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

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Alopecia Areata

Treatments: Drug: placebo; Drug: Jaktinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05051761

ZGJAK018

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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425 participants in 3 patient groups, including a placebo group

Jaktinib 50mg BID

Experimental group

Description:

Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks.

Treatment:

Drug: Jaktinib

Jaktinib 75mg BID

Experimental group

Description:

Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks.

Treatment:

Drug: Jaktinib

placebo

Placebo Comparator group

Description:

Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.

Treatment:

Drug: placebo