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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

NCT05092776 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-12-06

No results posted yet for this study

Summary

Study purpose is an evaluation of efficacy and safety of RPH-104 in the population of subjects with Familial Mediterranean Fever (FMF) with colchicine resistance or intolerance(i.e. colchicine resistant (crFMF).. Primary objective is to determine proportion of subjects with complete response to treatment with RPH-104 compared to placebo among FMF subjects with colchicine resistance or intolerance.

Conditions

  • Familial Mediterranean Fever
  • FMF

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.

Sponsors & Collaborators

  • Data Management 365

    collaborator INDUSTRY

  • Atlant Clinical LLC

    collaborator UNKNOWN

  • R-Pharm JSC

    collaborator UNKNOWN

  • Unimed Laboratories

    collaborator INDUSTRY

  • Exacte Labs LLC

    collaborator INDUSTRY

  • Key Stat LLC

    collaborator UNKNOWN

  • TRPharm İlaç Sanayi Ticaret Anonim Şirketi and ASCOT SCIENCE Education and Consulting Ltd.

    collaborator UNKNOWN

  • Ascot Eğitim ve Danışmanlık LTD. ŞTİ.

    collaborator UNKNOWN

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2025-01-31
Completion
2025-10-30

Countries

  • Armenia
  • Georgia
  • Russia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092776 on ClinicalTrials.gov