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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Drug: Jaktinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05861128

ZGJAK030

Details and patient eligibility

About

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

Enrollment: 258 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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258 participants in 1 patient group

Jaktinib 100mg BID (twice daily)

Experimental group

Treatment:

Drug: Jaktinib