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Study of the Safety and Efficacy of RPH-104 in Preventing Recurrences in Patients With Idiopathic Recurrent Pericarditis

NCT05673902 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-11-15

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of RPH-104 for long-term use in a population of patients with idiopathic recurrent pericarditis who completed the main study CL04018068.

The primary objective of the study is to evaluate the safety of RPH-104 80 mg once every 2 weeks in patients with idiopathic recurrent pericarditis who completed the main study.

Conditions

  • Idiopathic Recurrent Pericarditis

Interventions

BIOLOGICAL

RPH-104

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

Sponsors & Collaborators

  • R-Pharm

    collaborator INDUSTRY

  • Unimed Laboratories

    collaborator INDUSTRY

  • Data Management 365

    collaborator INDUSTRY

  • Exacte Labs LLC

    collaborator INDUSTRY

  • 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Russia

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 NCT05673902 on ClinicalTrials.gov