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

• ClinicalTrials.gov Identifier: NCT03482011
• Recruitment Status: Completed
• First Posted: March 29, 2018
• Results First Posted: September 25, 2020
• Last Update Posted: September 25, 2020
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: Mirikizumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 530 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 24, 2018
• Actual Primary Completion Date: March 21, 2019
• Actual Study Completion Date: January 16, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mirikizumab; 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).	Drug: Mirikizumab; Administered SC; Other Name: LY3074828
Placebo Comparator: Placebo; 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).	Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline [ Time Frame: Week 16 ]
   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.
2. Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 90) [ Time Frame: Week 16 ]
   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 :

1. Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75) [ Time Frame: Week 4 ]
   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).
2. Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75) [ Time Frame: Week 16 ]
   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).
3. Percentage of Participants Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100) [ Time Frame: Week 16 ]
   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).
4. Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement [ Time Frame: Week 16 ]
   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.
5. Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥1 at Baseline [ Time Frame: Week 16 ]
   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.
6. 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 [ Time Frame: Week 16 ]
   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.
7. Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period [ Time Frame: Week 52 ]
   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).
8. Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline [ Time Frame: Week 16 ]
   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.
9. Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline [ Time Frame: Week 16 ]
   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.
10. Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline [ Time Frame: Week 16 ]
    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.
11. Change From Baseline on the Short Form (SF)-36 Physical Component Summary (PCS) [ Time Frame: Baseline, Week 16 ]
    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.
12. Change From Baseline on the SF-36 Mental Component Summary (MCS) [ Time Frame: Baseline, Week 16 ]
    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.
13. Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline [ Time Frame: Baseline, Week 16 ]
    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.
14. Change From Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) [ Time Frame: Baseline, Week 16 ]
    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.
15. Change From Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11 [ Time Frame: Baseline, Week 16 ]
    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.
16. Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1) [ Time Frame: Week 16 ]
    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.
17. Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16 [ Time Frame: Week 16: Day 113 ]
    Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab at Week 16.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Connecticut

Univ of Connecticut

Farmington, Connecticut, United States, 06032

United States, Florida

Florida Academic Dermatology Centers

Coral Gables, Florida, United States, 33134

Renstar Medical Research

Ocala, Florida, United States, 34470

Forward Clinical Trials, Inc

Tampa, Florida, United States, 33624

United States, Illinois

Arlington Dermatology

Rolling Meadows, Illinois, United States, 60008

United States, Indiana

The South Bend Clinic

South Bend, Indiana, United States, 46617

United States, Oregon

Oregon Medical Research Center

Portland, Oregon, United States, 97223

United States, Pennsylvania

Dermatology and Skin Surgery Center

Exton, Pennsylvania, United States, 19341

United States, Utah

University of Utah MidValley Dematology

Murray, Utah, United States, 84107

United States, Washington

Multicare Health System

Tacoma, Washington, United States, 98405

Germany

Gemeinschaftspraxis Mahlow

Mahlow, Brandenburg, Germany, 15831

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen, Germany, 48149

Praxis Gerlach

Dresden, Sachsen, Germany, 01097

Charité Universitätsmedizin Berlin

Berlin, Germany, 10117

ISA GmbH

Berlin, Germany, 10789

Universitätsklinikum Hamburg - Eppendorf

Hamburg, Germany, 20246

Clinical Research Hamburg GmbH

Hamburg, Germany, 22143

Japan

Toho University School of Medicine, Sakura Hospital

Sakura, Chiba, Japan, 285-8741

Takagi Dermatological Clinic

Obihiro, Hokkaido, Japan, 080-0013

Kanto Rosai Hospital

Kawasaki, Kanagawa, Japan, 211-8510

Yokohama City University Hospital

Yokohama, Kanagawa, Japan, 236-0004

Ryukyu University Hospital

Nakagami-gun, Okinawa, Japan, 903-0215

Kume Clinic

Nishi-ku Sakai-shi, Osaka, Japan, 593-8324

Shimane University Hospital

Izumo, Shimane, Japan, 693-8501

Tokyo Medical University Hachioji Medical Center

Hachioji, Tokyo, Japan, 193-0998

NTT Medical Center Tokyo

Shinagawa-KU, Tokyo, Japan, 141-8625

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan, 160-0023

Seibo Hospital

Shinjuku-ku, Tokyo, Japan, 161-8521

Shirasaki Clinic

Takaoka-shi, Toyama, Japan, 9330871

Korea, Republic of

Bucheon St. Mary's Hospital

Bucheon,, Gyeonggi-do, Korea, Republic of, 14647

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620

Bundang CHA General Hospital

Sungnam-si, Gyeonggi-do, Korea, Republic of, 13496

Ajou University Hospital

Suwon, Gyeonggi-do, Korea, Republic of, 16499

Kyung Hee University Hospital

Seoul, Korea, Korea, Republic of, 02447

Korea University Guro Hospital

Seoul, Korea, Korea, Republic of, 08308

Ulsan University Hospital

Ulsan, Korea, Korea, Republic of, 44033

Chungnam National University Hospital

Daejeon, Korea, Republic of, 35015

Chonnam National University Hospital

Gwangju, Korea, Republic of, 61469

Severance Hospital Yonsei University Health System

Seoul, Korea, Republic of, 03722

Hanyang University Medical Center

Seoul, Korea, Republic of, 04763

Konkuk University Hospital

Seoul, Korea, Republic of, 05030

Mexico

Centro Medico del Angel S.C.

Mexicali, Baja California, Mexico, 21100

Hospital de Jesus

Mexico City, Distrito Federal, Mexico, 06090

Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio

Zapopan, Jalisco, Mexico, 45190

Clínica Enfermedades Crónicas y Procedimientos Especiales SC

Morella, Michoacan, Mexico, 58249

B&B Investigaciones Medicas, SC

Mazatlan, Sinaloa, Mexico, 82140

Kohler Milstein Research, S.A. de C.V.

Merida, Yucatan, Mexico, 97070

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

Distrito Federal, Mexico, 3100

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, Mexico, 34000

Poland

NZOZ ZDROWIE Osteo-Medic

Bialystok, Poland, 15-351

"Dermed" Centrum Medyczne Sp. z o.o.

Lodz, Poland, 90-265

Lubelskie Centrum Diagnostyczne

Swidnik, Poland, 21-040

Centrum Medyczne AMED

Warszawa, Poland, 01-518

DermMEDICA Sp. z o.o.

Wroclaw, Poland, 51-318

Puerto Rico

Office of Dr. Alma M. Cruz

Carolina, Puerto Rico, 00985

GCM Medical Group PSC

San Juan, Puerto Rico, 00909

Russian Federation

GBUZ Clinical dermatology and venereological dispensary

Krasnodar, Russian Federation, 350000

State scientific centre for dermatovenerology and cosmetolog

Moscow, Russian Federation, 107076

First Moscow State Medical University n.a. Sechenov

Moscow, Russian Federation, 119991

GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'

Smolensk, Russian Federation, 214000

SPb SBHI Skin-venerologic dispensary #10

St. Petersburg, Russian Federation, 194021

Tver State Medical University

Tver, Russian Federation, 170100

Taiwan

National Taiwan University Hospital

Taipei City, Zhongzheng District, Taiwan, 100

National Taiwan University Hospital Hsin-Chu

Hsinchu, Taiwan, 30059

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung, Taiwan, 83301

Taipei Medical University- Shuang Ho Hospital

New Taipei City, Taiwan, 23561

Chung Shan Medical University Hospital

Taichung City, Taiwan, 40201

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Chang Gung Memorial Hospital - Linkou

Taoyuan Hsien, Taiwan, 10508

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: 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); Eli Lilly and Company

  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:

Study Protocol  [PDF] December 12, 2018

Statistical Analysis Plan  [PDF] March 28, 2019

More Information

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03482011
• Other Study ID Numbers: 16505; I6T-MC-AMAK ( Other Identifier: Eli Lilly and Company ); 2017-003298-32 ( EudraCT Number )
• First Posted: March 29, 2018
• Results First Posted: September 25, 2020
• Last Update Posted: September 25, 2020
• Last Verified: February 1, 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• URL: https://vivli.org/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:

Psoriasis; IL-23

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Mirikizumab; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Ulcer Agents; Gastrointestinal Agents