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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug RPH-104 for treating recurrent pericarditis?

The effectiveness of RPH-104 for recurrent pericarditis may be supported by similar treatments like rilonacept, which has shown to improve quality of life, sleep, and reduce symptoms in patients with recurrent pericarditis by targeting interleukin-1, a protein involved in inflammation. ^{1 2 3 4 5}

Is RPH-104 safe for humans?

The safety of treatments similar to RPH-104, like rilonacept and anakinra, has been evaluated in clinical trials for recurrent pericarditis, showing a favorable safety profile with monitoring of adverse events, physical exams, and lab tests. ^{1 5 6 7 8}

How does the drug RPH-104 differ from other treatments for recurrent pericarditis?

RPH-104 is unique because it targets interleukin-1 (IL-1), a key player in the inflammation process of recurrent pericarditis, similar to rilonacept and anakinra, which are also IL-1 blockers. This approach is different from traditional treatments like NSAIDs, colchicine, and corticosteroids, which do not specifically target IL-1. ^{3 5 6 8 9}

Research Team

Yan Lavrovsky

Principal Investigator

R-Pharm Overseas, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence: The AIRTRIP Randomized Clinical Trial. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Interleukin-1 Trap Rilonacept Improved Health-Related Quality of Life and Sleep in Patients With Recurrent Pericarditis: Results From the Phase 3 Clinical Trial RHAPSODY. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Recurrent pericarditis. [2017]

4. Brazil pubmed.ncbi.nlm.nih.gov

Pericarditis. Series of 84 consecutive cases. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Quantitative assessment of pericardial delayed hyperenhancement helps identify patients with ongoing recurrences of pericarditis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Interleukin-1 blockers for the treatment of recurrent pericarditis: pathophysiology, patient reported outcomes and perspectives. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

RHAPSODY: Rationale for and design of a pivotal Phase 3 trial to assess efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β trap, in patients with recurrent pericarditis. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of rilonacept for recurrent pericarditis: results from a phase II clinical trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Rilonacept for the treatment of recurrent pericarditis. [2022]