A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
NCT ID: NCT05044234
Last Updated: 2023-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
156 participants
INTERVENTIONAL
2021-11-16
2022-11-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.
Placebo
Capsule, Oral
75 mg Cedirogant
Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.
Cedirogant
Capsule, Oral
150 mg Cedirogant
Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.
Cedirogant
Capsule, Oral
375 mg Cedirogant
Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Cedirogant
Capsule, Oral
Interventions
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Cedirogant
Capsule, Oral
Placebo
Capsule, Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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UAB Department of Dermatology /ID# 238563
Birmingham, Alabama, United States
Medical Dermatology Specialist /ID# 238518
Phoenix, Arizona, United States
Arkansas Research Trials, LLC /ID# 238687
North Little Rock, Arkansas, United States
Encino Research Center /ID# 245950
Encino, California, United States
Velocity Clinical Research, Inc. /ID# 239536
North Hollywood, California, 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
Lenus Research & Medical Group /ID# 238695
Sweetwater, Florida, United States
Advanced Clinical Research Institute /ID# 238697
Tampa, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 238709
Tampa, Florida, United States
ForCare Clinical Research /ID# 238856
Tampa, Florida, United States
Cleaver Medical Group Dermatology - Dawsonville /ID# 246327
Dawsonville, Georgia, United States
Marietta Dermatology Clinical Research /ID# 238679
Marietta, Georgia, United States
Arlington Dermatology /ID# 238701
Rolling Meadows, Illinois, United States
Dawes Fretzin, LLC /ID# 238704
Indianapolis, Indiana, United States
Zel Skin & Laser Specialists - Edina /ID# 238714
Edina, Minnesota, United States
Skin Specialists, PC /ID# 238514
Omaha, Nebraska, United States
Forest Hills Dermatology Group /ID# 238708
Kew Gardens, New York, United States
Buffalo Medical Group /ID# 239068
Williamsville, New York, United States
Darst Dermatology /ID# 238677
Charlotte, North Carolina, United States
Wilmington Dermatology Center /ID# 246445
Wilmington, North Carolina, United States
Univ Hosp Cleveland /ID# 245953
Cleveland, Ohio, United States
Dermatologists of Southwest Ohio, Inc /ID# 238939
Mason, Ohio, United States
Oregon Dermatology and Research Center /ID# 238823
Portland, Oregon, United States
University of Pittsburgh MC /ID# 246170
Pittsburgh, Pennsylvania, United States
Clinical Partners, LLC /ID# 238620
Johnston, Rhode Island, United States
Clinical Research Center of the Carolinas /ID# 238827
Charleston, South Carolina, United States
Health Concepts /ID# 238510
Rapid City, South Dakota, United States
Tennessee Clinical Research Center /ID# 238682
Nashville, Tennessee, United States
Arlington Research Center, Inc /ID# 244171
Arlington, Texas, United States
Orion Clinical Research /ID# 238619
Austin, Texas, United States
Bellaire Dermatology Associates /ID# 247865
Bellaire, Texas, United States
Center for Clinical Studies - Houston (Binz) /ID# 243700
Houston, Texas, United States
Progressive Clinical Research /ID# 238565
San Antonio, Texas, United States
Dermatology Specialists of Spokane /ID# 238809
Spokane, Washington, United States
West Virginia Research /ID# 238517
Morgantown, West Virginia, United States
Dr. Chih-ho Hong Medical Inc. /ID# 238864
Surrey, British Columbia, Canada
Wiseman Dermatology Research /ID# 238867
Winnipeg, Manitoba, Canada
SimcoDerm Medical and Surgical Dermatology Center /ID# 238861
Barrie, Ontario, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 238865
London, Ontario, Canada
Lynderm Research Inc. /ID# 243199
Markham, Ontario, Canada
K. Papp Clinical Research /ID# 239695
Waterloo, Ontario, Canada
Nagoya City University Hospital /ID# 239286
Nagoya, Aichi-ken, Japan
Takagi Dermatology Clinic /ID# 239274
Obihiro-shi, Hokkaido, Japan
JR Sapporo Hospital /ID# 239277
Sapporo, Hokkaido, Japan
Mie University Hospital /ID# 239275
Tsu, Mie-ken, Japan
Okayama University Hospital /ID# 239285
Okayama, Okayama-ken, Japan
Kansai Medical University Hospital /ID# 239278
Hirakata-shi, Osaka, Japan
Hamamatsu University Hospital /ID# 239346
Hamamatsu, Shizuoka, Japan
The Jikei University Hospital /ID# 239319
Minato-ku, Tokyo, Japan
NTT Medical Center Tokyo /ID# 239287
Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 239320
Shinjuku-ku, Tokyo, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M18-816
Identifier Type: -
Identifier Source: org_study_id