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Efficacy and Safety of RPH-104 Treatment in Patients With Recurrent Pericarditis

NCT05107934 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-15

No results posted yet for this study

Summary

The primary purpose of this study is the evaluation of the efficacy and safety of RPH-104 treatment in patients with recurrent pericarditis.

Pharmacokinetic and pharmacodynamic parameters of RPH-104 multiple doses in this patient population will be assessed as well.

Conditions

  • Recurrent Pericarditis

Interventions

BIOLOGICAL

RPH-104

solution for subcutaneous injection, 40 mg/mL

DRUG

Placebo

0.9% Sodium Chloride solution for Injection

Sponsors & Collaborators

  • Data Management 365

    collaborator INDUSTRY

  • Keystat, LLC

    collaborator INDUSTRY

  • R-Pharm Overseas, Inc.

    lead INDUSTRY

Principal Investigators

  • Yan Lavrovsky · R-Pharm Overseas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-05-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

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 NCT05107934 on ClinicalTrials.gov