Psoriasis Clinical Trial
A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
Summary
Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study will assess how safe and effective cedirogant (ABBV-157) is compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements are assessing disease activity in participants with plaque psoriasis.
Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants will be put into 1 of 4 groups, called treatment arms and each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 200 adult participants with moderate to severe plaque psoriasis will be enrolled at approximately 45 sites.
Participants will receive oral daily doses of cedirogant or placebo capsules for 16 weeks.
There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be 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.
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There are 52 Locations for this study
Birmingham Alabama, 35233, United States
Phoenix Arizona, 85006, United States
North Little Rock Arkansas, 72117, United States
Encino California, 91436, United States
North Hollywood California, 91606, United States
San Diego California, 92103, United States
Miami Florida, 33014, United States
Miami Florida, 33173, United States
Sweetwater Florida, 33172, United States
Tampa Florida, 33607, United States
Tampa Florida, 33607, United States
Tampa Florida, 33613, United States
Dawsonville Georgia, 30534, United States
Marietta Georgia, 30060, United States
Rolling Meadows Illinois, 60008, United States
Indianapolis Indiana, 46256, United States
Edina Minnesota, 55424, United States
Omaha Nebraska, 68144, United States
Kew Gardens New York, 11415, United States
Williamsville New York, 14221, United States
Charlotte North Carolina, 28277, United States
Wilmington North Carolina, 28403, United States
Cleveland Ohio, 44106, United States
Mason Ohio, 45040, United States
Portland Oregon, 97210, United States
Pittsburgh Pennsylvania, 15260, United States
Johnston Rhode Island, 02919, United States
Charleston South Carolina, 29407, United States
Rapid City South Dakota, 57702, United States
Nashville Tennessee, 37215, United States
Arlington Texas, 76011, United States
Austin Texas, 78759, United States
Bellaire Texas, 77401, United States
Houston Texas, 77004, United States
San Antonio Texas, 78229, United States
Spokane Washington, 99202, United States
Morgantown West Virginia, 26505, United States
Surrey British Columbia, V3R 6, Canada
Winnipeg Manitoba, R3M 3, Canada
Barrie Ontario, L4M 7, Canada
London Ontario, N6H 5, Canada
Markham Ontario, L3P 1, Canada
Waterloo Ontario, N2J 1, Canada
Nagoya shi Aichi, 467-8, Japan
Obihiro-shi Hokkaido, 080-0, Japan
Sapporo-shi Hokkaido, 060-0, Japan
Tsu-shi Mie, 514-8, Japan
Okayama-shi Okayama, 700-8, Japan
Hirakata-shi Osaka, 573-1, Japan
Hamamatsu-shi Shizuoka, 431-3, Japan
Minato-ku Tokyo, 105-8, Japan
Shinagawa-ku Tokyo, 141-8, Japan
Shinjuku-ku Tokyo, 160-0, Japan
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