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NCT05861102
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)
Phase 3 trial testing Jaktinib in Ankylosing Spondylitis in 265 participants. Participants enrolled and being followed up; not accepting new ones.
1 May 2026
Quick facts
| Lead sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 265 |
| Start date | 20 July 2023 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 July 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Jaktinib — full drug profile →
- Placebo
Conditions studied
- Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd — full company profile →
Who can join
Adults 18 to 65, any sex, with Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 16
Time frame: Week 16
ASAS40 is defined as a \>= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.
Sponsor's own description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05861102
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Jaktinib
Trials testing the same drug.
- NCT06193148 — A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants · Phase 1 · completed
- NCT05255237 — Extension Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata · Phase 3 · completed
- NCT04866056 — Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF. · Phase 1, PHASE2 · terminated
- NCT05051761 — Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata · Phase 3 · completed
- NCT04612699 — A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis · Phase 2 · completed
Other recruiting trials for Ankylosing Spondylitis
Currently open trials in the same condition.
- NCT07510789 — Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis · recruiting
- NCT07261644 — A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS) · Phase 3 · recruiting
- NCT07390929 — Clinical Trial Study on the Improved New Method of Acupotomy for AS · NA · recruiting
- NCT06905288 — Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea. · recruiting
- NCT07166874 — The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis · NA · recruiting
Other Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials
Trials by the same sponsor.
- NCT05279001 — A Safety and Tolerability Study of Jaktinib · Phase 1 · unknown
- NCT06193148 — A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants · Phase 1 · completed
- NCT06132243 — Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions · Phase 1 · completed
- NCT05864573 — Study of ZGGS15 in Patients With Advanced Solid Tumors · Phase 1 · completed
- NCT05584800 — Study of ZGGS18 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05861102 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Last refreshed: 30 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05861102.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing