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A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

Primary Purpose

Psoriasis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirikizumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring IL-23, Interleukin-23, Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Participant must have completed the last visit of an eligible study period of originating study.
  • Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential.

Exclusion Criteria:

  • Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study.
  • Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.

Sites / Locations

  • University of Alabama at Birmingham
  • Zenith Research, Inc.
  • California Dermatology & Clinical Research Institute
  • First OC Dermatology
  • Keck School of Medicine University of Southern California
  • Dermatology Clinical Trials
  • San Luis Dermatology & Laser Clinic
  • Clinical Science Institute
  • Univ of Connecticut
  • Florida Academic Centers Research and Education, LLC
  • Renstar Medical Research
  • Park Avenue Dermatology
  • ForCare Clinical Research
  • Dermatologic Surgery Specialists, PC
  • Meridian Clinical Research
  • Advanced Clinical Research LLC
  • University Dermatology
  • Arlington Dermatology
  • Dawes Fretzin Clinical Research Group, LLC
  • The Indiana Clinical Trials Center
  • The South Bend Clinic Center for Research
  • Forefront Research
  • DelRicht Research
  • Dermatology and Skin Cancer Specialists
  • Lawrence J Green, M.D, LLC
  • ORA, Inc
  • Central Dermatology PC
  • Psoriasis Treatment Center of Central New Jersey
  • Mount Sinai School of Medicine Dermatology Clinical Trials
  • PMG Research of Cary, LLC
  • University of North Carolina Dermatology and Skin Cancer Cen
  • PMG Research of Wilmington
  • Bexley Dermatology Research
  • University Hospitals Cleveland Medical Center
  • Wright State Univ School of Medicine
  • Oregon Dermatology and Research Center
  • Oregon Medical Research Center
  • Oregon Health and Science University
  • The Pennsylvania Centre for Dermatology, LLC
  • Clinical Partners, LLC
  • Modern Research Associates
  • Austin Institute for Clinical Research
  • Texas Dermatology and Laser Specialists
  • University of Utah
  • Virginia Clinical Research, Inc.
  • Dermatology Associates
  • MultiCare Good Samaritan Hospital
  • Dermatology
  • Instituto de Neumonología Y Dermatología
  • Psoriahue
  • Buenos Aires Skin
  • Clinica Adventista Belgrano
  • Centro de Investigaciones Metabólicas (CINME)
  • Halitus Instituto Médico
  • Parra Dermatología
  • Woden Dermatology
  • Veracity Clinical Research Pty Ltd
  • Clinical Trials SA Pty Ltd
  • Skin Health Institute Inc.
  • Fremantle Dermatology
  • Kirk Barber Research
  • Alberta DermaSurgery Centre
  • Dr. Chih-ho Hong Medical Inc.
  • Eastern Canada Cutaneous Research Assoicates Ltd
  • Guenther Research Inc.
  • Lynderm Research Inc.
  • SKiN Centre for Dermatology
  • K. Papp Clinical Research
  • Innovaderm Research Inc
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni Nemocnice U svate Anny
  • Nemocnice AGEL Novy Jicin a.s.
  • Clintrial s.r.o.
  • Kožní ambulance Kutná Hora, s.r.o.
  • Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z.
  • CHU Dupuytren 2
  • CHU de Bordeaux Hop St ANDRE
  • CH du Mans - Pavillon Claude Monet
  • Cabinet Médical
  • Hopital Saint Eloi
  • CHU de Nice Hopital de L'Archet
  • CHU Charles Nicolle in Rouen
  • Hopital Larrey
  • Universitätsklinikum Heidelberg
  • Hautarztpraxis Dr. Leitz
  • Universitätsklinikum Tübingen
  • Dermatologische Gemeinschaftspraxis Mahlow
  • Rosenpark Research GmbH
  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Fachklinik Bad Bentheim
  • Dermatologisches Zentrum Osnabrück Nord
  • Elbe Klinikum Buxtehude
  • Universitätsklinikum Münster
  • Hautarztpraxis Dr. Gerlach
  • Universitätsklinikum Schleswig-Holstein
  • Universitätsklinikum Schleswig-Holstein
  • Charité Campus Virchow-Klinikum
  • Klin. Forschung Berlin-Mitte GmbH
  • Rothhaar Studien
  • ISA GmbH
  • Universitaetsklinikum Hamburg-Eppendorf
  • TFS Trial Form Support GmbH
  • Clinical Research Hamburg GmbH
  • Oroshaza Varosi Onkormanyzat Korhaza
  • Bacs-Kiskun Megyei Korhaz
  • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
  • Allergo-Derm Bakos Kft
  • Medmare Bt
  • Uno Medical Trials Kft.
  • Ambrozia Kft.
  • Haemek Medical Center- Dermatology
  • Soroka Medical Center
  • Rambam Medical Center
  • Rabin Medical Center
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Policlinico Gemelli - Università Cattolica del Sacro Cuore
  • Istituto Clinico Humanitas
  • Presidio Ospedaliero Firenze Centro Piero Palagi
  • Policlinico di Tor Vergata
  • Nagoya City University Hospital
  • Toho University School of Medicine, Sakura Hospital
  • Juntendo Urayasu Hospital
  • Kurume University Hospital
  • Gunma University Hosptial
  • Asahikawa Medical College Hospital
  • Takagi Dermatology
  • Tokyo Medical University Ibaraki Medical Center
  • Tokai University Hospital- Isehara Campus
  • Kanto Rosai Hospital
  • Yokohama City University Hospital
  • Mie University Hospital
  • Tohoku University Hospital
  • Shinshu University Hospital
  • Ryukyu University Hospital
  • Kansai Medical University Hospital
  • Kume Clinic
  • Shiga University of Medical Science Hosptial
  • Shimane University Hospital
  • The University of Tokyo Hospital
  • Tokyo Medical University Hachioji Medical Center
  • Teikyo University Hospital
  • Nihon University Itabashi Hospital
  • NTT Medical Center Tokyo
  • Showa University Hospital
  • Tokyo Medical University Hospital
  • Seibo Hospital
  • Takaokashi Shirasaki Dermatology Clinic
  • Yamaguchi University Hospital
  • Yamanashi Prefectural Central Hospital
  • Gifu University Hospital
  • Kyoto Furitsu Medical University Hospital
  • Nagasaki University Hospital
  • Osaka City University Hospital
  • Nippon Life Hospital
  • Tokushima University Hospital
  • St. Luke's International Hospital
  • Wakayama Medical University Hospital
  • Bucheon St. Mary's Hospital
  • Ilsan Paik Hospital
  • Seoul National University Bundang Hospital
  • CHA Bundang Medical Center, CHA University
  • Ajou University Hospital
  • Pusan National University Hospital
  • Chungnam National University Hospital
  • Chonnam National University Hospital
  • Gachon University Gil Hospital
  • Kyung Hee University Hospital
  • Hanyang University Medical Center
  • Seoul St. Mary's Hospital
  • Samsung Medical Center
  • Korea University Guro Hospital
  • Ulsan University Hospital
  • Severance Hospital, Yonsei University Health System
  • Konkuk University Medical Center
  • Chungang University Hospital
  • Centro Medico del Angel
  • Hospital de Jesus I.A.P.
  • Grupo Clinico CATEI Sociedad Civil
  • Clinica De Enfermedades Cronicas y Procedimientos Especiales
  • B&B Investigaciones Medicas, SC
  • Köhler & Milstein Research
  • RM Pharma Specialists S.A. de C.V.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C
  • dermMedica Sp. z o.o.
  • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
  • Dermed Centrum Medyczne Sp. z o.o.
  • Lubelskie Centrum Diagnostyczne
  • Diamond Clinic
  • Centrum Medyczne AMED
  • Centrum Medyczne Evimed
  • NZOZ ZDROWIE Osteo-Medic
  • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
  • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
  • LASER CLINIC Specjalistyczne Gabinety Lekarskie
  • Centralny Szpital Kliniczny MSW Klinika Dermatologii
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Centrum Medyczne Angelius Provita
  • Santa Cruz Behavioral PSC
  • Dr. Samuel Sanchez PSC
  • Office of Dr. Alma M. Cruz
  • Ponce School of Medicine CAIMED Center
  • GCM Medical Group, PSC - Hato Rey Site
  • GBUZ Clinical dermatology and venereological dispensary
  • State scientific centre for dermatovenerology and cosmetolog
  • GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
  • SPb SBHI Skin-venerologic dispensary #10
  • Tver State Medical University
  • Hospital Marina Baixa
  • Hospital Germans Trias i Pujol
  • Hospital de Manises
  • Hospital De Basurto
  • Hospital del Mar
  • Hospital Reina Sofia
  • Hospital Infanta Leonor
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario La Paz
  • Centro de Especialidades Mollabao
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario La Fe de Valencia
  • National Taiwan University Hospital - Hsinchu branch
  • Chang Gung Memorial Hospital - Kaohsiung Branch
  • Taipei Medical University Shuang Ho Hospital
  • Chung Shan Medical University Hospital
  • National Cheng-Kung Uni. Hosp.
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital - Linkou
  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

125 Milligram (mg) Mirikizumab Q8W

250 mg Mirikizumab Q8W Excluding Secukinumab

Secukinumab/250 mg Mirikizumab Q8W

Arm Description

Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).

Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)

Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

Secondary Outcome Measures

Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported.
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold.
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
The PPASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).

Full Information

First Posted
June 4, 2018
Last Updated
March 17, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03556202
Brief Title
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Official Title
A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to a strategic business decision made by the Sponsor.
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
IL-23, Interleukin-23, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Initially double-blind (until original, pivotal studies AMAK [NCT03482011] and AMAJ [NCT03535194] are locked and unblinded), then open-label.
Allocation
Non-Randomized
Enrollment
1936 (Actual)

8. Arms, Groups, and Interventions

Arm Title
125 Milligram (mg) Mirikizumab Q8W
Arm Type
Experimental
Arm Description
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
Arm Title
250 mg Mirikizumab Q8W Excluding Secukinumab
Arm Type
Experimental
Arm Description
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)
Arm Title
Secukinumab/250 mg Mirikizumab Q8W
Arm Type
Experimental
Arm Description
Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Intervention Type
Drug
Intervention Name(s)
Mirikizumab
Other Intervention Name(s)
LY3074828
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1
Description
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
Time Frame
Week 104
Title
Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90
Description
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Time Frame
Week 104
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Description
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Time Frame
Week 104
Title
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline
Description
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported.
Time Frame
Week 104
Title
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
Description
The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold.
Time Frame
Week 104
Title
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Description
The PPASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.
Time Frame
Baseline, Week 104
Title
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
Description
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
Time Frame
Baseline, Week 104
Title
Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
Description
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
Time Frame
Baseline, Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must have completed the last visit of an eligible study period of originating study. Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential. Exclusion Criteria: Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study. Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
1-877-CTLILLY (1-877-285-4559) or 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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Zenith Research, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Keck School of Medicine University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Dermatology Clinical Trials
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660-7831
Country
United States
Facility Name
San Luis Dermatology & Laser Clinic
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Univ of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-2840
Country
United States
Facility Name
Florida Academic Centers Research and Education, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Dermatologic Surgery Specialists, PC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Advanced Clinical Research LLC
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
University Dermatology
City
Darien
State/Province
Illinois
ZIP/Postal Code
60561
Country
United States
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
The South Bend Clinic Center for Research
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Forefront Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
DelRicht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Dermatology and Skin Cancer Specialists
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Lawrence J Green, M.D, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
ORA, Inc
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Central Dermatology PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Mount Sinai School of Medicine Dermatology Clinical Trials
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
PMG Research of Cary, LLC
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
University of North Carolina Dermatology and Skin Cancer Cen
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Facility Name
Bexley Dermatology Research
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Wright State Univ School of Medicine
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Pennsylvania Centre for Dermatology, LLC
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
University of Utah
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
MultiCare Good Samaritan Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Dermatology
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1060ABN
Country
Argentina
Facility Name
Instituto de Neumonología Y Dermatología
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Psoriahue
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1425DKG
Country
Argentina
Facility Name
Buenos Aires Skin
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
1055
Country
Argentina
Facility Name
Clinica Adventista Belgrano
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Halitus Instituto Médico
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1122AAF
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
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 Health Institute 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
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Alberta DermaSurgery Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Eastern Canada Cutaneous Research Assoicates Ltd
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H1Z2
Country
Canada
Facility Name
Guenther Research Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P1X2
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Innovaderm Research Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
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 U svate Anny
City
Brno
State/Province
Jihomoravský Kraj
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice AGEL Novy Jicin a.s.
City
Novy Jicin
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Clintrial s.r.o.
City
Praha
State/Province
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Kožní ambulance Kutná Hora, s.r.o.
City
Kutna Hora
State/Province
Středočeský Kraj
ZIP/Postal Code
28401
Country
Czechia
Facility Name
Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z.
City
Usti nad Labem
State/Province
Ustecký Kraj
ZIP/Postal Code
40113
Country
Czechia
Facility Name
CHU Dupuytren 2
City
Limoges
State/Province
Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
CHU de Bordeaux Hop St ANDRE
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
CH du Mans - Pavillon Claude Monet
City
Le Mans Cedex 1
ZIP/Postal Code
72037
Country
France
Facility Name
Cabinet Médical
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice Hopital de L'Archet
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
CHU Charles Nicolle in Rouen
City
Rouen cedex
ZIP/Postal Code
76036
Country
France
Facility Name
Hopital Larrey
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Hautarztpraxis Dr. Leitz
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70178
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Dermatologische Gemeinschaftspraxis Mahlow
City
Mahlow
State/Province
Brandenburg
ZIP/Postal Code
15831
Country
Germany
Facility Name
Rosenpark Research 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
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Facility Name
Dermatologisches Zentrum Osnabrück Nord
City
Bramsche
State/Province
Niedersachsen
ZIP/Postal Code
49565
Country
Germany
Facility Name
Elbe Klinikum Buxtehude
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Hautarztpraxis Dr. Gerlach
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01097
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
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klin. Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rothhaar Studien
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
ISA GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
TFS Trial Form Support GmbH
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Clinical Research Hamburg GmbH
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Oroshaza Varosi Onkormanyzat Korhaza
City
Oroshaza
State/Province
Bekes
ZIP/Postal Code
5900
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz
City
Kecskemét
State/Province
Bács-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Allergo-Derm Bakos Kft
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Medmare Bt
City
Veszprém
State/Province
Veszprém City
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Uno Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Ambrozia Kft.
City
Budapest
ZIP/Postal Code
1238
Country
Hungary
Facility Name
Haemek Medical Center- Dermatology
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3525408
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 Gemelli - Università Cattolica del Sacro Cuore
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
Presidio Ospedaliero Firenze Centro Piero Palagi
City
Firenze
ZIP/Postal Code
50125
Country
Italy
Facility Name
Policlinico di Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Toho University School of Medicine, Sakura Hospital
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Juntendo Urayasu Hospital
City
Urayasu
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Gunma University Hosptial
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Asahikawa Medical College Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Takagi Dermatology
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Tokyo Medical University Ibaraki Medical Center
City
Inashiki
State/Province
Ibaraki
ZIP/Postal Code
300-0332
Country
Japan
Facility Name
Tokai University Hospital- Isehara Campus
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1143
Country
Japan
Facility Name
Kanto Rosai Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-8510
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Ryukyu University Hospital
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Kansai Medical University Hospital
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Kume Clinic
City
Nishi-ku Sakai-shi
State/Province
Osaka
ZIP/Postal Code
593 8324
Country
Japan
Facility Name
Shiga University of Medical Science Hosptial
City
Ōtsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-0021
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173 8606
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-KU
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-8555
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Seibo Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
161-8521
Country
Japan
Facility Name
Takaokashi Shirasaki Dermatology Clinic
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-0871
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
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
Kyoto Furitsu Medical University Hospital
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Nippon Life Hospital
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-0012
Country
Japan
Facility Name
Bucheon St. Mary's Hospital
City
Bucheon,
State/Province
Gyeonggi-do
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Ilsan Paik Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Sungnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Korea
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Korea
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Korea
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
State/Province
Korea
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
8308
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
State/Province
Ulsan-Kwangyǒkshi
ZIP/Postal Code
44033
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
Chungang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Centro Medico del Angel
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Hospital de Jesus I.A.P.
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Grupo Clinico CATEI Sociedad Civil
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44657
Country
Mexico
Facility Name
Clinica De Enfermedades Cronicas y Procedimientos Especiales
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58249
Country
Mexico
Facility Name
B&B Investigaciones Medicas, SC
City
Mazatlan
State/Province
Sinaloa
ZIP/Postal Code
82140
Country
Mexico
Facility Name
Köhler & Milstein Research
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
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
dermMedica Sp. z o.o.
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
51-318
Country
Poland
Facility Name
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
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
Diamond Clinic
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-518
Country
Poland
Facility Name
Centrum Medyczne Evimed
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-625
Country
Poland
Facility Name
NZOZ ZDROWIE Osteo-Medic
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
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 sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-113
Country
Poland
Facility Name
LASER CLINIC Specjalistyczne Gabinety Lekarskie
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW Klinika Dermatologii
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
State/Province
Łódzkie
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Santa Cruz Behavioral PSC
City
Bayamón
ZIP/Postal Code
00961-6911
Country
Puerto Rico
Facility Name
Dr. Samuel Sanchez PSC
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Facility Name
Office of Dr. Alma M. Cruz
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
Facility Name
Ponce School of Medicine CAIMED Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
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
GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
City
Smolensk
ZIP/Postal Code
214000
Country
Russian Federation
Facility Name
SPb SBHI Skin-venerologic dispensary #10
City
St. Petersburg
ZIP/Postal Code
194021
Country
Russian Federation
Facility Name
Tver State Medical University
City
Tver
ZIP/Postal Code
170100
Country
Russian Federation
Facility Name
Hospital Marina Baixa
City
Villajoyosa
State/Province
Alicante
ZIP/Postal Code
03570
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
State/Province
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Manises
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Hospital De Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
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
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
National Taiwan University Hospital - Hsinchu branch
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Kaohsiung Branch
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 Uni. Hosp.
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 - Linkou
City
Taoyuan Hsien
ZIP/Postal Code
10508
Country
Taiwan
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom

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.
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/5ZNG4OpNpmWK8CeycIMWaA
Description
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

Learn more about this trial

A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

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