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NCT06298071
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
Phase 1 trial testing SIBP-R002 in Gout in 36 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | Shanghai Institute Of Biological Products |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 3 March 2023 |
| Primary completion | 30 December 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- SIBP-R002 — full drug profile →
- SIBP-R002 — full drug profile →
- SIBP-R002 — full drug profile →
- Methotrexate — full drug profile →
Conditions studied
- Gout — all drugs for Gout →
Sponsor
Shanghai Institute Of Biological Products
Who can join
Adults 18 to 70, any sex, with Gout. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06298071
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of SIBP-R002
Trials testing the same drug.
- NCT05302388 — A Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia · Phase 1 · completed
Other recruiting trials for Gout
Currently open trials in the same condition.
- NCT07414394 — Tigulixostat (IBI128) vs Febuxostat in Gout · Phase 3 · recruiting
- NCT07367971 — Drug-Drug Interaction Study of ABP-671 in Gout Patients · Phase 1 · recruiting
- NCT07346079 — Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares · Phase 4 · recruiting
- NCT07089875 — A Study of Dotinurad Versus Allopurinol in Participants With Gout · Phase 3 · recruiting
- NCT05507723 — Tight Control of Gouty Arthritis Compared to Usual Care · NA · recruiting
Other Shanghai Institute Of Biological Products trials
Trials by the same sponsor.
- NCT07363837 — Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants · Phase 1, PHASE2 · not yet recruiting
- NCT07327398 — Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 2 · not yet recruiting
- NCT07253675 — Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo · Phase 2 · not yet recruiting
- NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
- NCT07205198 — A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects. · Phase 1 · 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 NCT06298071 (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 Shanghai Institute Of Biological Products
- Last refreshed: 8 January 2026
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/NCT06298071.
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