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A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis (BREEZE-AD1)

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

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

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.
Aarhus Universitehospital Marselisborg Centret
Hopital Saint-Louis
CHU de Bordeaux Hopital Saint Andre
CHRU de Brest - Hôpital Morvan
CHU Grenoble Alpes
Chru De Nantes Hotel-Dieu
CHU de Nice Hopital de L'Archet
Centre Hospitalier Lyon Sud
Hopital Larrey
Universitätsklinikum Freiburg
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
Universitätsklinikum Bonn
Praxis Dr. Thomas Dirschka
Universitätsklinikum Otto-von-Guericke-Universität
Praxis Gerlach
Universitätsklinikum Carl Gustav Carus
Universität Leipzig - Universitätsklinikum
Hautarztzentrum Kiel
Universitätsklinikum Schleswig-Holstein
Universitätsklinikum Schleswig-Holstein
Rothhaar Studien GmbH
ISA GmbH
Praxis für Ganzheitliche Dermatologie im Ärztehaus
TFS Trial Form Support GmbH
King George Hospital
All India Institue of Medical Sciences (AIIMS)
Sir Ganga Ram Hospital
Panchshil Hospital
Byramjee Jeejeebhoy Medical College & Civil Hospital
M S Ramaiah Medical College Hospital
Dr. D. Y. Patil Medical College & Hospital
Jehangir Hospital
Seth GS Medical College & KEM Hospital
Chennai Meenakshi Multispeciality Hospital
Gandhi Hospital
MV Hospital and Research Centre
Istituto Clinico Humanitas
Azienda Ospedaliera Universitaria Federico II
Azienda Ospedaliera - Universitaria Pisana
Policlinico di Tor Vergata
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Kawashima Dermatology Clinic
Fumimori Clinic
Hiroshima University Hospital
Queen's Square Dermatology and Allergology
Yokohama City Minato Red Cross Hospital
Kyoto Prefectural University of Medicine
Kume Clinic
Shimane University Hospital
JA Shizuoka Kohseiren Enshu Hospital
Iidabashi Clinic
Nihonbashi Sakura Clinic
Sumire Dermatology Clinic
NTT Medical Center Tokyo
Shirasaki Clinic
Yamanashi Prefectural Central Hospital
Fukuoka University Hospital
Hospital de Jesus I.A.P.
Grupo Médico CAMINO S.C.
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
CRI Centro Regiomontano de Investigacion S.C.
Hospital Univ. 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
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
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 Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

4 milligram (mg) Baricitinib

2 mg Baricitinib

1 mg Baricitinib

Placebo

4 mg Baricitinib Maximum Extended Enrollment Cohort

2 mg Baricitinib Maximum Extended Enrollment Cohort

1 mg Baricitinib Maximum Extended Enrollment Cohort

Placebo Maximum Extended Enrollment Cohort

Arm Description

4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match.

2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.

1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.

Placebo administered orally once daily.

4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.

2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.

1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.

Placebo administered orally once daily.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib)

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.

Secondary Outcome Measures

Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib)

The IGA measures the investigator's global assessment of the participant's overall severity of their 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.

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

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.

Percentage of Participants Achieving EASI90

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 EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.

Percent Change From Baseline in EASI Score

The EASI assesses objective physician estimates of 2 dimensions of AD - 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). Least Square (LS) Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effect

Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.

Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)

The Itch Numeric Rating Scale (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.

Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)

Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times,where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.

Change From Baseline in the Skin Pain Numeric Rating Scale (NRS)

Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Percentage of Participants Achieving EASI50

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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and 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 EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.

Percentage of Participants Achieving IGA of 0

Change From Baseline in SCORAD

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Percentage of Participants Achieving SCORAD90

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.

Change From Baseline in Body Surface Area (BSA) Affected

Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

Percentage of participants developing skin infections requiring antibiotic treatment.

Percent Change From Baseline in Itch NRS

The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)

The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score

The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, i.e., "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)

The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline in the Dermatology Life Quality Index (DLQI)

The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire

The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm

EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)

EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement

Full Information

NCT ID

NCT03334396

First Posted

November 3, 2017

Last Updated

August 7, 2020

Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03334396

Brief Title

A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

Acronym

BREEZE-AD1

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 23, 2017 (Actual)

Primary Completion Date

December 6, 2018 (Actual)

Study Completion Date

August 16, 2019 (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 efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

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

660 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4 milligram (mg) Baricitinib

Arm Type

Experimental

Arm Description

4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match.

Arm Title

2 mg Baricitinib

Arm Type

Experimental

Arm Description

2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.

Arm Title

1 mg Baricitinib

Arm Type

Experimental

Arm Description

1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered orally once daily.

Arm Title

4 mg Baricitinib Maximum Extended Enrollment Cohort

Arm Type

Experimental

Arm Description

4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.

Arm Title

2 mg Baricitinib Maximum Extended Enrollment Cohort

Arm Type

Experimental

Arm Description

2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.

Arm Title

1 mg Baricitinib Maximum Extended Enrollment Cohort

Arm Type

Experimental

Arm Description

1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.

Arm Title

Placebo Maximum Extended Enrollment Cohort

Arm Type

Placebo Comparator

Arm Description

Placebo administered orally once daily.

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

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib)

Description

Time Frame

16 Weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib)

Description

Time Frame

16 Weeks

Title

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

Description

Time Frame

16 Weeks

Title

Percentage of Participants Achieving EASI90

Description

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 EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.

Time Frame

16 Weeks

Title

Percent Change From Baseline in EASI Score

Description

Time Frame

Baseline, 16 Weeks

Title

Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

Description

Time Frame

16 Weeks

Title

Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)

Description

Time Frame

16 Weeks

Title

Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)

Description

Time Frame

Baseline, 16 Weeks

Title

Change From Baseline in the Skin Pain Numeric Rating Scale (NRS)

Description

Time Frame

Baseline, 16 Weeks

Title

Percentage of Participants Achieving EASI50

Description

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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and 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 EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.

Time Frame

16 Weeks

Title

Percentage of Participants Achieving IGA of 0

Description

Time Frame

16 Weeks

Title

Change From Baseline in SCORAD

Description

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.

Time Frame

Baseline, 16 Weeks

Title

Percentage of Participants Achieving SCORAD90

Description

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.

Time Frame

16 Weeks

Title

Change From Baseline in Body Surface Area (BSA) Affected

Description

Time Frame

Baseline, 16 Weeks

Title

Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

Description

Percentage of participants developing skin infections requiring antibiotic treatment.

Time Frame

16 Weeks

Title

Percent Change From Baseline in Itch NRS

Description

Time Frame

Baseline, 16 Weeks

Title

Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)

Description

Time Frame

Baseline, 16 Weeks

Title

Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score

Description

Time Frame

Baseline, 16 Weeks

Title

Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)

Description

Time Frame

Baseline, 16 Weeks

Title

Change From Baseline in the Dermatology Life Quality Index (DLQI)

Description

Time Frame

Baseline, 16 Weeks

Title

Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire

Description

Time Frame

Baseline, 16 Weeks

Title

Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm

Description

Time Frame

Baseline, 16 Weeks

Title

Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)

Description

Time Frame

Baseline, 16 Weeks

Title

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement

Description

Time Frame

4 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

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, Jizni Predmesti

State/Province

Plzensky Kraj

ZIP/Postal Code

301 00

Country

Czechia

Facility Name

Kozni ambulance Kutna Hora, s.r.o.

City

Kutna Hora

State/Province

Stredocesky 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

Aarhus Universitehospital Marselisborg Centret

City

Aarhus

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

CHRU de Brest - Hôpital Morvan

City

Brest

ZIP/Postal Code

29200

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

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

Universitätsklinikum Bonn

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

Praxis Dr. Thomas Dirschka

City

Wuppertal

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

42287

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

Hautarztzentrum Kiel

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24103

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

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

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

M S Ramaiah Medical College Hospital

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

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

Jehangir Hospital

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411001

Country

India

Facility Name

Seth GS Medical College & KEM Hospital

City

Mumbai

State/Province

Maharshtra

ZIP/Postal Code

400012

Country

India

Facility Name

Chennai Meenakshi Multispeciality Hospital

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600004

Country

India

Facility Name

Gandhi Hospital

City

Secunderabad

State/Province

Telangana

ZIP/Postal Code

500003

Country

India

Facility Name

MV Hospital and Research Centre

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226003

Country

India

Facility Name

Istituto Clinico Humanitas

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

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

Kawashima Dermatology Clinic

City

Ichikawa-shi

State/Province

Chiba

ZIP/Postal Code

272-0033

Country

Japan

Facility Name

Fumimori Clinic

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

815-0082

Country

Japan

Facility Name

Hiroshima University Hospital

City

Hiroshima-shi

State/Province

Hiroshima-ken

ZIP/Postal Code

734-8551

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

Yokohama City Minato Red Cross Hospital

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Kyoto Prefectural University of Medicine

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Kume Clinic

City

Nishi-ku Sakai-shi

State/Province

Osaka

ZIP/Postal Code

593-8324

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

Iidabashi Clinic

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

102-0072

Country

Japan

Facility Name

Nihonbashi Sakura Clinic

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0025

Country

Japan

Facility Name

Sumire Dermatology Clinic

City

Edogawa-ku

State/Province

Tokyo

ZIP/Postal Code

133-0057

Country

Japan

Facility Name

NTT Medical Center Tokyo

City

Shinagawa-KU

State/Province

Tokyo

ZIP/Postal Code

141-8625

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

Fukuoka University Hospital

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Hospital de Jesus I.A.P.

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06090

Country

Mexico

Facility Name

Grupo Médico CAMINO S.C.

City

México City

State/Province

Distrito Federal

ZIP/Postal Code

03310

Country

Mexico

Facility Name

Clínica Enfermedades Crónicas y Procedimientos Especiales SC

City

Morella

State/Province

Michoacan

ZIP/Postal Code

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 Univ. 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

GBUZ Clinical dermatology and venereological dispensary

City

Krasnodar

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

Chang Gung Memorial Hospital - Kaohsiung

City

Kaohsiung City

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 City

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 City

ZIP/Postal Code

33305

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

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

34688290

Citation

Silverberg JI, DeLozier A, Sun L, Thyssen JP, Kim B, Yosipovitch G, Nunes FP, Gugiu PC, Doll HA, Eichenfield LF. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis. Health Qual Life Outcomes. 2021 Oct 23;19(1):247. doi: 10.1186/s12955-021-01877-8.

Results Reference

derived

PubMed Identifier

34275122

Citation

Thyssen JP, Buhl T, Fernandez-Penas P, Kabashima K, Chen S, Lu N, DeLozier AM, Casillas M, Stander S. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7. Dermatol Ther (Heidelb). 2021 Oct;11(5):1599-1611. doi: 10.1007/s13555-021-00577-x. Epub 2021 Jul 18.

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

PubMed Identifier

33222559

Citation

Reich K, DeLozier AM, Nunes FP, Thyssen JP, Eichenfield LF, Wollenberg A, Ross Terres JA, Watts SD, Chen YF, Simpson EL, Silverberg JI. Baricitinib improves symptoms in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: patient-reported outcomes from two randomized monotherapy phase III trials. J Dermatolog Treat. 2022 May;33(3):1521-1530. doi: 10.1080/09546634.2020.1839008. Epub 2020 Nov 22.

Results Reference

derived

Links:

URL

https://www.lillytrialguide.com/en-US/studies/eczema/JAHL#?postal=

Description

A Study of Baricitinib (LY3009104) in Adults With Moderate to Severe Atopic Dermatitis (Eczema) (BREEZE-AD1)

Learn more about this trial

A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

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