility Name

Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

City

Olsztyn

State/Province

Warminsko-mazurskie

ZIP/Postal Code

10-229

Country

Poland

Facility Name

LASER CLINIC Specjalistyczne Gabinety Lekarskie

City

Szczecin

State/Province

Zachodniopomorskie

ZIP/Postal Code

70-332

Country

Poland

Facility Name

GBUZ Clinical dermatology and venereological dispensary

City

Krasnodar

State/Province

Krasnodarskiy Kray

ZIP/Postal Code

350020

Country

Russian Federation

Facility Name

State scientific centre for dermatovenerology and cosmetolog

City

Moscow

ZIP/Postal Code

107076

Country

Russian Federation

Facility Name

Russian state medical-stomatological university n.a. Evdokimov

City

Moscow

ZIP/Postal Code

111398

Country

Russian Federation

Facility Name

LLC ArsVitae NorthWest

City

Saint-Petersburg

ZIP/Postal Code

194223

Country

Russian Federation

Facility Name

LLC Medical Center "Kurator"

City

Saint-Petersburg

ZIP/Postal Code

196240

Country

Russian Federation

Facility Name

SPb SBHI Skin-venerologic dispensary #10

City

St. Petersburg

ZIP/Postal Code

194021

Country

Russian Federation

Facility Name

Hospital Germans Trias i Pujol

City

Barcelona

State/Province

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Universitario Rey Juan Carlos

City

Mostoles

State/Province

Madrid

ZIP/Postal Code

28933

Country

Spain

Facility Name

Clinica Universitaria De Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital General Universitario Alicante

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital De Gran Canaria Dr. Negrin

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35010

Country

Spain

Facility Name

Hospital Infanta Leonor

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Hospital Universitario Ramon y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Centro de Especialidades Mollabao

City

Pontevedra

ZIP/Postal Code

36001

Country

Spain

Facility Name

CHUV Centre Hospitalier Universitaire Vaudois

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Inselspital Bern

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

HUG-Hôpitaux Universitaires de Genève

City

Genève

ZIP/Postal Code

1205

Country

Switzerland

Facility Name

Universitätsspital Zürich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Chang Gung Memorial Hospital - Kaohsiung

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Taipei Medical University- Shuang Ho Hospital

City

New Taipei City

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung City

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei City

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Taipei

City

Taipei City

ZIP/Postal Code

10508

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Linkou

City

Taoyuan, (r.o.c.)

ZIP/Postal Code

33342

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Citations:

PubMed Identifier

36255569

Citation

Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.

Results Reference

derived

PubMed Identifier

33978711

Citation

Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, Kabashima K, DeLozier AM, Sun L, Cardillo T, Nunes FP, Reich K. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. doi: 10.1001/jamadermatol.2021.1273.

Results Reference

derived

PubMed Identifier

33826132

Citation

King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

Results Reference

derived

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/64kocErmNim2YSiiqCaOk6

Description

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis (Eczema) (BREEZE-AD3)

Learn more about this trial

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

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