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

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis

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.

Study Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Cedirogant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc. /ID# 238864
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research /ID# 238867
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Center /ID# 238861
    • London, Ontario, Canada, N6H 5L5
      • Dr. Wei Jing Loo Medicine Prof /ID# 238865
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc. /ID# 243199
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research /ID# 239695
• Japan
  • Aichi
    • Nagoya shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital /ID# 239286
  • Hokkaido
    • Obihiro-shi, Hokkaido, Japan, 080-0013
      • Takagi Dermatology Clinic /ID# 239274
    • Sapporo-shi, Hokkaido, Japan, 060-0033
      • JR Sapporo Hospital /ID# 239277
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital /ID# 239275
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital /ID# 239285
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital /ID# 239278
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital /ID# 239346
  • Tokyo
    • Minato-ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital /ID# 239319
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • NTT Medical Center Tokyo /ID# 239287
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital /ID# 239320
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Department of Dermatology /ID# 238563
  • Arizona
    • Phoenix, Arizona, United States, 85006-2722
      • Medical Dermatology Specialist /ID# 238518
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials, LLC /ID# 238687
  • California
    • Encino, California, United States, 91436
      • Encino Research Center /ID# 245950
    • North Hollywood, California, United States, 91606
      • Velocity Clinical Research, Inc. /ID# 239536
    • San Diego, California, United States, 92103
      • Medderm Associates /ID# 238834
  • Florida
    • Miami, Florida, United States, 33014
      • Lakes Research, LLC /ID# 238831
    • Miami, Florida, United States, 33173
      • Florida International Rsrch cr /ID# 245959
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group /ID# 238695
    • Tampa, Florida, United States, 33607-6429
      • Advanced Clinical Research Institute /ID# 238697
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida, Inc. /ID# 238709
    • Tampa, Florida, United States, 33613-1244
      • ForCare Clinical Research /ID# 238856
  • Georgia
    • Dawsonville, Georgia, United States, 30534-6369
      • Cleaver Medical Group Dermatology - Dawsonville /ID# 246327
    • Marietta, Georgia, United States, 30060-1047
      • Marietta Dermatology Clinical Research /ID# 238679
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology /ID# 238701
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin, LLC /ID# 238704
  • Minnesota
    • Edina, Minnesota, United States, 55424-1200
      • Zel Skin & Laser Specialists - Edina /ID# 238714
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC /ID# 238514
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group /ID# 238708
    • Williamsville, New York, United States, 14221
      • Buffalo Medical Group /ID# 239068
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Darst Dermatology /ID# 238677
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center /ID# 246445
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland /ID# 245953
    • Mason, Ohio, United States, 45040-4520
      • Dermatologists of Southwest Ohio, Inc /ID# 238939
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center /ID# 238823
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 246170
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC /ID# 238620
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas /ID# 238827
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts /ID# 238510
  • Tennessee
    • Nashville, Tennessee, United States, 37215-2885
      • Tennessee Clinical Research Center /ID# 238682
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc /ID# 244171
    • Austin, Texas, United States, 78759-4100
      • Orion Clinical Research /ID# 238619
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates /ID# 247865
    • Houston, Texas, United States, 77004-8097
      • Center for Clinical Studies - Houston (Binz) /ID# 243700
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research /ID# 238565
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane /ID# 238809
  • West Virginia
    • Morgantown, West Virginia, United States, 26505-0589
      • West Virginia Research /ID# 238517

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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-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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	Drug: Placebo; Capsule, Oral
Experimental: 75 mg Cedirogant; Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	Drug: Cedirogant; Capsule, Oral; Other Names: ABBV-157
Experimental: 150 mg Cedirogant; Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	Drug: Cedirogant; Capsule, Oral; Other Names: ABBV-157
Placebo Comparator: 375 mg Cedirogant; Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.	Drug: Cedirogant; Capsule, Oral; Other Names: ABBV-157

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16	The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.	At Week 16
Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) 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 50 is defined as at least a 50% 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
Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) 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 90 is defined as at least a 90% 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
Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) 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 100 is defined as at least a 100% 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
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline	The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms.	Baseline, Week 16
Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline	The itch NRS is an 11-point scale that participants completed to describe the intensity of their itch using a 24-hour recall period. The itch NRS asked the participants to: "Please rate your itching severity due to your psoriasis by circling the number that best describes your worst level of itching in the past 24 hours?" The itch NRS scale scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable."	Baseline, Week 16

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Cedirogant; ABBV-157
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: M18-816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing 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/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes