Clinical trial NCT05044234: A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Cedirogant
ABBV-157
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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-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.

Primary outcomes:
measure: Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
timeFrame: At Week 16
measure: Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline
timeFrame: Baseline, Week 16
measure: 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
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Dermatology /ID# 238563
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialist /ID# 238518
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Research Trials, LLC /ID# 238687
state: Arkansas
city: Encino
country: United States
facility: Encino Research Center /ID# 245950
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, Inc. /ID# 239536
state: California
city: San Diego
country: United States
facility: Medderm Associates /ID# 238834
state: California
city: Miami
country: United States
facility: Lakes Research, LLC /ID# 238831
state: Florida
city: Miami
country: United States
facility: Florida International Rsrch cr /ID# 245959
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group /ID# 238695
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute /ID# 238697
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc. /ID# 238709
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 238856
state: Florida
city: Dawsonville
country: United States
facility: Cleaver Medical Group Dermatology - Dawsonville /ID# 246327
state: Georgia
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research /ID# 238679
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 238701
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 238704
state: Indiana
city: Edina
country: United States
facility: Zel Skin & Laser Specialists - Edina /ID# 238714
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC /ID# 238514
state: Nebraska
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group /ID# 238708
state: New York
city: Williamsville
country: United States
facility: Buffalo Medical Group /ID# 239068
state: New York
city: Charlotte
country: United States
facility: Darst Dermatology /ID# 238677
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 246445
state: North Carolina
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 245953
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio, Inc /ID# 238939
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center /ID# 238823
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 246170
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC /ID# 238620
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas /ID# 238827
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts /ID# 238510
state: South Dakota
city: Nashville
country: United States
facility: Tennessee Clinical Research Center /ID# 238682
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 244171
state: Texas
city: Austin
country: United States
facility: Orion Clinical Research /ID# 238619
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 247865
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 243700
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research /ID# 238565
state: Texas
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane /ID# 238809
state: Washington
city: Morgantown
country: United States
facility: West Virginia Research /ID# 238517
state: West Virginia
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 238864
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 238867
state: Manitoba
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center /ID# 238861
state: Ontario
city: London
country: Canada
facility: Dr. Wei Jing Loo Medicine Prof /ID# 238865
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc. /ID# 243199
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research /ID# 239695
state: Ontario
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 239286
state: Aichi
city: Obihiro-shi
country: Japan
facility: Takagi Dermatology Clinic /ID# 239274
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: JR Sapporo Hospital /ID# 239277
state: Hokkaido
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 239275
state: Mie
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 239285
state: Okayama
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 239278
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 239346
state: Shizuoka
city: Minato-ku
country: Japan
facility: The Jikei University Hospital /ID# 239319
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 239287
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 239320
state: Tokyo
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: