Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis

Phase 2/3 Completed 20 enrolled R-Pharm International, LLC Center of Pharmaceutical Analytics LLC · collab Data Management 365 · collab Unimed Laboratories · collab

RandomizedSequentialTriple-blindTreatment

Summary

The goal of this study was to evaluate the Efficacy and Safety of RPH-104 Treatment in patients in comparison to placebo with Idiopathic Recurrent Pericarditis

Timeline

Start: 2020-02-12
Primary completion: 2022-01-24
Completion: 2022-03-22

Outcome

Met primary endpoint

paper Recurrence of pericarditis occurred in 9 of 10 patients in the placebo group, and there were no recurrence events in goflikicept group within 24 weeks after randomization (P < 0.001). PMID 37380301 ↗

release “В ходе клинического исследования II/III фазы глофликицепта при терапии пациентов с идиопатическим рецидивирующим перикардитом удалось достичь всех заявленных конечных точек оценки эффективности.” r-pharm.com ↗

Publications

Myachikova VY, Maslyanskiy AL, Moiseeva OM, Vinogradova OV, Gleykina EV, Lavrovsky Y, Abbate A, Grishin SA, Egorova AN, Schedrova ML, Samsonov MY. Treatment of Idiopathic Recurrent Pericarditis With Goflikicept: Phase II/III Study Results. J Am Coll Cardiol. 2023 Jul 4;82(1):30-40. doi: 10.1016/j.jacc.2023.04.046.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Goflikicept	Monoclonal antibody	80 mg	Subcutaneous