drugset
drugset / Trial / NCT04067492

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack

NCT04067492 ↗

Phase 2 Terminated 47 enrolled R-Pharm Center of Pharmaceutical Analytics LLC · collabCovance · collabData Matrix Solutions · collabOCT LLC · collabUnimed Laboratories · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary goal of the study was to evaluate the parameters of efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of RPH-104 in adult patients with acute gout attack.

Timeline

Start
2018-03-26
Primary completion
2020-03-16
Completion
2020-05-12

Outcome

Missed primary endpoint

Stopped (Enrollment): “In view of the continuing insufficient patient recruitment in the study due to the difficult epidemiological situation and the need for rational allocation of company resources, as well as based on the results of the interim analysis.”

registry RPH - 20 mg vs Voltaren® (Diclofenac); p = 0.1331; Mean Difference (Final Values) -2.05 NCT04067492 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diclofenac Other / unclassified 25 mg Oral
Subject Goflikicept Monoclonal antibody 4 mg Subcutaneous
Subject Goflikicept Monoclonal antibody 20 mg Subcutaneous
Subject Goflikicept Monoclonal antibody 40 mg Subcutaneous
Subject Goflikicept Monoclonal antibody 80 mg Subcutaneous
Subject Goflikicept Monoclonal antibody 160 mg Subcutaneous

Indications

gout