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NCT07145229
A Randomized, Double-blind, Multicenter, Colchicine and Placebo-controlled Study to Evaluate the Efficacy and Safety of ABP-745 in Subjects With an Acute Gout Flare
Phase 2 trial testing ABP-745 Dose A in Acute Gouty Arthritis in 380 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | Atom Therapeutics Co., Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 380 |
| Start date | 26 August 2025 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 June 2026 |
| Sites | 38 locations across United States, Australia, China |
Drugs / interventions tested
- ABP-745 Dose A — full drug profile →
- ABP-745 Dose B — full drug profile →
- Colchicine (COLCHICINE) — full drug profile →
- Placebo
Conditions studied
- Acute Gouty Arthritis — all drugs for Acute Gouty Arthritis →
- Gout Flare — all drugs for Gout Flare →
- Gout Flares — all drugs for Gout Flares →
- Acute Gout Flare — all drugs for Acute Gout Flare →
Sponsor
Atom Therapeutics Co., Ltd — full company profile →
Who can join
Adults 18 to 70, any sex, with Acute Gouty Arthritis or Gout Flare. 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.
-
Change in Visual Analog Scale (VAS) pain score of the target joint
Time frame: 24 hours post the first dose of study drug
Change from baseline in 0-100 mm VAS pain score of the target joint
Sponsor's own description
A randomized, double-blind, international multicenter, colchicine and placebo-controlled study to evaluate the efficacy and safety of ABP-745 in subjects with acute gout. Efficacy of ABP-745 in reducing pain and swelling compared with standard colchicine treatment and placebo will be evaluated in participants with acute gout. The primary efficacy measurement will be pain score after treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07145229
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Gouty Arthritis
Currently open trials in the same condition.
- NCT07453004 — A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With · Phase 2 · recruiting
Other Atom Therapeutics Co., Ltd trials
Trials by the same sponsor.
- NCT07323095 — Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia · Phase 2 · not yet recruiting
- NCT07367971 — Drug-Drug Interaction Study of ABP-671 in Gout Patients · Phase 1 · recruiting
- NCT06276556 — Extension Study of ABP-671 in Participants With Gout · Phase 2, PHASE3 · terminated
- NCT06258213 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers · Phase 1 · completed
- NCT05818085 — Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout · Phase 2, PHASE3 · completed
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 NCT07145229 (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 Atom Therapeutics Co., Ltd
- Last refreshed: 4 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/NCT07145229.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing