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

NCT05051761 | Completed Phase 3

• 1 other identifier: ZGJAK018
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 2

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants Achieving 50% Improvement of SALT (SALT50)

  Week 24

Study Arms (3)

Jaktinib 50mg BID

EXPERIMENTAL

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

Drug: Jaktinib

Jaktinib 75mg BID

EXPERIMENTAL

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

Drug: Jaktinib

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Jaktinib DRUG

Administered orally.

Jaktinib 50mg BID; Jaktinib 75mg BID

placebo DRUG

Administered orally.

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• participants has taken a JAK inhibitor prior to randomization;
• participants who are unsuitable to the trial, as identified by the investigator.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Hospital for Skin Diseases, Chinese Academy of medical Sciences

Nanjing, Jiangsu, 210042, China

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

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

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: September 21, 2021
• Study Start: September 4, 2021
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CN (2)