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

NCT03482011 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 16505I6T-MC-AMAK2017-003298-32
• Study Type: interventional
• Target: 530
• Locations: 9 countries
• Sites: 69

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.

Conditions

Psoriasis

Keywords

Psoriasis; IL-23

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 16

• 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).

  Week 16

Secondary Outcomes (17)

• Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)

  Week 4

• Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)

  Week 16

• Percentage of Participants Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100)

  Week 16

• Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement

  Week 16

• Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥1 at Baseline

  Week 16

Study Arms (2)

Mirikizumab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Mirikizumab DRUG

Administered SC

Also known as: LY3074828

Mirikizumab

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (69)

Univ of Connecticut

Farmington, Connecticut, 06032, United States

Location

Florida Academic Dermatology Centers

Coral Gables, Florida, 33134, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Forward Clinical Trials, Inc

Tampa, Florida, 33624, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Dermatology and Skin Surgery Center

Exton, Pennsylvania, 19341, United States

Location

University of Utah MidValley Dematology

Murray, Utah, 84107, United States

Location

Multicare Health System

Tacoma, Washington, 98405, United States

Location

Gemeinschaftspraxis Mahlow

Mahlow, Brandenburg, 15831, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Praxis Gerlach

Dresden, Saxony, 01097, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

ISA GmbH

Berlin, 10789, Germany

Location

Universitätsklinikum Hamburg - Eppendorf

Hamburg, 20246, Germany

Location

Clinical Research Hamburg GmbH

Hamburg, 22143, Germany

Location

Toho University School of Medicine, Sakura Hospital

Sakura, Chiba, 285-8741, Japan

Location

Takagi Dermatological Clinic

Obihiro, Hokkaido, 080-0013, Japan

Location

Kanto Rosai Hospital

Kawasaki, Kanagawa, 211-8510, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Ryukyu University Hospital

Nakagami-gun, Okinawa, 903-0215, Japan

Location

Kume Clinic

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

Location

Shimane University Hospital

Izumo, Shimane, 693-8501, Japan

Location

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, 193-0998, Japan

Location

NTT Medical Center Tokyo

Shinagawa-KU, Tokyo, 141-8625, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Seibo Hospital

Shinjuku-ku, Tokyo, 161-8521, Japan

Location

Shirasaki Clinic

Takaoka-shi, Toyama, 9330871, Japan

Location

Centro Medico del Angel S.C.

Mexicali, Estado de Baja California, 21100, Mexico

Location

Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio

Zapopan, Jalisco, 45190, Mexico

Location

Hospital de Jesus

Mexico City, Mexico City, 06090, Mexico

Location

Clínica Enfermedades Crónicas y Procedimientos Especiales SC

Morella, Michoacán, 58249, Mexico

Location

B&B Investigaciones Medicas, SC

Mazatlán, Sinaloa, 82140, Mexico

Location

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

Mérida, Yucatán, 97070, Mexico

Location

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

Distrito Federal, 3100, Mexico

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, 34000, Mexico

Location

NZOZ ZDROWIE Osteo-Medic

Bialystok, 15-351, Poland

Location

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

Lodz, 90-265, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Location

Centrum Medyczne AMED

Warsaw, 01-518, Poland

Location

DermMEDICA Sp. z o.o.

Wroclaw, 51-318, Poland

Location

Office of Dr. Alma M. Cruz

Carolina, PR, 00985, Puerto Rico

Location

GCM Medical Group PSC

San Juan, PR, 00909, Puerto Rico

Location

GBUZ Clinical dermatology and venereological dispensary

Krasnodar, 350000, Russia

Location

State scientific centre for dermatovenerology and cosmetolog

Moscow, 107076, Russia

Location

First Moscow State Medical University n.a. Sechenov

Moscow, 119991, Russia

Location

SPb SBHI Skin-venerologic dispensary #10

Saint Petersburg, 194021, Russia

Location

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

Smolensk, 214000, Russia

Location

Tver State Medical University

Tver', 170100, Russia

Location

Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Bundang CHA General Hospital

Sungnam-si, Gyeonggi-do, 13496, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Kyung Hee University Hospital

Seoul, Korea, 02447, South Korea

Location

Korea University Guro Hospital

Seoul, Korea, 08308, South Korea

Location

Ulsan University Hospital

Ulsan, Korea, 44033, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Hanyang University Medical Center

Seoul, 04763, South Korea

Location

Konkuk University Hospital

Seoul, 05030, South Korea

Location

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

Location

National Taiwan University Hospital Hsin-Chu

Hsinchu, 30059, Taiwan

Location

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, 83301, Taiwan

Location

Taipei Medical University- Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan Hsien, 10508, Taiwan

Location

Related Publications (1)

• Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.

  PMID: 39073712 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 29, 2018
• Study Start: April 24, 2018
• Primary Completion: March 21, 2019
• Study Completion: January 16, 2020
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-02-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

RU (6); US (10); KR (12); PL (5); TW (7); JP (12); ME (8); DE (7); PR (2)