A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis

Study Purpose

Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study will assess how safe and effective cedirogant (ABBV-157) is compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements are assessing disease activity in participants with plaque psoriasis. Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants will be put into 1 of 4 groups, called treatment arms and each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 200 adult participants with moderate to severe plaque psoriasis will be enrolled at approximately 45 sites. Participants will receive oral daily doses of cedirogant or placebo capsules for 16 weeks. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

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 - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.

Exclusion Criteria:

  • - Primary non-responders to previous anti-IL-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
  • - Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.

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.

NCT05044234
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 2
Lead Sponsor

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

AbbVie
Principal Investigator

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

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

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

Industry
Overall Status Recruiting
Countries Canada, Japan, United States
Conditions

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

Psoriasis
Arms & Interventions

Arms

Experimental: Arm 1: Cedirogant

Participants will receive cedirogant Dose A once daily.

Experimental: Arm 2: Cedirogant

Participants will receive cedirogant Dose B once daily.

Experimental: Arm 3: Cedirogant

Participants will receive cedirogant Dose C once daily.

Placebo Comparator: Arm 4: Placebo

Participants will receive placebo once daily.

Interventions

Drug: - Cedirogant

Capsule, Oral

Drug: - Placebo

Capsule, Oral

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.

Birmingham, Alabama

Status

Active, not recruiting

Address

UAB Department of Dermatology /ID# 238563

Birmingham, Alabama, 35233

Phoenix, Arizona

Status

Active, not recruiting

Address

Medical Dermatology Specialist /ID# 238518

Phoenix, Arizona, 85006-2722

Arkansas Research Trials /ID# 238687, North Little Rock, Arkansas

Status

Active, not recruiting

Address

Arkansas Research Trials /ID# 238687

North Little Rock, Arkansas, 72117

Encino Research Center /ID# 245950, Encino, California

Status

Active, not recruiting

Address

Encino Research Center /ID# 245950

Encino, California, 91436

North Hollywood, California

Status

Active, not recruiting

Address

Velocity Clinical Research, Inc. /ID# 239536

North Hollywood, California, 91606

Medderm Associates /ID# 238834, San Diego, California

Status

Active, not recruiting

Address

Medderm Associates /ID# 238834

San Diego, California, 92103

Lakes Research, LLC /ID# 238831, Miami, Florida

Status

Active, not recruiting

Address

Lakes Research, LLC /ID# 238831

Miami, Florida, 33014

Miami, Florida

Status

Active, not recruiting

Address

Florida International Rsrch cr /ID# 245959

Miami, Florida, 33173

Sweetwater, Florida

Status

Active, not recruiting

Address

Lenus Research & Medical Group /ID# 238695

Sweetwater, Florida, 33172

Tampa, Florida

Status

Active, not recruiting

Address

Advanced Clinical Research Institute /ID# 238697

Tampa, Florida, 33607-6429

Tampa, Florida

Status

Active, not recruiting

Address

Clinical Research Trials of Florida, Inc. /ID# 238709

Tampa, Florida, 33607

ForCare Clinical Research /ID# 238856, Tampa, Florida

Status

Active, not recruiting

Address

ForCare Clinical Research /ID# 238856

Tampa, Florida, 33613-1244

Dawsonville, Georgia

Status

Active, not recruiting

Address

Cleaver Medical Group Dermatology - Dawsonville /ID# 246327

Dawsonville, Georgia, 30534-6369

Marietta, Georgia

Status

Active, not recruiting

Address

Marietta Dermatology Clinical Research /ID# 238679

Marietta, Georgia, 30060-1047

Arlington Dermatology /ID# 238701, Rolling Meadows, Illinois

Status

Active, not recruiting

Address

Arlington Dermatology /ID# 238701

Rolling Meadows, Illinois, 60008

Dawes Fretzin, LLC /ID# 238704, Indianapolis, Indiana

Status

Active, not recruiting

Address

Dawes Fretzin, LLC /ID# 238704

Indianapolis, Indiana, 46256

Tulane University /ID# 238859, New Orleans, Louisiana

Status

Active, not recruiting

Address

Tulane University /ID# 238859

New Orleans, Louisiana, 70112-2699

Caledonia, Michigan

Status

Active, not recruiting

Address

Derm Institute of West Michigan /ID# 247341

Caledonia, Michigan, 49316-7478

Edina, Minnesota

Status

Recruiting

Address

Zel Skin & Laser Specialists - Edina /ID# 238714

Edina, Minnesota, 55424-1200

Skin Specialists, PC /ID# 238514, Omaha, Nebraska

Status

Active, not recruiting

Address

Skin Specialists, PC /ID# 238514

Omaha, Nebraska, 68144

Kew Gardens, New York

Status

Recruiting

Address

Forest Hills Dermatology Group /ID# 238708

Kew Gardens, New York, 11415

Buffalo Medical Group /ID# 239068, Williamsville, New York

Status

Recruiting

Address

Buffalo Medical Group /ID# 239068

Williamsville, New York, 14221

Darst Dermatology /ID# 238677, Charlotte, North Carolina

Status

Active, not recruiting

Address

Darst Dermatology /ID# 238677

Charlotte, North Carolina, 28277

Wilmington, North Carolina

Status

Active, not recruiting

Address

Wilmington Dermatology Center /ID# 246445

Wilmington, North Carolina, 28403

Univ Hosp Cleveland /ID# 245953, Cleveland, Ohio

Status

Active, not recruiting

Address

Univ Hosp Cleveland /ID# 245953

Cleveland, Ohio, 44106

Mason, Ohio

Status

Active, not recruiting

Address

Dermatologists of Southwest Ohio, Inc /ID# 238939

Mason, Ohio, 45040-4520

Portland, Oregon

Status

Active, not recruiting

Address

Oregon Dermatology and Research Center /ID# 238823

Portland, Oregon, 97210

University of Pittsburgh MC /ID# 246170, Pittsburgh, Pennsylvania

Status

Active, not recruiting

Address

University of Pittsburgh MC /ID# 246170

Pittsburgh, Pennsylvania, 15260

Clinical Partners, LLC /ID# 238620, Johnston, Rhode Island

Status

Active, not recruiting

Address

Clinical Partners, LLC /ID# 238620

Johnston, Rhode Island, 02919

Charleston, South Carolina

Status

Active, not recruiting

Address

Clinical Research Center of the Carolinas /ID# 238827

Charleston, South Carolina, 29407

Health Concepts /ID# 238510, Rapid City, South Dakota

Status

Active, not recruiting

Address

Health Concepts /ID# 238510

Rapid City, South Dakota, 57702

Nashville, Tennessee

Status

Active, not recruiting

Address

Tennessee Clinical Research Center /ID# 238682

Nashville, Tennessee, 37215-2885

Arlington, Texas

Status

Active, not recruiting

Address

Arlington Research Center, Inc /ID# 244171

Arlington, Texas, 76011

Orion Clinical Research /ID# 238619, Austin, Texas

Status

Recruiting

Address

Orion Clinical Research /ID# 238619

Austin, Texas, 78759-4100

Bellaire Dermatology /ID# 247865, Bellaire, Texas

Status

Active, not recruiting

Address

Bellaire Dermatology /ID# 247865

Bellaire, Texas, 77401

Houston, Texas

Status

Active, not recruiting

Address

Center for Clinical Studies - Houston (Binz) /ID# 243700

Houston, Texas, 77004-8097

San Antonio, Texas

Status

Active, not recruiting

Address

Progressive Clinical Research /ID# 238565

San Antonio, Texas, 78229

Spokane, Washington

Status

Active, not recruiting

Address

Dermatology Specialists of Spokane /ID# 238809

Spokane, Washington, 99202

West Virginia Research /ID# 238517, Morgantown, West Virginia

Status

Active, not recruiting

Address

West Virginia Research /ID# 238517

Morgantown, West Virginia, 26505-0589

International Sites

Surrey, British Columbia, Canada

Status

Active, not recruiting

Address

Dr. Chih-ho Hong Medical Inc. /ID# 238864

Surrey, British Columbia, V3R 6A7

Wiseman Dermatology Research /ID# 238867, Winnipeg, Manitoba, Canada

Status

Active, not recruiting

Address

Wiseman Dermatology Research /ID# 238867

Winnipeg, Manitoba, R3M 3Z4

Barrie, Ontario, Canada

Status

Active, not recruiting

Address

SimcoDerm Medical and Surgical Dermatology Center /ID# 238861

Barrie, Ontario, L4M 7G1

London, Ontario, Canada

Status

Active, not recruiting

Address

Dr. Wei Jing Loo Medicine Prof /ID# 238865

London, Ontario, N6H 5L5

Lynderm Research Inc. /ID# 243199, Markham, Ontario, Canada

Status

Active, not recruiting

Address

Lynderm Research Inc. /ID# 243199

Markham, Ontario, L3P 1X2

K. Papp Clinical Research /ID# 239695, Waterloo, Ontario, Canada

Status

Active, not recruiting

Address

K. Papp Clinical Research /ID# 239695

Waterloo, Ontario, N2J 1C4

Nagoya shi, Aichi, Japan

Status

Recruiting

Address

Nagoya City University Hospital /ID# 239286

Nagoya shi, Aichi, 467-8602

Takagi Dermatology Clinic /ID# 239274, Obihiro-shi, Hokkaido, Japan

Status

Recruiting

Address

Takagi Dermatology Clinic /ID# 239274

Obihiro-shi, Hokkaido, 080-0013

JR Sapporo Hospital /ID# 239277, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

JR Sapporo Hospital /ID# 239277

Sapporo-shi, Hokkaido, 060-0033

Mie University Hospital /ID# 239275, Tsu-shi, Mie, Japan

Status

Recruiting

Address

Mie University Hospital /ID# 239275

Tsu-shi, Mie, 514-8507

Okayama University Hospital /ID# 239285, Okayama-shi, Okayama, Japan

Status

Recruiting

Address

Okayama University Hospital /ID# 239285

Okayama-shi, Okayama, 700-8558

Hirakata-shi, Osaka, Japan

Status

Recruiting

Address

Kansai Medical University Hospital /ID# 239278

Hirakata-shi, Osaka, 573-1191

Hamamatsu-shi, Shizuoka, Japan

Status

Recruiting

Address

Hamamatsu University Hospital /ID# 239346

Hamamatsu-shi, Shizuoka, 431-3192

Minato-ku, Tokyo, Japan

Status

Recruiting

Address

The Jikei University Hospital /ID# 239319

Minato-ku, Tokyo, 105-8471

NTT Medical Center Tokyo /ID# 239287, Shinagawa-ku, Tokyo, Japan

Status

Recruiting

Address

NTT Medical Center Tokyo /ID# 239287

Shinagawa-ku, Tokyo, 141-8625

Shinjuku-ku, Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical University Hospital /ID# 239320

Shinjuku-ku, Tokyo, 160-0023

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