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

Accro Bioscience (Suzhou) Limited

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: AC-201

Study type: Interventional

Funder types: Industry

Identifiers

NCT06972888

AC201-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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145 participants in 4 patient groups

Group 1: AC-201 Dose 1

Experimental group

Description:

Subjects will receive AC-201 Dose 1 as tablets orally twice daily from Week 0 through W12

Treatment:

Drug: AC-201

Group 2: AC-201 Dose 2

Experimental group

Description:

Subjects will receive AC-201 Dose 2 as tablets orally twice daily from Week 0 through W12

Treatment:

Drug: AC-201

Group 3: AC-201 Dose 3

Experimental group

Description:

Subjects will receive AC-201 Dose 3 as tablets orally twice daily from Week 0 through W12

Treatment:

Drug: AC-201

Group 4: Placebo

Experimental group

Description:

Subjects will receive matching placebo as tablets orally twice daily from Week 0 through W12

Treatment:

Drug: Placebo