A Study to Assess Adverse Events and Disease Activity with Cedirogant (ABBV-157) in Adult Participants with Moderate to Severe Psoriasis

JRCT ID: jRCT2061210069

Registered date:14/01/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Psoriasis
• Date of first enrollment: 01/04/2022
• Target sample size: 200
• Countries of recruitment: United States,Japan,Canada,Japan
• Study type: Interventional
• Intervention(s): The subject will receive cedirogant or placebo.

Outcome(s)

Primary Outcome

Percentage of participants achieving >=75% reduction from baseline in Psoriasis Area Severity Index
(PASI) score (PASI 75) at week16.

• Secondary Outcome: Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both
• Include criteria: Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.

Exclude criteria

- Primary non-responders to previous anti-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.

Related Information

• Primary Sponsor: Yamazaki Hayato
• Secondary ID(s): NCT05044234