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A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Mirikizumab

Placebo

About this trial

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

Eligibility Criteria

18 Years - 75 Years (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% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline
- sPGA score of ≥3 at screening and baseline
Candidate for biologic treatment for psoriasis.

Exclusion Criteria:

Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
Breastfeeding or nursing (lactating) women.
Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.
Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to 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 8 weeks prior to baseline.
Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).

Sites / Locations

Renstar Medical Research
Forward Clinical Trials, Inc
The Indiana Clinical Trials Center, PC
The South Bend Clinic
DS Research
Dr. Shondra Smith MD
Central Dermatology PC
Psoriasis Treatment Center of Central New Jersey
Oregon Dermatology and Research Center
Clinical Partners LLC
Menter Dermatology Research Institute
Dermatology Associates
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Grupo Dermatologico de Carolina
Ponce School of Medicine CAIMED Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

30 mg Mirikizumab

100 mg Mirikizumab

300 mg Mirikizumab

Placebo

Arm Description

30 mg Mirikizumab administered subcutaneously (SC) every 8 weeks (Q8W).

100 mg Mirikizumab administered SC Q8W.

300 mg Mirikizumab administered SC Q8W.

Placebo administered SC Q8W.

Outcomes

Primary Outcome Measures

Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (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 With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

The 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 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 a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1

The sPGA is the physician's determination of the participant's PsO lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 16 were considered non-responders for non-responder Imputation (NRI) analysis.

Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score

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. The total score was calculated by summing the 8 individual items and ranged from 0 to 80, higher scores indicated greater symptom/sign severity. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region [United States/Outside United States (US/OUS)], previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = heterogeneous autoregressive.

Mean Change (Improvement) From Baseline on the Patient Global Assessment

The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.

Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score

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). Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.

Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, geographic region (US/OUS), and previous therapy (yes/no) as fixed factors and baseline value as covariate.

Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104

Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104

Full Information

NCT ID

NCT02899988

First Posted

September 9, 2016

Last Updated

June 5, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02899988

Brief Title

A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis

Official Title

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

August 15, 2019

Overall Recruitment Status

Completed

Study Start Date

September 14, 2016 (Actual)

Primary Completion Date

June 19, 2017 (Actual)

Study Completion Date

May 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy of the study drug 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

Plaque Psoriasis

Keywords

IL-23, dermatology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

205 (Actual)

8. Arms, Groups, and Interventions

Arm Title

30 mg Mirikizumab

Arm Type

Experimental

Arm Description

30 mg Mirikizumab administered subcutaneously (SC) every 8 weeks (Q8W).

Arm Title

100 mg Mirikizumab

Arm Type

Experimental

Arm Description

100 mg Mirikizumab administered SC Q8W.

Arm Title

300 mg Mirikizumab

Arm Type

Experimental

Arm Description

300 mg Mirikizumab administered SC Q8W.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC Q8W.

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 ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

Description

Time Frame

Week 16

Title

Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

Description

Time Frame

Week 16

Title

Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1

Description

Time Frame

Week 16

Title

Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score

Description

Time Frame

Baseline, Week 16

Title

Mean Change (Improvement) From Baseline on the Patient Global Assessment

Description

Time Frame

Baseline, Week 16

Title

Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score

Description

Time Frame

Baseline, Week 16

Title

Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

Description

Time Frame

Baseline, Week 16

Title

Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104

Description

Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104

Time Frame

Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 52, Week 56, Week 64, Week 72, Week 80, Week 88, Week 96, Week 100, Week 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline sPGA score of ≥3 at screening and baseline Candidate for biologic treatment for psoriasis. Exclusion Criteria: Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data. Breastfeeding or nursing (lactating) women. Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to 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 8 weeks prior to baseline. Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).

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

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Forward Clinical Trials, Inc

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

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

DS Research

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Dr. Shondra Smith MD

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70605

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

Oregon Dermatology and Research Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Clinical Partners LLC

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Menter Dermatology Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Dermatology Associates

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Calgary

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

City

Halifax

ZIP/Postal Code

B3H1Z2

Country

Canada

Facility Name

City

Montreal

ZIP/Postal Code

H2K4L5

Country

Canada

Facility Name

City

Peterborough

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

City

Richmond Hill

ZIP/Postal Code

L4B 1A5

Country

Canada

Facility Name

City

Waterloo

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

City

Gifu

ZIP/Postal Code

501-1194

Country

Japan

Facility Name

City

Kurume

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

City

Morioka

ZIP/Postal Code

020-8505

Country

Japan

Facility Name

City

Nagoya

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

City

Shinagawa-KU

ZIP/Postal Code

141-8625

Country

Japan

Facility Name

City

Shinjuku-ku

ZIP/Postal Code

169-0073

Country

Japan

Facility Name

City

Takaoka-shi

ZIP/Postal Code

9330871

Country

Japan

Facility Name

City

Tsu-shi

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

City

Bialystok

ZIP/Postal Code

15-017

Country

Poland

Facility Name

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Facility Name

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

01-518

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

City

Wroclaw

ZIP/Postal Code

51-318

Country

Poland

Facility Name

Grupo Dermatologico de Carolina

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

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 of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis

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