RPH-104 for Recurrent Pericarditis

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: R-Pharm Overseas, Inc.

Must be taking: NSAIDs, Colchicine, Corticosteroids

Must not be taking: TNF inhibitors, IL-6 inhibitors

Disqualifiers: Severe allergies, Tuberculosis, Uncontrolled diabetes, Malignancies, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RPH-104 to determine its effectiveness for recurrent pericarditis, a condition causing painful inflammation of the heart's lining. The study will assess whether RPH-104 can reduce symptoms and ensure its safety. Participants will receive either the new treatment or a placebo (a harmless pill with no active ingredients) for comparison. Individuals who have experienced at least two painful episodes of pericarditis and are currently undergoing another episode may qualify for this trial. As a Phase 2, Phase 3 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

If you are taking NSAIDs, colchicine, or corticosteroids, you can continue them at stable doses for at least 3 days before starting the trial. However, you should be willing to taper and stop these medications by Week 12 of the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RPH-104 has been tested for safety in people with recurring pericarditis, a condition where the lining around the heart becomes inflamed. In one study, none of the patients taking RPH-104 experienced a return of symptoms, unlike those who took a placebo (a harmless pill with no active medicine). This suggests that RPH-104 is well-tolerated. Another study examined the safety of RPH-104, administering 80 mg doses every two weeks. These studies provide evidence that RPH-104 is generally safe for people with this condition. While side effects can occur, current data indicate that most patients tolerate the treatment well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pericarditis?

Most treatments for recurrent pericarditis focus on managing inflammation with medications like colchicine, NSAIDs, or corticosteroids. But RPH-104 works differently, targeting a specific protein involved in inflammation called interleukin-1 (IL-1). This treatment is unique because it uses an injectable biologic approach, potentially offering a more targeted and effective way to reduce inflammation. Researchers are excited about RPH-104 because it may provide faster and more sustained relief from symptoms compared to existing therapies, improving patients' quality of life significantly.

What evidence suggests that RPH-104 might be an effective treatment for recurrent pericarditis?

In this trial, participants will receive either RPH-104, also known as goflikicept, or a placebo. Research has shown that RPH-104 may help treat recurrent pericarditis, a condition where the lining around the heart repeatedly becomes inflamed. Studies have found that this treatment lowers the chance of pericarditis returning compared to a placebo. It helps control the condition, reducing or eliminating symptoms, while maintaining a good balance of benefits and risks. Evidence suggests that RPH-104 can effectively prevent the condition from recurring and keep it in remission. ^{1 2 3 5 6}

Who Is on the Research Team?

Yan Lavrovsky

Principal Investigator

R-Pharm Overseas, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Voluntarily signed and dated Informed Consent Form for participation in the study

I have had at least three episodes of pericarditis recently.

I am willing to stop taking NSAIDs, colchicine, or corticosteroids by Week 12.

Exclusion Criteria

Pregnancy or breast-feeding

My diabetes is not well-controlled.

I am currently taking more than 60 mg/day of prednisone or its equivalent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Run-in single-blind treatment

Single-blind treatment with RPH-104, including stabilization, weaning, and monotherapy periods

16 weeks

Regular visits for treatment and monitoring

Randomized withdrawal

Double-blind treatment with RPH-104 or placebo

24 weeks

Bi-weekly visits for treatment and monitoring

Open-label treatment

Open-label treatment with RPH-104 for all subjects who did not discontinue

12 weeks

Bi-weekly visits for treatment

Safety follow-up

Monitoring of safety for patients who did not participate in the open-label extension

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• RPH-104

Trial Overview 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.

How Is the Trial Designed?

Group I: RPH-104 80 mg Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Patients (who achieved clinical response defined above by the randomized withdrawal baseline) will receive placebo subcutaneously once every 2 weeks.

Who Is Running the Clinical Trial?

R-Pharm Overseas, Inc.

Lead Sponsor

Trials

3

Recruited

180+

Data Management 365

Industry Sponsor

Trials

12

Recruited

4,300+

Keystat, LLC

Collaborator

Trials

3

Recruited

320+

Keystat, LLC

Industry Sponsor

Trials

3

Recruited

320+

Published Research Related to This Trial

Patients with idiopathic pericarditis showed a seasonal pattern of diagnosis, with all cases occurring between April and August, and had a lower prevalence of previous diseases compared to those with secondary pericarditis.

The study found that idiopathic pericarditis patients responded well to treatment with non-steroidal anti-inflammatory drugs (NSAIDs), with 82.6% receiving them, while only 8.2% of patients with secondary pericarditis were treated this way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pericarditis. Series of 84 consecutive cases. Zanettini, MT., Zanettini, JO., Zanettini, JP.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37380301/

Treatment of Idiopathic Recurrent Pericarditis With Goflikicept Goflikicept reduced the risk of recurrence compared with placebo. (Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2023.04.046

Treatment of Idiopathic Recurrent Pericarditis With Goflikicept Treatment with goflikicept prevented recurrences and maintained IRP remission with a favorable risk-benefit ratio.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04692766

Study to Evaluate the Efficacy and Safety of RPH-104 ... The goal of this study was to evaluate the Efficacy and Safety of RPH-104 Treatment in patients in comparison to placebo with Idiopathic Recurrent Pericarditis.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735109723055523

Treatment of Idiopathic Recurrent Pericarditis With Goflikicept Treatment with goflikicept prevented recurrences and maintained IRP remission with a favorable risk-benefit ratio.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05673902

Study of the Safety and Efficacy of RPH-104 in Preventing ... 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 ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05107934/efficacy-and-safety-of-rph-104-treatment-in-patients-with-recurrent-pericarditis

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