Status:
COMPLETED
A Phase II Clinical Study of AC-201 Tablets in Subjects With Plaque Psoriasis
Lead Sponsor:
Accro Bioscience (Suzhou) Limited
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of AC-201 tablets compared with placebo in subjects with moderate-to-severe plaque psoriasis
Detailed Description
AC-201 is a highly selective dual inhibitor of TYK2 and JAK1, which are targeting the signal transduction of a variety of cytokines in psoriasis. This study is to evaluate the efficacy and safety of A...
Eligibility Criteria
Inclusion
- Stable plaque psoriasis (defined as no morphological or severity changes for ≥ 6 month) and meet the following disease severity at screening and baseline: Total PASI score ≥ 12, and Total sPGA ≥ 3, and Total BSA ≥ 10%
- Candidate for phototherapy or systemic treatment for plaque psoriasis
Exclusion
- Other form of psoriasis (e.g., erythrodermic, pustular or guttate)
- Current or history for drug-induced psoriasis (e.g., psoriasis induced by beta blockers, calcium channel blockers, antimalarial drugs, or lithium)
- History or risk of tuberculosis (TB)
- Have received TYK2 inhibitor and lack of efficacy deemed by investigator
- Topical medications/treatments for psoriasis within 2 weeks prior to administration of any study medication
- Systemic medications/treatments for psoriasis within 4 weeks prior to administration of any study medication
- Has received biological treatment (e.g., anti-TNFα, anti-IL12/23, anti-IL17) for psoriasis less than 5 half-lives of treatment prior to administration of any study medication
Key Trial Info
Start Date :
April 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT06972888
Start Date
April 23 2024
End Date
April 28 2025
Last Update
May 22 2025
Active Locations (1)
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1
The First Hospital of China Medical University
Shenyang, China