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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2025-04-28

Brief Summary

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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

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Detailed Description

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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

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1: AC-201 Dose 1

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

Group Type EXPERIMENTAL

AC-201

Intervention Type DRUG

AC-201 tablets will be administered orally

Group 2: AC-201 Dose 2

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

Group Type EXPERIMENTAL

AC-201

Intervention Type DRUG

AC-201 tablets will be administered orally

Group 3: AC-201 Dose 3

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

Group Type EXPERIMENTAL

AC-201

Intervention Type DRUG

AC-201 tablets will be administered orally

Group 4: Placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo tablets will be administered orally.

Interventions

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AC-201

AC-201 tablets will be administered orally

Intervention Type DRUG

Placebo

Matching placebo tablets will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No