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

NCT06972888 | Completed Phase 2

• 1 other identifier: AC201-003
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects achieved Psoriasis Area Severity Index (PASI) 75 at Week 12

  Percentage of subjects achieved PASI 75 (greater than or equal to 75% improvement from baseline in PASI) at Week 12 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

  Week 12

Secondary Outcomes (5)

• Change from baseline in Psoriasis Area Severity Index (PASI) score at Week12

  Baseline and Week 12

• Percentage of subjects achieved Psoriasis Area Severity Index (PASI) 90 at Week 12

  Week 12

• Percentage of subjects achieved static Physician Global Assessment (sPGA) of 0 or 1 (sPGA 0/1) at Week 12

  Week 12

• Change from baseline in Body Surface Area (BSA) at Week 12

  Baseline and Week 12

• Number of subjects with Adverse Events

  Up to Week 16

Study Arms (4)

Group 1: AC-201 Dose 1

EXPERIMENTAL

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

Drug: AC-201

Group 2: AC-201 Dose 2

EXPERIMENTAL

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

Drug: AC-201

Group 3: AC-201 Dose 3

EXPERIMENTAL

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

Drug: AC-201

Group 4: Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

AC-201 DRUG

AC-201 tablets will be administered orally

Group 1: AC-201 Dose 1; Group 2: AC-201 Dose 2; Group 3: AC-201 Dose 3

Placebo DRUG

Matching placebo tablets will be administered orally.

Group 4: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accro Bioscience (Suzhou) Limited: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, China

Location

MeSH Terms

Interventions

diacerein

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: April 23, 2024
• Primary Completion: March 7, 2025
• Study Completion: April 28, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)