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Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever

NCT05190991 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-16

No results posted yet for this study

Summary

The purpose of this study is to assess safety and efficacy of the long-term treatment with RPH-104 at doses of 80 or 160 mg once every 2 weeks (q2w) in patients with familial Mediterranean fever (FMF) with colchicine resistance or intolerance (i.e. colchicine resistant, crFMF), who completed the core study, during which they received at least one dose of RPH-104 (i.e. study patient population).

Conditions

  • Familial Mediterranean Fever
  • FMF

Interventions

BIOLOGICAL

RPH-104

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

Sponsors & Collaborators

  • Atlant Clinical LLC

    collaborator UNKNOWN

  • Unimed Laboratories

    collaborator INDUSTRY

  • Data Management 365

    collaborator INDUSTRY

  • R-Pharm JSC

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Exacte Labs LLC

    collaborator INDUSTRY

  • Key Stat LLC

    collaborator UNKNOWN

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • Armenia
  • Russia
  • Turkey (Türkiye)

Study Locations

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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 NCT05190991 on ClinicalTrials.gov