Extension Study to Evaluate Safety and Efficacy of Jaktin... | NCT05255237

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

NCT05255237

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Status

Completed

Last Update Posted

Mar 18, 2025Actual

Enrollment

315Actual

Phase

Phase 3

Conditions

Alopecia Areata

Interventions

Jaktinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2022Actual

Primary Completion Date

Jun 28, 2024Actual

Completion Date

Jun 28, 2024Actual

First Submitted Date

Feb 11, 2022

First Submission Date that Met QC Criteria

Feb 22, 2022

First Posted Date

Feb 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2025

Last Update Posted Date

Mar 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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".

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

315Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Jaktinib	Experimental	Patients will administer the study product twice per day for 24 weeks, for the safety assessment.	Drug: Jaktinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Jaktinib	Drug	75mg BID	Jaktinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects reporting treatment-emergent adverse events	Patients with treatment-emergent adverse events/all patients *100%	Baseline through week 24

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jianzhong Zhang, PhD	Peking University People's Hospital	Principal Investigator
Qianjin Lu, PhD	Hospital for skin diseases, Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
11 Xizhimen South Street		Beijing	Beijing Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D000506	Alopecia Areata

Ancestor Terms

ID	Term
D000505	Alopecia
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided