A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis

Study Overview
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Brief Summary
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This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Jaktinib in Patients With Moderate-to-Severe Plaque Psoriasis

Conditions
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Moderate-to-Severe Plaque Psoriasis

Intervention / Treatment
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* Drug: Jaktinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 65 years old (including lower limit), no gender limit； You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study； You must have active plaque psoriasis covering at least 10% body surface area； You must have Psoriasis Area and Severity Index (PASI) score of at least 12；You must have Static Physician's Global Assessment (sPGA) score of at least 3； The patient can communicate well with the investigator and follow the research and follow-up procedures； Understand and voluntarily sign the informed consent form. Exclusion Criteria: You must not have prior treatment with an oral Janus kinase (JAK) inhibitor； You must not have received a phototherapy within 4 weeks prior to entry into the study； You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)； You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib 50mg Bid<br>Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid | Drug: Jaktinib<br>* Administered orally<br>Drug: Placebo<br>* Administered orally<br>|
| Experimental: Jaktinib 75mg Bid<br>Jaktinib 75mg Bid+ Placebo 50mg*2 Bid | Drug: Jaktinib<br>* Administered orally<br>Drug: Placebo<br>* Administered orally<br>|
| Experimental: Jaktinib 100mg Bid<br>Jaktinib 50mg*2 Bid+ Placebo 75mg Bid | Drug: Jaktinib<br>* Administered orally<br>Drug: Placebo<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Placebo 50mg*2 Bid+ Placebo 75mg Bid | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) | The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear | Week 8、12、16、20、24 |