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NOT YET RECRUITING
NCT07880886
PHASE3

Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever

Sponsor: R-Pharm

View on ClinicalTrials.gov

Summary

The primary objective is to evaluate the main pharmacokinetic (PK) parameters, efficacy, and safety of goflikicept (GFC) in children and adolescents with colchicine-resistant or colchicine-intolerant familial Mediterranean fever (FMF).

Official title: International, Multicenter, Open-label Clinical Study of Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Participants With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-12

Completion Date

2030-04

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

RPH-104

solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial.

Locations (3)

Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology

Moscow, Russia

State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department" (GBUZ "Morozovskaya DGBK DZM")

Moscow, Russia

LLC "Medical Technologies"

Saint Petersburg, Russia