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NCT Number: NCT05051761

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

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.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jaktinib

Drug

Administered orally.

Placebo

Drug

Administered orally.

Primary outcomes

  1. Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24

    Time frame: 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 outcomes

  1. Percentage of Participants Achieving 50% Improvement of SALT (SALT50)

    Time frame: Week 24

    Percentage of participants achieving SALT50

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Acronym: AA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2021
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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