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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03482011
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany, Japan, Korea, Republic of, Mexico, Poland, Puerto Rico, Russian Federation, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Univ of Connecticut, Farmington, Connecticut

Status

Recruiting

Address

Univ of Connecticut

Farmington, Connecticut, 06032

Site Contact

860-679-4600

Florida Academic Dermatology Centers, Coral Gables, Florida

Status

Recruiting

Address

Florida Academic Dermatology Centers

Coral Gables, Florida, 33134

Site Contact

305-324-2110

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

Site Contact

352-629-5800

Forward Clinical Trials, Inc, Tampa, Florida

Status

Recruiting

Address

Forward Clinical Trials, Inc

Tampa, Florida, 33624

Site Contact

813-960-2400

Arlington Dermatology, Rolling Meadows, Illinois

Status

Recruiting

Address

Arlington Dermatology

Rolling Meadows, Illinois, 60008

Site Contact

847-392-5440

The South Bend Clinic, South Bend, Indiana

Status

Recruiting

Address

The South Bend Clinic

South Bend, Indiana, 46617

Site Contact

574-204-6432

Oregon Medical Research Center, Portland, Oregon

Status

Recruiting

Address

Oregon Medical Research Center

Portland, Oregon, 97223

Site Contact

503-245-1525

Dermatology and Skin Surgery Center, Exton, Pennsylvania

Status

Recruiting

Address

Dermatology and Skin Surgery Center

Exton, Pennsylvania, 19341

Site Contact

610-594-6660

University of Utah MidValley Dematology, Murray, Utah

Status

Recruiting

Address

University of Utah MidValley Dematology

Murray, Utah, 84107

Site Contact

801-581-6465

Multicare Health System, Tacoma, Washington

Status

Recruiting

Address

Multicare Health System

Tacoma, Washington, 98405

Site Contact

253-572-2842

International Sites

Seibo Hospital, Shinjuku-ku, Tokyo, Japan

Status

Active, not recruiting

Address

Seibo Hospital

Shinjuku-ku, Tokyo, 161-8521

Site Contact

1-317-615-4559

Gemeinschaftspraxis Mahlow, Mahlow, Brandenburg, Germany

Status

Recruiting

Address

Gemeinschaftspraxis Mahlow

Mahlow, Brandenburg, 15831

Site Contact

49337939423

Universitätsklinikum Münster, Münster, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen, 48149

Site Contact

492518356558

Praxis Gerlach, Dresden, Sachsen, Germany

Status

Recruiting

Address

Praxis Gerlach

Dresden, Sachsen, 01097

Site Contact

491712383746

Charité Universitätsmedizin Berlin, Berlin, Germany

Status

Recruiting

Address

Charité Universitätsmedizin Berlin

Berlin, , 10117

Site Contact

4930450618333

ISA GmbH, Berlin, Germany

Status

Recruiting

Address

ISA GmbH

Berlin, , 10789

Site Contact

49307812128

Universitätsklinikum Hamburg - Eppendorf, Hamburg, Germany

Status

Recruiting

Address

Universitätsklinikum Hamburg - Eppendorf

Hamburg, , 20246

Site Contact

4940741058681

Clinical Research Hamburg GmbH, Hamburg, Germany

Status

Recruiting

Address

Clinical Research Hamburg GmbH

Hamburg, , 22143

Site Contact

49406312970

Sakura, Chiba, Japan

Status

Active, not recruiting

Address

Toho University School of Medicine, Sakura Hospital

Sakura, Chiba, 285-8741

Site Contact

1-317-615-4559

Takagi Dermatological Clinic, Obihiro, Hokkaido, Japan

Status

Active, not recruiting

Address

Takagi Dermatological Clinic

Obihiro, Hokkaido, 080-0013

Site Contact

1-317-615-4559

Kanto Rosai Hospital, Kawasaki, Kanagawa, Japan

Status

Active, not recruiting

Address

Kanto Rosai Hospital

Kawasaki, Kanagawa, 211-8510

Site Contact

1-317-615-4559

Yokohama City University Hospital, Yokohama, Kanagawa, Japan

Status

Active, not recruiting

Address

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004

Site Contact

1-317-615-4559

Ryukyu University Hospital, Nakagami-gun, Okinawa, Japan

Status

Active, not recruiting

Address

Ryukyu University Hospital

Nakagami-gun, Okinawa, 903-0215

Site Contact

1-317-615-4559

Kume Clinic, Nishi-ku Sakai-shi, Osaka, Japan

Status

Active, not recruiting

Address

Kume Clinic

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

Site Contact

1-317-615-4559

Shimane University Hospital, Izumo, Shimane, Japan

Status

Active, not recruiting

Address

Shimane University Hospital

Izumo, Shimane, 693-8501

Site Contact

1-317-615-4559

Hachioji, Tokyo, Japan

Status

Active, not recruiting

Address

Tokyo Medical University Hachioji Medical Center

Hachioji, Tokyo, 193-0998

Site Contact

1-317-615-4559

NTT Medical Center Tokyo, Shinagawa-KU, Tokyo, Japan

Status

Active, not recruiting

Address

NTT Medical Center Tokyo

Shinagawa-KU, Tokyo, 141-8625

Site Contact

1-317-615-4559

Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan

Status

Active, not recruiting

Address

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023

Site Contact

1-317-615-4559

Shirasaki Clinic, Takaoka-shi, Toyama, Japan

Status

Active, not recruiting

Address

Shirasaki Clinic

Takaoka-shi, Toyama, 9330871

Site Contact

1-317-615-4559

Bucheon St. Mary's Hospital, Bucheon,, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Bucheon St. Mary's Hospital

Bucheon,, Gyeonggi-do, 14647

Site Contact

821091951799

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

Status

Recruiting

Address

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620

Site Contact

1-317-615-4559

Bundang CHA General Hospital, Sungnam-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Bundang CHA General Hospital

Sungnam-si, Gyeonggi-do, 13496

Site Contact

82317805240

Ajou University Hospital, Suwon, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Ajou University Hospital

Suwon, Gyeonggi-do, 16499

Site Contact

82312194466

Kyung Hee University Hospital, Seoul, Korea, Korea, Republic of

Status

Recruiting

Address

Kyung Hee University Hospital

Seoul, Korea, 02447

Site Contact

821091544113

Korea University Guro Hospital, Seoul, Korea, Korea, Republic of

Status

Recruiting

Address

Korea University Guro Hospital

Seoul, Korea, 08308

Site Contact

82226263195

Ulsan University Hospital, Ulsan, Korea, Korea, Republic of

Status

Recruiting

Address

Ulsan University Hospital

Ulsan, Korea, 44033

Site Contact

82522507090

Chungnam National University Hospital, Daejeon, Korea, Republic of

Status

Recruiting

Address

Chungnam National University Hospital

Daejeon, , 35015

Site Contact

82422807707

Chonnam National University Hospital, Gwangju, Korea, Republic of

Status

Recruiting

Address

Chonnam National University Hospital

Gwangju, , 61469

Site Contact

821046029663

Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital Yonsei University Health System

Seoul, , 03722

Site Contact

82-2-2228-2085

Hanyang University Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Hanyang University Medical Center

Seoul, , 04763

Site Contact

82222908441

Konkuk University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Konkuk University Hospital

Seoul, , 05030

Site Contact

82220305172

Centro Medico del Angel S.C., Mexicali, Baja California, Mexico

Status

Recruiting

Address

Centro Medico del Angel S.C.

Mexicali, Baja California, 21100

Site Contact

526865529404

Hospital de Jesus, Mexico City, Distrito Federal, Mexico

Status

Recruiting

Address

Hospital de Jesus

Mexico City, Distrito Federal, 06090

Site Contact

5215555223312

Zapopan, Jalisco, Mexico

Status

Recruiting

Address

Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio

Zapopan, Jalisco, 45190

Site Contact

523312022163

Morella, Michoacan, Mexico

Status

Recruiting

Address

Clínica Enfermedades Crónicas y Procedimientos Especiales SC

Morella, Michoacan, 58249

Site Contact

524433232828

B&B Investigaciones Medicas, SC, Mazatlan, Sinaloa, Mexico

Status

Recruiting

Address

B&B Investigaciones Medicas, SC

Mazatlan, Sinaloa, 82140

Site Contact

526691120808

Kohler Milstein Research, S.A. de C.V., Merida, Yucatan, Mexico

Status

Recruiting

Address

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

Merida, Yucatan, 97070

Site Contact

529999204004

RM Pharma Specialists S.A. de C.V., Distrito Federal, Mexico

Status

Recruiting

Address

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

Distrito Federal, , 3100

Site Contact

525565501629

Durango, Mexico

Status

Recruiting

Address

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, , 34000

Site Contact

526181963882

NZOZ ZDROWIE Osteo-Medic, Bialystok, Poland

Status

Recruiting

Address

NZOZ ZDROWIE Osteo-Medic

Bialystok, , 15-351

Site Contact

48604220748

"Dermed" Centrum Medyczne Sp. z o.o., Lodz, Poland

Status

Recruiting

Address

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

Lodz, , 90-265

Site Contact

48426631444

Lubelskie Centrum Diagnostyczne, Swidnik, Poland

Status

Recruiting

Address

Lubelskie Centrum Diagnostyczne

Swidnik, , 21-040

Site Contact

48509678110

Centrum Medyczne AMED, Warszawa, Poland

Status

Recruiting

Address

Centrum Medyczne AMED

Warszawa, , 01-518

Site Contact

48224004041

DermMEDICA Sp. z o.o., Wroclaw, Poland

Status

Recruiting

Address

DermMEDICA Sp. z o.o.

Wroclaw, , 51-318

Site Contact

48501425260

Office of Dr. Alma M. Cruz, Carolina, Puerto Rico

Status

Recruiting

Address

Office of Dr. Alma M. Cruz

Carolina, , 00985

Site Contact

7877691954

GCM Medical Group PSC, San Juan, Puerto Rico

Status

Recruiting

Address

GCM Medical Group PSC

San Juan, , 00909

Site Contact

7877268396

Krasnodar, Russian Federation

Status

Recruiting

Address

GBUZ Clinical dermatology and venereological dispensary

Krasnodar, , 350000

Site Contact

78612552166

Moscow, Russian Federation

Status

Recruiting

Address

State scientific centre for dermatovenerology and cosmetolog

Moscow, , 107076

Site Contact

84997852083

Moscow, Russian Federation

Status

Recruiting

Address

First Moscow State Medical University n.a. Sechenov

Moscow, , 119991

Site Contact

84992480181

Smolensk, Russian Federation

Status

Recruiting

Address

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

Smolensk, , 214000

Site Contact

84812555083

SPb SBHI Skin-venerologic dispensary #10, St. Petersburg, Russian Federation

Status

Recruiting

Address

SPb SBHI Skin-venerologic dispensary #10

St. Petersburg, , 194021

Site Contact

78126705070

Tver State Medical University, Tver, Russian Federation

Status

Recruiting

Address

Tver State Medical University

Tver, , 170100

Site Contact

74822321779

National Taiwan University Hospital, Taipei City, Zhongzheng District, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei City, Zhongzheng District, 100

Site Contact

886972651561

Hsinchu, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital Hsin-Chu

Hsinchu, , 30059

Site Contact

88635326151

Chang Gung Memorial Hospital - Kaohsiung, Kaohsiung, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung, , 83301

Site Contact

88677317123

New Taipei City, Taiwan

Status

Recruiting

Address

Taipei Medical University- Shuang Ho Hospital

New Taipei City, , 23561

Site Contact

886222492388

Chung Shan Medical University Hospital, Taichung City, Taiwan

Status

Recruiting

Address

Chung Shan Medical University Hospital

Taichung City, , 40201

Site Contact

886975128095

National Cheng Kung University Hospital, Tainan, Taiwan

Status

Recruiting

Address

National Cheng Kung University Hospital

Tainan, , 70403

Site Contact

88662353535

Chang Gung Memorial Hospital - Linkou, Taoyuan Hsien, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital - Linkou

Taoyuan Hsien, , 10508

Site Contact

886975360157

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