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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: AC-201 Dose 1 | Experimental | Subjects will receive AC-201 Dose 1 as tablets orally twice daily from Week 0 through W12 |
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| Group 2: AC-201 Dose 2 | Experimental | Subjects will receive AC-201 Dose 2 as tablets orally twice daily from Week 0 through W12 |
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| Group 3: AC-201 Dose 3 | Experimental | Subjects will receive AC-201 Dose 3 as tablets orally twice daily from Week 0 through W12 |
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| Group 4: Placebo | Experimental | Subjects will receive matching placebo as tablets orally twice daily from Week 0 through W12 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-201 | Drug | AC-201 tablets will be administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Shenyang | China |
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| ID | Term |
|---|---|
| C025292 | diacerein |
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| Placebo | Drug | Matching placebo tablets will be administered orally. |
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| Baseline and Week 12 |
| 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. | Week 12 |
| 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). | Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Up to Week 16 |