NCT06972888

A Phase II Clinical Study of AC-201 Tablets in Subjects With Plaque Psoriasis

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of AC-201 Tablets in Subjects With Moderate-to-severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Accro Bioscience (Suzhou) Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 AC-201 tablets in subjects with moderate-to-severe plaque psoriasis. The efficacy will be determined by the superior percentage of subjects achieved Psoriasis Area and Severity Index (PASI) 75 (greater than or equal to 75% improvement in PASI) compared with placebo. The treatment of AC-201 will be up to 12 weeks and followed by a 4-week safety follow-up, and total duration will be up to 16 weeks. Adverse Events, clinical laboratory assessments, electrocardiograms (ECGs), vital signs, physical examinations, concomitant medications will be monitored throughout the study. Meanwhile, pharmacokinetics and pharmacodynamics will be analyzed.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	AC-201	AC-201 tablets will be administered orally
DRUG	Placebo	Matching placebo tablets will be administered orally.

Timeline

• Start date: 2024-04-23
• Primary completion: 2025-03-07
• Completion: 2025-04-28
• First posted: 2025-05-15
• Last updated: 2025-05-22

Locations

1 site across 1 country: China