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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05051761

Acronym

Enrollment

425

Registered

2021-09-21

Start date

2021-09-04

Completion date

2023-12-27

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Brief summary

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.

Interventions

DRUGJaktinib

Administered orally.

DRUGplacebo

Administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24	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).

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving 50% Improvement of SALT (SALT50)	Week 24	Percentage of participants achieving SALT50

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026