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

Primary Purpose

Alopecia Areata

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Jaktinib

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.
Patients who participated in ZGJAK018.

Exclusion Criteria:

Subjects who are unsuitable to the trial, as identified by the investigator.

Sites / Locations

11 Xizhimen South StreetRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Jaktinib

Arm Description

Patients will administer the study product twice per day for 24 weeks, for the safty assessment.

Outcomes

Primary Outcome Measures

Number of subjects reporting treatment-emergent adverse events

Patients with treatment-emergent adverse events/all patients *100%

Secondary Outcome Measures

Full Information

NCT ID

NCT05255237

First Posted

February 11, 2022

Last Updated

October 20, 2023

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05255237

Brief Title

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

Acronym

Official Title

A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Adult Patients With Moderate to Severe Alopecia Areata

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 25, 2022 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study (Unique Protocol ID: ZGJAK020) as an extension of the ongoing "Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (Unique Protocol ID:ZGJAK020)" study. After completion of ZGJAK018 study, the study will be directly extend with an "open-label design".

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Jaktinib

Arm Type

Experimental

Arm Description

Patients will administer the study product twice per day for 24 weeks, for the safty assessment.

Intervention Type

Drug

Intervention Name(s)

Jaktinib

Intervention Description

75mg BID

Primary Outcome Measure Information:

Title

Number of subjects reporting treatment-emergent adverse events

Description

Patients with treatment-emergent adverse events/all patients *100%

Time Frame

Baseline through week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects voluntarily sign the informed consent form. Patients who participated in ZGJAK018. Exclusion Criteria: Subjects who are unsuitable to the trial, as identified by the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaojun Wu

Phone

+86-0512-57018308

wuxj@zelgen.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianzhong Zhang, PhD

Organizational Affiliation

Peking University People's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qianjin Lu, PhD

Organizational Affiliation

Hospital for skin diseases, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

11 Xizhimen South Street

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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