Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction
Summary
The goal of the study was to evaluate the effect of single administration of RPH-104 at 80 mg and 160 mg on parameters of systemic inflammation and outcomes of the disease in subjects with ST-segment elevation myocardial infarction (STEMI)
Timeline
- Start
- 2020-12-07
- Primary completion
- 2021-11-03
- Completion
- 2022-10-10
Outcome
Met primary endpoint
registry analysis (other test); RPH-104 80 mg vs Placebo; Least square means ratio 0.58 (95% CI 0.37 to 0.91) NCT04463251 ↗
registry analysis (other test); RPH-104 160 mg vs Placebo; Least square means ratio 0.58 (95% CI 0.37 to 0.91) NCT04463251 ↗
registry analysis (other test); RPH-104 80 mg vs Placebo; Least square means ratio 0.54 (95% CI 0.34 to 0.87) NCT04463251 ↗
registry analysis (other test); RPH-104 160 mg vs Placebo; Least square means ratio 0.60 (95% CI 0.37 to 0.95) NCT04463251 ↗
Publications
- Abbate A, Van Tassell B, Bogin V, Markley R, Pevzner DV, Cremer PC, Meray I, Privalov DV, Taylor A, Grishin SA, Egorova AN, Ponomar EG, Lavrovsky Y, Samsonov MY; RPH-104 STEMI Study Investigators. Results of International, Double-Blind, Randomized, Placebo-Controlled, Phase IIa Study of Interleukin-1 Blockade With RPH-104 (Goflikicept) in Patients With ST-Segment-Elevation Myocardial Infarction (STEMI). Circulation. 2024 Aug 13;150(7):580-582. doi: 10.1161/CIRCULATIONAHA.124.069396. Epub 2024 Aug 12. No abstract available.
- Samsonov M, Bogin V, Van Tassell BW, Abbate A. Interleukin-1 blockade with RPH-104 in patients with acute ST-elevation myocardial infarction: study design and rationale. J Transl Med. 2021 Apr 26;19(1):169. doi: 10.1186/s12967-021-02828-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Goflikicept | Monoclonal antibody | 80 mg | Subcutaneous |
| Subject | Goflikicept | Monoclonal antibody | 160 mg | Subcutaneous |