Clinical trial NCT06972888: A Phase II Clinical Study of AC-201 Tablets in Subjects With Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Accro Bioscience (Suzhou) Limited
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

-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 Criteria:

* 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

Primary outcomes:
measure: Percentage of subjects achieved Psoriasis Area Severity Index (PASI) 75 at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change from baseline in Psoriasis Area Severity Index (PASI) score at Week12
timeFrame: Baseline and Week 12
measure: Percentage of subjects achieved Psoriasis Area Severity Index (PASI) 90 at Week 12
timeFrame: Week 12
measure: Percentage of subjects achieved static Physician Global Assessment (sPGA) of 0 or 1 (sPGA 0/1) at Week 12
timeFrame: Week 12
measure: Change from baseline in Body Surface Area (BSA) at Week 12
timeFrame: Baseline and Week 12
measure: Number of subjects with Adverse Events
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Hospital of China Medical University
Study officials:
References: