NCT05255237

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

March 25, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

February 11, 2022

Last Update Submit

March 13, 2025

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

  • Number of subjects reporting treatment-emergent adverse events

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

    Baseline through week 24

Study Arms (1)

Jaktinib

EXPERIMENTAL

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

Drug: Jaktinib

Interventions

JaktinibDRUG

75mg BID

Jaktinib

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects voluntarily sign the informed consent form.
  • Patients who participated in ZGJAK018.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

11 Xizhimen South Street

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jianzhong Zhang, PhD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

  • Qianjin Lu, PhD

    Hospital for skin diseases, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2022

First Posted

February 24, 2022

Study Start

March 25, 2022

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations

CN(1)