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Plaque PsoriasisPhase 2NCT06972888

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

A Phase 2 study testing AC-201 in people with Plaque Psoriasis, run by Accro Bioscience (Suzhou) Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
AC-201
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
145 participants
Where
1 siteChina
Study dates
23 Apr 2024to 28 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of China Medical University

    Shenyang

Other trials in China

About this study

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

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

Read the 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.

Being tested
AC-201, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC-201Drug

    AC-201 tablets will be administered orally

  • PlaceboDrug

    Matching placebo tablets will be administered orally.

Study groups in NCT06972888
Study groupRoleWhat they receive
Group 1: AC-201 Dose 1ExperimentalSubjects will receive AC-201 Dose 1 as tablets orally twice daily from Week 0 through W12
Receives: Drug: AC-201
Group 2: AC-201 Dose 2ExperimentalSubjects will receive AC-201 Dose 2 as tablets orally twice daily from Week 0 through W12
Receives: Drug: AC-201
Group 3: AC-201 Dose 3ExperimentalSubjects will receive AC-201 Dose 3 as tablets orally twice daily from Week 0 through W12
Receives: Drug: AC-201
Group 4: PlaceboExperimentalSubjects will receive matching placebo as tablets orally twice daily from Week 0 through W12
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (5)

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

    Change from baseline in PASI score 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.

    Measured: Baseline and Week 12

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

    Percentage of subjects achieved Psoriasis Area Severity Index (PASI) 90, (greater than or equal to 90% 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.

    Measured: Week 12

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

    Percentage of subjects achieved sPGA 0/1 at Week 12 will be reported. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 5 (0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling).

    Measured: Week 12

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

    Change from baseline in BSA at Week 12 will be reported. BSA is a commonly used measure of extent of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed.

    Measured: Baseline and Week 12

  5. Number of subjects with Adverse Events

    An Adverse Event (AE) is defined as any new untoward medical condition or worsening of a pre-existing medical condition following or during exposure to an investigation product, whether or not considered causally related to the product.

    Measured: Up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start23 Apr 2024
  3. Primary completion7 Mar 2025
  4. Study completion28 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06972888
Sponsor's protocol ID
AC201-003
Status last verified
May 2025
First submitted
7 May 2025
Last updated
22 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AC-201 in people with Plaque Psoriasis, run by Accro Bioscience (Suzhou) Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects achieved Psoriasis Area Severity Index (PASI) 75 at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06972888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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