search
Back to results

A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirikizumab
Placebo
Secukinumab
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 Interleukin-23 (IL-23)

Eligibility Criteria

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

Inclusion Criteria:

  • Participant must have chronic plaque psoriasis for at least 6 months.

Exclusion Criteria:

  • Participant must not be breastfeeding or nursing woman.
  • Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months.
  • Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.
  • Participant must not have any other skin conditions (excluding psoriasis).
  • Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz).
  • Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks.
  • Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).

Sites / Locations

  • University of Alabama at Birmingham
  • Bakersfield Dermatology and Skin Cancer Medical Group
  • David Stoll, M.D.
  • California Dermatology and Clinical Research Institute
  • Tien Q. Nguyen, MD inc. DBA First OC Dermatology
  • Keck School of Medicine University of Southern California
  • Dermatology Clinical Trials
  • San Luis Dermatology & Laser Clinic, Inc
  • Clinical Science Institute
  • Park Avenue Dermatology
  • Dermatologic Surgery Specialists, PC
  • Medaphase Inc
  • Meridian Clinical Research
  • Treasure Valley Dermatology
  • University Dermatology
  • Arlington Dermatology
  • Dawes Fretzin Clinical Research
  • The Indiana Clinical Trials Center, PC
  • The South Bend Clinic
  • Dermatology Specialist
  • 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, LLC
  • Bexley Dermatology Research
  • University Hospitals Cleveland Medical Center
  • Wright State Physicians Dermatology
  • Oregon Dermatology and Research Center
  • Oregon Health and Science University
  • Clinical Partners LLC
  • Modern Research Associates PLLC
  • Austin Institute for Clinical Research, Inc.
  • Texas Dermatology and Laser Specialists
  • Jordan Valley Dermatology Center
  • Virginia Clinical Research
  • Dermatology Associates
  • CEDIC-Centro de Investigaciones Clinicas
  • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires Skin
  • Instituto de Neumonología y Dermatología
  • Psoriahue Medicina Interdisciplinaria
  • Clinica Adventista de Belgrano
  • Halitus Instituto Médico
  • Parra Dermatología
  • Woden Dermatology
  • Veracity Clinical Research Pty Ltd
  • Clinical Trials SA Pty Ltd
  • Skin and Cancer Foundation Inc.
  • Fremantle Dermatology
  • Stratica Medical
  • Dr. Chih-ho Hong Medical Inc.
  • Eastern Canada Cutaneous Research Assoicates Ltd
  • The Guenther Dermatology Research Centre
  • Lynderm Research Inc
  • SKiN Centre for Dermatology
  • K. Papp Clinical Research Inc
  • Innovaderm Research Inc
  • Clintrial, s.r.o.
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni Nemocnice U svate Anny
  • Kozni ambulance Kutna Hora, s.r.o.
  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
  • Kozni oddeleni
  • CHU Dupuytren 2
  • CHU de Bordeaux Hopital Saint Andre
  • CH du Mans - Pavillon Claude Monet
  • Cabinet Médical
  • Hopital Saint Eloi
  • CHU de Nice Hopital de L'Archet
  • Chu de Rouen Hopital Charles Nicolle
  • Hopital Larrey
  • Universitätsklinikum Heidelberg
  • Hautarztpraxis Dr. Leitz und Kollegen
  • Universitätsklinikum Tübingen
  • Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Dermatologisches Zentrum Osnabrück Nord
  • Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude
  • Fachklinik Bad Bentheim
  • Universitätsklinikum Schleswig-Holstein
  • Universitätsklinikum Schleswig-Holstein
  • Klin. Forschung Berlin-Mitte GmbH
  • Rothhaar Studien GmbH
  • TFS Trial Form Support GmbH
  • Bacs-Kiskun Megyei Korhaz
  • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
  • Trial Pharma Kft.
  • Allergo-Derm Bakos Kft
  • UNO Medical Trials Kft.
  • Ambrozia Kft.
  • Oroshaza Varosi Onkormanyzat Korhaza
  • MedMare Bt
  • Haemek Medical Center- Dermatology
  • Soroka Medical Center
  • Rambam Medical Center
  • Rabin Medical Center
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Istituto Clinico Humanitas
  • Policlinico Univ. Agostino Gemelli
  • Presidio Ospedaliero Firenze Centro Piero Palagi
  • Policlinico di Tor Vergata
  • Nagoya City University Hospital
  • Juntendo Urayasu Hospital
  • Kurume University Hospital
  • Gunma University Hosptial
  • Asahikawa Medical College Hospital
  • Tokyo Medical University Ibaraki Medical Center
  • Tokai University Hospital
  • Kyoto Prefectural University of Medicine
  • Mie University Hospital
  • Tohoku University Hospital
  • Shinshu University Hospital
  • Ryukyu University Hospital
  • Kansai Medical University Hospital
  • Shiga University of Medical Science Hosptial
  • The University of Tokyo Hospital
  • St. Lukes International Hospital
  • Teikyo University Hospital
  • Nihon University Itabashi Hospital
  • Showa University Hospital
  • Tokyo Medical University Hospital
  • Yamaguchi University Hospital
  • Yamanashi Prefectural Central Hospital
  • Gifu University Hospital
  • Nagasaki University Hospital
  • Osaka City University Hospital
  • Nippon Life Hospital
  • Tokushima University Hospital
  • Wakayama MedicaL University Hospital
  • Ilsan Paik Hospital
  • Seoul National University Bundang Hospital
  • Pusan National University Hospital
  • Gachon University Gil Medical Center
  • Samsung Medical Center
  • Korea University Guro Hospital
  • Konkuk University Medical Center
  • Seoul St. Mary's Hospital
  • Chungang University Hospital
  • Severance Hospital Yonsei University Health System
  • DermMEDICA Sp. z o.o.
  • DermoDent, Centrum Medyczne Czajkowscy
  • Dermed Centrum Medyczne Sp. z o.o.
  • Lubelskie Centrum Diagnostyczne
  • Barbara Rewerska DIAMOND CLINIC
  • Centralny Szpital Kliniczny MSW Klinika Dermatologii
  • Centrum Medyczne Evimed
  • NZOZ ZDROWIE Osteo-Medic
  • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
  • Centrum Badan Klinicznych, PI House
  • Centrum Medyczne Angelius Provita
  • LASER CLINIC Specjalistyczne Gabinety Lekarskie
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
  • AI Centrum Medyczne
  • Santa Cruz Behavioral PSC
  • Office of Dr. Samuel Sanchez PSC
  • Office of Dr. Alma M. Cruz
  • Ponce School of Medicine CAIMED Center
  • GCM Medical Group PSC
  • 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 Ramon y Cajal
  • Hospital Universitario La Paz
  • Centro de Especialidades Mollabao
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario La Fe de Valencia
  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Arm Label

250mg Q4W/250mg Q8W Mirikizumab

250mg Q4W/125mg Q8W Mirikizumab

Placebo/250mg Mirikizumab

300mg Secukinumab

Japan GPP/EP

Arm Description

Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.

Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.

Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.

Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.

Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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.
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
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, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 75% Improvement in PASI 75
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, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥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 signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
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". For all questions, if unanswered the question 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. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
The Palmoplantar PASI 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. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
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 From Baseline 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).
Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
Change From Baseline on the SF-36 Mental Component Summary (MCS)
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2
The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11.
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.
Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
Minimum observed serum Ctrough,ss of mirikizumab
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority)
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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.
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)
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, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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).

Full Information

First Posted
May 14, 2018
Last Updated
March 3, 2021
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03535194
Brief Title
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
June 3, 2020 (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 reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for 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
Interleukin-23 (IL-23)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1484 (Actual)

8. Arms, Groups, and Interventions

Arm Title
250mg Q4W/250mg Q8W Mirikizumab
Arm Type
Experimental
Arm Description
Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
Arm Title
250mg Q4W/125mg Q8W Mirikizumab
Arm Type
Experimental
Arm Description
Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
Arm Title
Placebo/250mg Mirikizumab
Arm Type
Experimental
Arm Description
Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
Arm Title
300mg Secukinumab
Arm Type
Active Comparator
Arm Description
Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
Arm Title
Japan GPP/EP
Arm Type
Experimental
Arm Description
Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Mirikizumab
Other Intervention Name(s)
LY3074828
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
Description
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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.
Time Frame
Week 16
Title
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
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, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a 75% Improvement in PASI 75
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, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 16
Title
Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
Description
The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Time Frame
Week 16
Title
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥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 signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Time Frame
Week 16
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". For all questions, if unanswered the question 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. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Time Frame
Week 16
Title
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Description
The Palmoplantar PASI 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. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
Time Frame
Baseline, Week 16
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 16
Title
Change From Baseline 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 16
Title
Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
Description
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
Time Frame
Baseline, Week 16
Title
Change From Baseline on the SF-36 Mental Component Summary (MCS)
Description
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
Time Frame
Baseline, Week 16
Title
Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2
Description
The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Time Frame
Week 16
Title
Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores
Description
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11.
Description
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.
Time Frame
Baseline, Week 16
Title
Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
Description
Minimum observed serum Ctrough,ss of mirikizumab
Time Frame
Week 16
Title
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority)
Description
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis 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.
Time Frame
Week 16
Title
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)
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, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must have chronic plaque psoriasis for at least 6 months. Exclusion Criteria: Participant must not be breastfeeding or nursing woman. Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months. Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study. Participant must not have any other skin conditions (excluding psoriasis). Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz). Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks. Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
all 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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Bakersfield Dermatology and Skin Cancer Medical Group
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
David Stoll, M.D.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
California Dermatology and Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Tien Q. Nguyen, MD inc. DBA 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
Country
United States
Facility Name
San Luis Dermatology & Laser Clinic, Inc
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
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Dermatologic Surgery Specialists, PC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Medaphase Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Treasure Valley Dermatology
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
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
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
The South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Dermatology Specialist
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
27511
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, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
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 Physicians Dermatology
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
46435
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 Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
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 PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
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
Jordan Valley Dermatology Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Virginia Clinical Research
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
CEDIC-Centro de Investigaciones Clinicas
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425DES
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Buenos Aires Skin
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1055AA0
Country
Argentina
Facility Name
Instituto de Neumonología y Dermatología
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425BEA
Country
Argentina
Facility Name
Psoriahue Medicina Interdisciplinaria
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425DKG
Country
Argentina
Facility Name
Clinica Adventista de Belgrano
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1430EGF
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 and Cancer Foundation Inc.
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Fremantle Dermatology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Stratica Medical
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
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
The Guenther Dermatology Research Centre
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 Inc
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
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 U svate Anny
City
Brno
State/Province
Jihomoravský Kraj
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Kozni ambulance Kutna Hora, s.r.o.
City
Kutna Hora
State/Province
Středočeský Kraj
ZIP/Postal Code
28430
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
Kozni oddeleni
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
CHU Dupuytren 2
City
Limoges
State/Province
Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
CHU de Bordeaux Hopital Saint Andre
City
Bordeaux Cedex
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 de Rouen Hopital Charles Nicolle
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 und Kollegen
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
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
Dermatologisches Zentrum Osnabrück Nord
City
Bramsche
State/Province
Niedersachsen
ZIP/Postal Code
49565
Country
Germany
Facility Name
Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48455
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
Klin. Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rothhaar Studien GmbH
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
TFS Trial Form Support GmbH
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Bacs-Kiskun Megyei Korhaz
City
Kecskemet
State/Province
Bacs-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
Trial Pharma Kft.
City
Puspokladany
State/Province
Hajdu-Bihar
ZIP/Postal Code
4150
Country
Hungary
Facility Name
Allergo-Derm Bakos Kft
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
UNO Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Ambrozia Kft.
City
Budapest
ZIP/Postal Code
1238
Country
Hungary
Facility Name
Oroshaza Varosi Onkormanyzat Korhaza
City
Oroshaza
ZIP/Postal Code
5900
Country
Hungary
Facility Name
MedMare Bt
City
Veszprem
ZIP/Postal Code
8200
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
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Policlinico Univ. Agostino Gemelli
City
Roma
State/Province
Rome
ZIP/Postal Code
00168
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
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
Tokyo Medical University Ibaraki Medical Center
City
Inashiki-gun
State/Province
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
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
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
Shiga University of Medical Science Hosptial
City
Ohtsu-shi
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
St. Lukes International Hospital
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104 8560
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
Showa University Hospital
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
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
Nagasaki University Hospital
City
Nagaski
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
Wakayama MedicaL University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Ilsan Paik Hospital
City
IlsanSeo-gu
State/Province
Goyang-si
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
Pusan National University Hospital
City
Busan
State/Province
Korea
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Korea
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Chungang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-792
Country
Korea, Republic of
Facility Name
DermMEDICA Sp. z o.o.
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-318
Country
Poland
Facility Name
DermoDent, Centrum Medyczne Czajkowscy
City
Osielsko
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
86-031
Country
Poland
Facility Name
Dermed Centrum Medyczne Sp. z o.o.
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne
City
Swidnik
State/Province
Lubelskie
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Barbara Rewerska DIAMOND CLINIC
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW Klinika Dermatologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Medyczne Evimed
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-625
Country
Poland
Facility Name
NZOZ 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
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-611
Country
Poland
Facility Name
LASER CLINIC Specjalistyczne Gabinety Lekarskie
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
AI Centrum Medyczne
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Santa Cruz Behavioral PSC
City
Bayamón
ZIP/Postal Code
00961-6911
Country
Puerto Rico
Facility Name
Office of 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
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
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 Ramon 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
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
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/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/4OGlssjkYoIKEIqGEWMso0?conditionId=5QbmZKQ9SVYRi4IGWDazJj
Description
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

Learn more about this trial

A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

We'll reach out to this number within 24 hrs