NCT05044234

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Cedirogant	Capsule, Oral
DRUG	Placebo	Capsule, Oral

Timeline

• Start date: 2021-11-16
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2021-09-14
• Last updated: 2023-11-29
• Results posted: 2023-11-29

Locations

53 sites across 3 countries: United States, Canada, Japan

Regulatory

• FDA-regulated drug study