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

NCT05044234 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: M18-816
• Study Type: interventional
• Target: 156
• Locations: 3 countries
• Sites: 53

Brief Summary

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

Conditions

Psoriasis

Keywords

Psoriasis; Plaque Psoriasis; Cedirogant; ABBV-157

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16

  The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

  Baseline, Week 16

Secondary Outcomes (6)

• Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16

  At Week 16

• Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16

  Baseline, Week 16

• Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16

  Baseline, Week 16

• Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16

  Baseline, Week 16

• Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline

  Baseline, Week 16

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.

Drug: Placebo

75 mg Cedirogant

EXPERIMENTAL

Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.

Drug: Cedirogant

150 mg Cedirogant

EXPERIMENTAL

Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.

Drug: Cedirogant

375 mg Cedirogant

PLACEBO COMPARATOR

Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.

Drug: Cedirogant

Interventions

Cedirogant DRUG

Capsule, Oral

Also known as: ABBV-157

150 mg Cedirogant; 375 mg Cedirogant; 75 mg Cedirogant

Placebo DRUG

Capsule, Oral

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Primary non-responders to previous anti-interleukin (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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (53)

UAB Department of Dermatology /ID# 238563

Birmingham, Alabama, 35233, United States

Location

Medical Dermatology Specialist /ID# 238518

Phoenix, Arizona, 85006-2722, United States

Location

Arkansas Research Trials, LLC /ID# 238687

North Little Rock, Arkansas, 72117, United States

Location

Encino Research Center /ID# 245950

Encino, California, 91436, United States

Location

Velocity Clinical Research, Inc. /ID# 239536

North Hollywood, California, 91606, United States

Location

Medderm Associates /ID# 238834

San Diego, California, 92103, United States

Location

Lakes Research, LLC /ID# 238831

Miami, Florida, 33014, United States

Location

Florida International Rsrch cr /ID# 245959

Miami, Florida, 33173, United States

Location

Lenus Research & Medical Group /ID# 238695

Sweetwater, Florida, 33172, United States

Location

Advanced Clinical Research Institute /ID# 238697

Tampa, Florida, 33607-6429, United States

Location

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

Tampa, Florida, 33607, United States

Location

ForCare Clinical Research /ID# 238856

Tampa, Florida, 33613-1244, United States

Location

Cleaver Medical Group Dermatology - Dawsonville /ID# 246327

Dawsonville, Georgia, 30534-6369, United States

Location

Marietta Dermatology Clinical Research /ID# 238679

Marietta, Georgia, 30060-1047, United States

Location

Arlington Dermatology /ID# 238701

Rolling Meadows, Illinois, 60008, United States

Location

Dawes Fretzin, LLC /ID# 238704

Indianapolis, Indiana, 46256, United States

Location

Zel Skin & Laser Specialists - Edina /ID# 238714

Edina, Minnesota, 55424-1200, United States

Location

Skin Specialists, PC /ID# 238514

Omaha, Nebraska, 68144, United States

Location

Forest Hills Dermatology Group /ID# 238708

Kew Gardens, New York, 11415, United States

Location

Buffalo Medical Group /ID# 239068

Williamsville, New York, 14221, United States

Location

Darst Dermatology /ID# 238677

Charlotte, North Carolina, 28277, United States

Location

Wilmington Dermatology Center /ID# 246445

Wilmington, North Carolina, 28403, United States

Location

Univ Hosp Cleveland /ID# 245953

Cleveland, Ohio, 44106, United States

Location

Dermatologists of Southwest Ohio, Inc /ID# 238939

Mason, Ohio, 45040-4520, United States

Location

Oregon Dermatology and Research Center /ID# 238823

Portland, Oregon, 97210, United States

Location

University of Pittsburgh MC /ID# 246170

Pittsburgh, Pennsylvania, 15260, United States

Location

Clinical Partners, LLC /ID# 238620

Johnston, Rhode Island, 02919, United States

Location

Clinical Research Center of the Carolinas /ID# 238827

Charleston, South Carolina, 29407, United States

Location

Health Concepts /ID# 238510

Rapid City, South Dakota, 57702, United States

Location

Tennessee Clinical Research Center /ID# 238682

Nashville, Tennessee, 37215-2885, United States

Location

Arlington Research Center, Inc /ID# 244171

Arlington, Texas, 76011, United States

Location

Orion Clinical Research /ID# 238619

Austin, Texas, 78759-4100, United States

Location

Bellaire Dermatology Associates /ID# 247865

Bellaire, Texas, 77401, United States

Location

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

Houston, Texas, 77004-8097, United States

Location

Progressive Clinical Research /ID# 238565

San Antonio, Texas, 78229, United States

Location

Dermatology Specialists of Spokane /ID# 238809

Spokane, Washington, 99202, United States

Location

West Virginia Research /ID# 238517

Morgantown, West Virginia, 26505-0589, United States

Location

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

Surrey, British Columbia, V3R 6A7, Canada

Location

Wiseman Dermatology Research /ID# 238867

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center /ID# 238861

Barrie, Ontario, L4M 7G1, Canada

Location

Dr. Wei Jing Loo Medicine Prof /ID# 238865

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc. /ID# 243199

Markham, Ontario, L3P 1X2, Canada

Location

K. Papp Clinical Research /ID# 239695

Waterloo, Ontario, N2J 1C4, Canada

Location

Nagoya City University Hospital /ID# 239286

Nagoya, Aichi-ken, 467-8602, Japan

Location

Takagi Dermatology Clinic /ID# 239274

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

JR Sapporo Hospital /ID# 239277

Sapporo, Hokkaido, 060-0033, Japan

Location

Mie University Hospital /ID# 239275

Tsu, Mie-ken, 514-8507, Japan

Location

Okayama University Hospital /ID# 239285

Okayama, Okayama-ken, 700-8558, Japan

Location

Kansai Medical University Hospital /ID# 239278

Hirakata-shi, Osaka, 573-1191, Japan

Location

Hamamatsu University Hospital /ID# 239346

Hamamatsu, Shizuoka, 431-3192, Japan

Location

The Jikei University Hospital /ID# 239319

Minato-ku, Tokyo, 105-8471, Japan

Location

NTT Medical Center Tokyo /ID# 239287

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Tokyo Medical University Hospital /ID# 239320

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 14, 2021
• Study Start: November 16, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (37); CA (6); JP (10)