A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
- Registration Number
- NCT05044234
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 156
- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks. 75 mg Cedirogant Cedirogant Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks. 150 mg Cedirogant Cedirogant Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. 375 mg Cedirogant Cedirogant Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 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.
Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16 Baseline, 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.
Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16 Baseline, 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.
Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16 Baseline, 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.
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 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.
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 Baseline, Week 16 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."
Trial Locations
- Locations (53)
West Virginia Research /ID# 238517
🇺🇸Morgantown, West Virginia, United States
Lenus Research & Medical Group /ID# 238695
🇺🇸Sweetwater, Florida, United States
Mie University Hospital /ID# 239275
🇯🇵Tsu-shi, Mie, Japan
Encino Research Center /ID# 245950
🇺🇸Encino, California, United States
Cleaver Medical Group Dermatology - Dawsonville /ID# 246327
🇺🇸Dawsonville, Georgia, United States
Velocity Clinical Research, Inc. /ID# 239536
🇺🇸North Hollywood, California, United States
Univ Hosp Cleveland /ID# 245953
🇺🇸Cleveland, Ohio, United States
Dermatologists of Southwest Ohio, Inc /ID# 238939
🇺🇸Mason, Ohio, United States
University of Pittsburgh MC /ID# 246170
🇺🇸Pittsburgh, Pennsylvania, United States
Arlington Research Center, Inc /ID# 244171
🇺🇸Arlington, Texas, United States
Orion Clinical Research /ID# 238619
🇺🇸Austin, Texas, United States
Clinical Partners, LLC /ID# 238620
🇺🇸Johnston, Rhode Island, United States
Medderm Associates /ID# 238834
🇺🇸San Diego, California, United States
Lakes Research, LLC /ID# 238831
🇺🇸Miami, Florida, United States
Florida International Rsrch cr /ID# 245959
🇺🇸Miami, Florida, United States
Tennessee Clinical Research Center /ID# 238682
🇺🇸Nashville, Tennessee, United States
Progressive Clinical Research /ID# 238565
🇺🇸San Antonio, Texas, United States
Marietta Dermatology Clinical Research /ID# 238679
🇺🇸Marietta, Georgia, United States
Arlington Dermatology /ID# 238701
🇺🇸Rolling Meadows, Illinois, United States
Zel Skin & Laser Specialists - Edina /ID# 238714
🇺🇸Edina, Minnesota, United States
Dawes Fretzin, LLC /ID# 238704
🇺🇸Indianapolis, Indiana, United States
Darst Dermatology /ID# 238677
🇺🇸Charlotte, North Carolina, United States
Forest Hills Dermatology Group /ID# 238708
🇺🇸Kew Gardens, New York, United States
Buffalo Medical Group /ID# 239068
🇺🇸Williamsville, New York, United States
Wilmington Dermatology Center /ID# 246445
🇺🇸Wilmington, North Carolina, United States
Bellaire Dermatology Associates /ID# 247865
🇺🇸Bellaire, Texas, United States
Center for Clinical Studies - Houston (Binz) /ID# 243700
🇺🇸Houston, Texas, United States
Dermatology Specialists of Spokane /ID# 238809
🇺🇸Spokane, Washington, United States
Dr. Chih-ho Hong Medical Inc. /ID# 238864
🇨🇦Surrey, British Columbia, Canada
SimcoDerm Medical and Surgical Dermatology Center /ID# 238861
🇨🇦Barrie, Ontario, Canada
Lynderm Research Inc. /ID# 243199
🇨🇦Markham, Ontario, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 238865
🇨🇦London, Ontario, Canada
K. Papp Clinical Research /ID# 239695
🇨🇦Waterloo, Ontario, Canada
Nagoya City University Hospital /ID# 239286
🇯🇵Nagoya shi, Aichi, Japan
Takagi Dermatology Clinic /ID# 239274
🇯🇵Obihiro-shi, Hokkaido, Japan
JR Sapporo Hospital /ID# 239277
🇯🇵Sapporo-shi, Hokkaido, Japan
Okayama University Hospital /ID# 239285
🇯🇵Okayama-shi, Okayama, Japan
Kansai Medical University Hospital /ID# 239278
🇯🇵Hirakata-shi, Osaka, Japan
Hamamatsu University Hospital /ID# 239346
🇯🇵Hamamatsu-shi, Shizuoka, Japan
NTT Medical Center Tokyo /ID# 239287
🇯🇵Shinagawa-ku, Tokyo, Japan
The Jikei University Hospital /ID# 239319
🇯🇵Minato-ku, Tokyo, Japan
Wiseman Dermatology Research /ID# 238867
🇨🇦Winnipeg, Manitoba, Canada
UAB Department of Dermatology /ID# 238563
🇺🇸Birmingham, Alabama, United States
Medical Dermatology Specialist /ID# 238518
🇺🇸Phoenix, Arizona, United States
Oregon Dermatology and Research Center /ID# 238823
🇺🇸Portland, Oregon, United States
Arkansas Research Trials, LLC /ID# 238687
🇺🇸North Little Rock, Arkansas, United States
Health Concepts /ID# 238510
🇺🇸Rapid City, South Dakota, United States
Tokyo Medical University Hospital /ID# 239320
🇯🇵Shinjuku-ku, Tokyo, Japan
Advanced Clinical Research Institute /ID# 238697
🇺🇸Tampa, Florida, United States
ForCare Clinical Research /ID# 238856
🇺🇸Tampa, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 238709
🇺🇸Tampa, Florida, United States
Skin Specialists, PC /ID# 238514
🇺🇸Omaha, Nebraska, United States
Clinical Research Center of the Carolinas /ID# 238827
🇺🇸Charleston, South Carolina, United States