A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.

Detailed Description
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This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.

Official Title
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A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: AK101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged ≥ 18 years. Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3. Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 6 months after the last study drug administration. Exclusion Criteria: Forms of psoriasis other than chronic plaque-type psoriasis. History or evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening. History of prohibited psoriasis treatments within 2/4 weeks before randomization. History of IL12/23 or IL-23 inhibitors therapy. Inadequate washout period of prior biological therapy. History of malignant tumour within 5 years before screening. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK101<br> | Drug: AK101<br>* Subjects will receive AK101 subcutaneous injection at week 0 and week 4, and will follow up to week 16.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subjects will receive placebo subcutaneous injection at week 0 and week 4, and will follow up to week 16.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline. |  | At week 16 | 
| Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1). |  | At week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who achieved at least 50% (PASI 50), 75% (PASI75, except week 16) and 90% (PASI 90) reduction in PASI score at each visit. |  | Baseline to week 16 | 
| Percentage of subjects who achieved sPGA 0/1 at each visit. |  | Baseline to week 16 | 
| Percentage change of PASI from baseline. |  | Baseline to week 16 | 
| PK: AK101 serum concentration at different time points after administration. |  | Baseline to week 16 | 
| Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA). |  | Baseline to week 16 | 
| Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE). |  | Baseline to week 16 |