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A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-1)

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirikizumab
Placebo
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 Psoriasis, IL-23

Eligibility Criteria

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

Inclusion Criteria:

  • Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria:

    • plaque psoriasis involving ≥10% BSA and absolute PASI score ≥12 in affected skin at screening and baseline
    • sPGA score of ≥3 at screening and baseline
  • Candidate for systemic therapy and/or phototherapy for psoriasis.

Exclusion Criteria:

  • 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 laboratory values at screening, that in the opinion of the investigator, would potentially affect participant safety within the study or of interfering with the interpretation of data.
  • Breastfeeding or nursing women.
  • Have had serious, opportunistic, or chronic/recurring infection within 3 months prior to screening.
  • 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.
  • Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.
  • Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.
  • Have received topical psoriasis treatment within 14 days prior to baseline.
  • Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 12 weeks prior to baseline.
  • Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational.

Sites / Locations

  • Univ of Connecticut
  • Florida Academic Dermatology Centers
  • Renstar Medical Research
  • Forward Clinical Trials, Inc
  • Arlington Dermatology
  • The South Bend Clinic
  • Oregon Medical Research Center
  • Dermatology and Skin Surgery Center
  • University of Utah MidValley Dematology
  • Multicare Health System
  • Gemeinschaftspraxis Mahlow
  • Universitätsklinikum Münster
  • Praxis Gerlach
  • Charité Universitätsmedizin Berlin
  • ISA GmbH
  • Universitätsklinikum Hamburg - Eppendorf
  • Clinical Research Hamburg GmbH
  • Toho University School of Medicine, Sakura Hospital
  • Takagi Dermatological Clinic
  • Kanto Rosai Hospital
  • Yokohama City University Hospital
  • Ryukyu University Hospital
  • Kume Clinic
  • Shimane University Hospital
  • Tokyo Medical University Hachioji Medical Center
  • NTT Medical Center Tokyo
  • Tokyo Medical University Hospital
  • Seibo Hospital
  • Shirasaki Clinic
  • Bucheon St. Mary's Hospital
  • Seoul National University Bundang Hospital
  • Bundang CHA General Hospital
  • Ajou University Hospital
  • Kyung Hee University Hospital
  • Korea University Guro Hospital
  • Ulsan University Hospital
  • Chungnam National University Hospital
  • Chonnam National University Hospital
  • Severance Hospital Yonsei University Health System
  • Hanyang University Medical Center
  • Konkuk University Hospital
  • Centro Medico del Angel S.C.
  • Hospital de Jesus
  • Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
  • Clínica Enfermedades Crónicas y Procedimientos Especiales SC
  • B&B Investigaciones Medicas, SC
  • Kohler Milstein Research, S.A. de C.V.
  • RM Pharma Specialists S.A. de C.V.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C
  • NZOZ ZDROWIE Osteo-Medic
  • "Dermed" Centrum Medyczne Sp. z o.o.
  • Lubelskie Centrum Diagnostyczne
  • Centrum Medyczne AMED
  • DermMEDICA Sp. z o.o.
  • Office of Dr. Alma M. Cruz
  • GCM Medical Group PSC
  • GBUZ Clinical dermatology and venereological dispensary
  • State scientific centre for dermatovenerology and cosmetolog
  • First Moscow State Medical University n.a. Sechenov
  • 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
  • National Taiwan University Hospital
  • National Taiwan University Hospital Hsin-Chu
  • Chang Gung Memorial Hospital - Kaohsiung
  • Taipei Medical University- Shuang Ho Hospital
  • Chung Shan Medical University Hospital
  • National Cheng Kung University Hospital
  • Chang Gung Memorial Hospital - Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirikizumab

Placebo

Arm Description

Induction Period: Participants received 250 milligrams (mg) mirikizumab administered subcutaneously (SC) every 4 weeks (Q4W). Maintenance Period: Participants received one of the four options below: Placebo administered SC every 8 weeks (Q8W) for responders (≥PASI 90). 125 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for non-responders (<PASI 90).

Induction Period: Participants received placebo administered SC Q4W. Maintenance Period: Participants received one of the two options below: Placebo administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48 for non-responders (< PASI 90).

Outcomes

Primary Outcome Measures

Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline
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.
Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (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, 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 From Baseline in PASI (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 Achieving a ≥75% Improvement From Baseline in PASI (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 Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (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, 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) Symptoms Score of 0 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 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.
Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period
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).
Change 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). LS Mean was calculated using 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 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). LS Mean was calculated using 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 From Baseline on the Short Form (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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline
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 on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Change From Baseline in Quick Inventory of Depressive Symptomology (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. LS Mean was calculated using ANCOVA model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)
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.
Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16
Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab at Week 16.

Full Information

First Posted
March 23, 2018
Last Updated
August 31, 2020
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03482011
Brief Title
A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Acronym
OASIS-1
Official Title
A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-1
Study Type
Interventional

2. Study Status

Record Verification Date
February 1, 2020
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
January 16, 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 purpose of this study is to evaluate the efficacy and safety 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
Psoriasis, IL-23

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mirikizumab
Arm Type
Experimental
Arm Description
Induction Period: Participants received 250 milligrams (mg) mirikizumab administered subcutaneously (SC) every 4 weeks (Q4W). Maintenance Period: Participants received one of the four options below: Placebo administered SC every 8 weeks (Q8W) for responders (≥PASI 90). 125 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for non-responders (<PASI 90).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Induction Period: Participants received placebo administered SC Q4W. Maintenance Period: Participants received one of the two options below: Placebo administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48 for non-responders (< PASI 90).
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
Primary Outcome Measure Information:
Title
Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline
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.
Time Frame
Week 16
Title
Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (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, 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 From Baseline in PASI (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 4
Title
Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (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 Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (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, 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) Symptoms Score of 0 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 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
Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period
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 52
Title
Change 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
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). LS Mean was calculated using 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
Week 16
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). LS Mean was calculated using 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
Week 16
Title
Change From Baseline on the Short Form (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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Time Frame
Baseline, Week 16
Title
Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline
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
Baseline, Week 16
Title
Change From Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)
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. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Quick Inventory of Depressive Symptomology (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. LS Mean was calculated using ANCOVA model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Time Frame
Baseline, Week 16
Title
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)
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
Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16
Description
Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab at Week 16.
Time Frame
Week 16: Day 113

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria: plaque psoriasis involving ≥10% BSA and absolute PASI score ≥12 in affected skin at screening and baseline sPGA score of ≥3 at screening and baseline Candidate for systemic therapy and/or phototherapy for psoriasis. Exclusion Criteria: 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 laboratory values at screening, that in the opinion of the investigator, would potentially affect participant safety within the study or of interfering with the interpretation of data. Breastfeeding or nursing women. Have had serious, opportunistic, or chronic/recurring infection within 3 months prior to screening. 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. Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results. Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline. Have received topical psoriasis treatment within 14 days prior to baseline. Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 12 weeks prior to baseline. Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Univ of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Florida Academic Dermatology Centers
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
Forward Clinical Trials, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
The South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Dermatology and Skin Surgery Center
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
University of Utah MidValley Dematology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Multicare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Gemeinschaftspraxis Mahlow
City
Mahlow
State/Province
Brandenburg
ZIP/Postal Code
15831
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Praxis Gerlach
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01097
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
ISA GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Universitätsklinikum Hamburg - Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Clinical Research Hamburg GmbH
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Toho University School of Medicine, Sakura Hospital
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Takagi Dermatological Clinic
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
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
Ryukyu University Hospital
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Kume Clinic
City
Nishi-ku Sakai-shi
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-KU
State/Province
Tokyo
ZIP/Postal Code
141-8625
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
Shirasaki Clinic
City
Takaoka-shi
State/Province
Toyama
ZIP/Postal Code
9330871
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
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Bundang CHA General Hospital
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
Kyung Hee University Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
02447
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
Ulsan University Hospital
City
Ulsan
State/Province
Korea
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Konkuk University Hospital
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Centro Medico del Angel S.C.
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Hospital de Jesus
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45190
Country
Mexico
Facility Name
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
City
Morella
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
Kohler Milstein Research, S.A. de C.V.
City
Merida
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
NZOZ ZDROWIE Osteo-Medic
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
"Dermed" Centrum Medyczne Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
01-518
Country
Poland
Facility Name
DermMEDICA Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Office of Dr. Alma M. Cruz
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
Facility Name
GCM Medical Group PSC
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GBUZ Clinical dermatology and venereological dispensary
City
Krasnodar
ZIP/Postal Code
350000
Country
Russian Federation
Facility Name
State scientific centre for dermatovenerology and cosmetolog
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
First Moscow State Medical University n.a. Sechenov
City
Moscow
ZIP/Postal Code
119991
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
National Taiwan University Hospital
City
Taipei City
State/Province
Zhongzheng District
ZIP/Postal Code
100
Country
Taiwan
Facility Name
National Taiwan University Hospital Hsin-Chu
City
Hsinchu
ZIP/Postal Code
30059
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Kaohsiung
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Taipei Medical University- Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Taoyuan Hsien
ZIP/Postal Code
10508
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis

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