NCT05092776 - Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 29, 2021

Primary Completion Date

January 31, 2025

Study Completion Date

October 30, 2025

Conditions

Familial Mediterranean FeverFMF

Interventions

BIOLOGICAL

RPH-104

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

DRUG

Placebo

Normal Saline (0.9% Sodium Chloride solution for subcutaneous Injection), 2 mL in the 4 mL-glass vial. The placebo will contain no active pharmaceutical ingredients.

Trial Locations (14)

34093

Istanbul University Istanbul Faculty of Medicine, Istanbul

34098

Istanbul University Cerrahpasa Faculty of Medicine, Istanbul

119021

Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow

125284

Multidisciplinary Scientific and Clinical Center named after S.P. Botkin, Moscow

191025

Medical Technologies Ltd, Saint Petersburg

197101

Saint-Petersburg Pasteur Institute, Saint Petersburg

355000

Terafarm, Llc, Stavropol

0001

Center of Medical Genetics and Primary Health Care, Yerevan

0052

Mikaelyan Institute Of Surgery CJSC, Yerevan

0179

Inova LLC, Tbilisi

0180

The First Medical Center Ltd., Tbilisi

06230

Hacettepe University Faculty of Medicine, Ankara

06560

Gazi University Faculty of Medicine, Ankara

07070

Akdeniz University Faculty of Medicine, Antalya