Evaluating Jaktinib for treating active Ankylosing Spondylitis
An Open-Label, Multicenter, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
This study is testing if Jaktinib can help people with active ankylosing spondylitis feel better and manage their symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | Jaktinib |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05861128 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of Jaktinib in patients diagnosed with active ankylosing spondylitis. Participants who have previously completed a related study will receive Jaktinib treatment to determine its effectiveness in managing their condition. The study will monitor participants for any adverse effects and overall improvements in their symptoms. The goal is to provide further evidence on the benefits of Jaktinib for this patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals who have completed a prior study with Jaktinib and have active ankylosing spondylitis.
Not a fit: Patients with recent severe adverse events or certain infectious diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from active ankylosing spondylitis.
How similar studies have performed: Other studies evaluating similar treatments for ankylosing spondylitis have shown promising results, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- Renji Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Chunde Bao — RenJi Hospital
- Study coordinator: Bin Xie
- Email: xieb@zelgen.com
- Phone: +86-0512-57018310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.