Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.

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Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Jaktinib 100mg BID (twice daily)

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

Participants will receive 100 mg Jaktinib orally twice daily for 32 weeks

Interventions

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Jaktinib

Participants will receive 100 mg Jaktinib orally twice daily for 32 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The investigators concluded that the participants continued to benefit from treatment with Jaktinib.
* The participants have been fully informed and voluntarily signed informed consent.
* The participants completed the ZGJAK029 study for 16 weeks of treatment and visitation and had good compliance.
* The interval between the participants' first dose and the last dose of ZGJAK029 ≤ 4 weeks.

Exclusion Criteria

* There were any grade ≥3 adverse events within 4 weeks prior to enrollment and no return to grade 1 or normal.
* Within 4 weeks prior to enrollment, participants had the following infectious diseases: tuberculosis infection requiring treatment; HIV-positive, syphilis, HBV infection, HCV infection.
* The investigators considered participants unsuitable for this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No