Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata

Study Overview
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Brief Summary
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This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called Jaktinib) in adults (≥18 years and <65 years) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Official Title
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A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Jaktinib in Adult Patients With Severe Alopecia Areata

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Jaktinib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants voluntarily sign the informed consent form (ICF); Age ≥ 18 years and <65 years, either male or female; Clinical presentation compatible with alopecia areata with a current episode lasting not exceeding ≤8 years. At least 50% scalp hair loss. Willing to comply with the study visits and requirements of the study protocol. Exclusion Criteria: participants has taken a JAK inhibitor prior to randomization; participants who are unsuitable to the trial, as identified by the investigator.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib 50mg BID<br>Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks. | Drug: Jaktinib<br>* Administered orally.<br>|
| Experimental: Jaktinib 75mg BID<br>Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks. | Drug: Jaktinib<br>* Administered orally.<br>|
| Placebo Comparator: placebo<br>Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks. | 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 Severity of Alopecia Tool (SALT) ≤ 20 at Week 24 | SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving 50% Improvement of SALT (SALT50) | Percentage of participants achieving SALT50 | Week 24 |