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

Primary Purpose

Alopecia Areata

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jaktinib
placebo
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects 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:

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

Sites / Locations

  • Peking University People's Hospital
  • Hospital for Skin Diseases, Chinese Academy of medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Jaktinib 50mg BID

Jaktinib 75mg BID

placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Percentage of Participants Achieving 50% Improvement of SALT (SALT50)
Percentage of participants achieving SALT50

Full Information

First Posted
September 11, 2021
Last Updated
July 28, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05051761
Brief Title
Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata
Acronym
AA
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 4, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jaktinib 50mg BID
Arm Type
Experimental
Arm Description
Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks.
Arm Title
Jaktinib 75mg BID
Arm Type
Experimental
Arm Description
Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24
Description
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).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving 50% Improvement of SALT (SALT50)
Description
Percentage of participants achieving SALT50
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Wu
Organizational Affiliation
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Hospital for Skin Diseases, Chinese Academy of medical Sciences
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China

12. IPD Sharing Statement

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

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