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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Jaktinib; Drug: placebo

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jaktinib 50mg BID; Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks.	Drug: Jaktinib; Administered orally.
Experimental: Jaktinib 75mg BID; Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks.	Drug: Jaktinib; Administered orally.
Placebo Comparator: placebo; Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.	Drug: placebo; Administered orally.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: ZGJAK018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No