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RPH-104 for Recurrent Pericarditis

Phase 2 & 3
Waitlist Available
Research Sponsored by R-Pharm Overseas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presents with at least the third episode of pericarditis during screening and within ≤ 7 days prior to and including RI baseline
Recurrent pericarditis diagnosis
Must not have
Uncontrolled diabetes mellitus
Currently receiving CS at a dose of > 60 mg/day prednisone (or equivalent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 24 (of the rw period)
Awards & highlights

Summary

This trial tests RPH-104, an injectable medication, in patients with recurrent pericarditis. It aims to reduce inflammation by calming the immune response. The study will evaluate its effectiveness and safety over a period of time.

Who is the study for?
This trial is for individuals with recurrent pericarditis, who've had at least one flare-up meeting specific criteria and are currently experiencing or have recently experienced another episode. Participants must be willing to stop taking certain anti-inflammatory drugs by Week 12 and follow contraceptive guidelines if applicable. People with severe allergies to RPH-104, certain health conditions, uncontrolled diabetes, organ transplants, recent malignancies, mental disorders affecting study compliance, substance abuse issues, severe kidney problems or those on other clinical trials are excluded.
What is being tested?
The trial tests the effectiveness and safety of a medication called RPH-104 in patients with recurrent pericarditis compared to a placebo. It also looks into how the body processes multiple doses of RPH-104. Patients will be randomly assigned to receive either RPH-104 or a placebo while their response to treatment is monitored.
What are the potential side effects?
While not specified here, potential side effects may include reactions related to hypersensitivity such as rash or itching (since people with known hypersensitivity are excluded), as well as any common drug-related adverse events like nausea, headache or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least three episodes of pericarditis recently.
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I have been diagnosed with recurrent pericarditis.
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I agree to use effective birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My diabetes is not well-controlled.
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I am currently taking more than 60 mg/day of prednisone or its equivalent.
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My heart inflammation is due to a specific condition.
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I have severe kidney problems.
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I have not had any other cancers in the last 5 years.
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I have had an organ transplant or might need one soon.
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I have never had active tuberculosis or been at risk for it.
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My immune system is not working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 24 (of the rw period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 (of the rw period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time (days) to the pericarditis recurrence within 24 weeks after randomization in patients with recurrent pericarditis treated with RPH-104 compared to placebo.
Secondary study objectives
Percentage of days with no or minimal pain in the first 16 weeks of the RW period in RPH-104 group compared to placebo.
Proportion of subjects who maintained Clinical Response at Week 16 of the RW period in RPH-104 group compared to placebo.

Side effects data

From 2017 Phase 1 trial • 35 Patients • NCT02667639
52%
Nervous system disorders
32%
Gastrointestinal disorders
24%
Infections and infestations
12%
General disorders and administration site conditions
8%
Musculoskeletal and connective tissue disorders
8%
Pollakiuria
8%
Skin and subcutaneous tissue disorders
8%
Investigations
4%
Respiratory, thoracic and mediastinal disorders
4%
Psychiatric disorders
4%
Ear and labyrinth disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RPH-104 80 mgExperimental Treatment1 Intervention
Patients will receive RPH-104 dose 160 mg subcutaneously on Day 0, and 80 mg on Day 7, Day 14 and thereafter once in two weeks.
Group II: PlaceboPlacebo Group1 Intervention
Patients (who achieved clinical response defined above by the randomized withdrawal baseline) will receive placebo subcutaneously once every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RPH-104
2016
Completed Phase 3
~60

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for pericarditis include nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, corticosteroids, and interleukin-1 (IL-1) inhibitors like RPH-104. NSAIDs reduce inflammation and pain by inhibiting cyclooxygenase enzymes, which are involved in the inflammatory process. Colchicine works by disrupting microtubule formation, thereby reducing leukocyte activity and inflammation. Corticosteroids suppress the immune response and inflammation by inhibiting multiple inflammatory pathways. IL-1 inhibitors, such as RPH-104, specifically block the activity of interleukin-1, a key cytokine in the inflammatory response, thereby reducing inflammation and preventing recurrent pericarditis episodes. These treatments are crucial for pericarditis patients as they help manage pain, reduce inflammation, and prevent complications and recurrences.

Find a Location

Who is running the clinical trial?

Data Management 365Industry Sponsor
11 Previous Clinical Trials
4,190 Total Patients Enrolled
2 Trials studying Pericarditis
37 Patients Enrolled for Pericarditis
Keystat, LLCUNKNOWN
2 Previous Clinical Trials
218 Total Patients Enrolled
R-Pharm Overseas, Inc.Lead Sponsor
2 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05107934 — Phase 2 & 3
Pericarditis Research Study Groups: Placebo, RPH-104 80 mg
Pericarditis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05107934 — Phase 2 & 3
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05107934 — Phase 2 & 3
~33 spots leftby May 2025
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