What side effects are associated with this type of intervention?

Common treatments for pericarditis include nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and corticosteroids. NSAIDs can cause gastrointestinal issues, renal impairment, and cardiovascular risks. Colchicine may lead to gastrointestinal disturbances such as diarrhea and nausea. Corticosteroids are associated with a range of side effects including weight gain, osteoporosis, hypertension, and increased risk of infections. Interleukin-1 inhibitors, like RPH-104, are being studied for their efficacy and safety; known side effects of similar agents include injection site reactions, increased risk of infections, and potential liver enzyme abnormalities.

What prior FDA approvals exist?

The FDA has approved several interleukin-1 (IL-1) inhibitors for the treatment of pericarditis. Notably, anakinra and canakinumab are IL-1 inhibitors that have been used for recurrent pericarditis. Anakinra, a short-acting IL-1 receptor antagonist, has shown efficacy in reducing inflammation and symptoms in patients with recurrent pericarditis. Canakinumab, a long-acting monoclonal antibody targeting IL-1 beta, has also been approved for use in patients with recurrent pericarditis who do not respond to conventional therapies. These treatments are similar to RPH-104, which is currently being studied for its efficacy and safety in treating recurrent pericarditis.

What other types of research exist?

Promising novel alternatives to RPH-104 for pericarditis patients in 2024 may include: <ol> <li>Canakinumab: Another interleukin-1 beta inhibitor, already approved for other inflammatory conditions, showing potential for pericarditis.</li> <li></li> </ol> Colchicine: While not novel, it remains a cornerstone in pericarditis treatment and may be used in combination with newer agents. 3. Anakinra: An interleukin-1 receptor antagonist, effective in various inflammatory conditions, could be considered for pericarditis. 4. Nintedanib: An antifibrotic agent used in fibrosing lung diseases, which may have potential in managing pericarditis with fibrotic complications.

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Other

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)

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 24 (of the rw period)

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

Musculoskeletal and connective tissue disorders

Pollakiuria

Skin and subcutaneous tissue disorders

Investigations

Respiratory, thoracic and mediastinal disorders

Psychiatric disorders

Ear and labyrinth disorders

100%

80%

60%

40%

20%

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

0 / 11Eligibility criteria met

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.