KPL-387 for Pericarditis

Recruiting at 6 trial locations

Overseen By Clinical Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Kiniksa Pharmaceuticals International, plc

Must be taking: NSAIDs, Colchicine, Glucocorticoids

Disqualifiers: Tuberculosis, Immunodeficiency, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests KPL-387, an experimental treatment, to determine its safety and effectiveness for people with recurrent pericarditis, a condition involving repeated inflammation of the sac around the heart. Participants will receive varying doses of KPL-387 through injections to identify the most effective dose. Individuals who have experienced pericarditis symptoms despite using standard treatments like NSAIDs and colchicine may be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. In fact, participants in Phase 2 and 3 are required to be taking NSAIDs, colchicine, and/or glucocorticoids. It's best to discuss your specific medications with the trial team.

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

Research has shown that KPL-387 has been tested for safety in humans, specifically for treating recurrent pericarditis, a condition where the heart's lining becomes repeatedly inflamed. Earlier studies, including initial trials, demonstrated that KPL-387 is administered as an injection under the skin. This treatment is typically given once a month, indicating it is manageable and generally well-tolerated by patients.

Some early findings from these studies suggest that KPL-387 can be used safely in patients with recurrent pericarditis. However, detailed information about any side effects or adverse events from these studies is not available in the sources provided. Since the treatment is now in later stages of trials (Phase 2 and Phase 3), KPL-387 has passed the initial safety checks required in early trials.

In summary, while detailed safety data is lacking, the progression to later trial phases suggests that KPL-387 is considered safe enough for continued testing in humans. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for pericarditis?

Most treatments for pericarditis, like colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs), work by reducing inflammation. But KPL-387 works differently, targeting the biological pathways that directly contribute to the inflammation process. Researchers are excited about KPL-387 because it is administered via subcutaneous injection, potentially offering a more targeted approach with fewer side effects than current oral medications. Additionally, the option of different dosing schedules (every two or four weeks) provides flexibility that might better suit patients' needs, improving adherence and outcomes.

What evidence suggests that KPL-387 might be an effective treatment for pericarditis?

Research has shown that KPL-387 might help treat recurring pericarditis, a condition where the heart's lining becomes inflamed. Early results suggest it could reduce the likelihood of recurrence. In this trial, participants will receive KPL-387 as a subcutaneous injection, with various dosing schedules tested. Initial findings indicate that KPL-387 could be a promising option for people with this condition. Ongoing studies aim to confirm these encouraging results. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals who have recurrent pericarditis and still experience symptoms despite standard treatments. Participants must weigh at least 40 kg. Those in Phase 2 should be on NSAIDs and/or colchicine, while those in Phase 3 may also be taking glucocorticoids.

Inclusion Criteria

My pericarditis symptoms persist despite standard treatments.

I weigh at least 40 kg.

I am currently taking NSAIDs, colchicine, or both.

Exclusion Criteria

Phase 2 and 3: In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations

My recent chest X-ray showed signs of cancer or possible TB infection.

I have had an organ transplant, not including a corneal transplant over 3 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 2 Treatment

Participants receive KPL-387 by subcutaneous injection every 2 or 4 weeks through Week 22 to evaluate dose regimens for controlling pain and inflammation of pericarditis

22 weeks

Phase 3 Treatment

Participants receive KPL-387 or placebo in a randomized withdrawal design to confirm efficacy for treatment and reduction in risk of recurrence

Duration not specified

Long-Term Extension

Participants who complete Phase 2 or Phase 3 may continue to receive KPL-387 to assess long-term efficacy and disease control

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KPL-387

Trial Overview The study aims to determine the effectiveness and safety of KPL-387 as a treatment for recurrent pericarditis compared to a placebo. It's designed to see if this new medication can help where other standard therapies haven't been fully effective.

How Is the Trial Designed?

Group I: Phase 3 KPL-387 SC Experimental Treatment 1 Intervention

Run-In (RI) Period: participants receive single-blind KPL-387 Randomized Withdrawal (RW) Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded KPL-387.

Group II: Phase 2 KPL-387 300mg SC q4wk Experimental Treatment 2 Interventions

In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration q4wk while maintaining treatment concealment.

Group III: Phase 2 KPL-387 300mg SC q2wk Experimental Treatment 1 Intervention

In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22.

Group IV: Phase 2 KPL-387 100mg SC q4wk Experimental Treatment 2 Interventions

In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration every 4 weeks (q4wk) while maintaining treatment concealment.

Group V: Phase 2 KPL-387 100mg SC q2wk Experimental Treatment 1 Intervention

In Phase 2 Treatment Period KPL-387 will be administered by subcutaneous (SC) injection every 2 weeks (q2wk) through Week 22.

Group VI: Long-Term Extension Experimental Treatment 1 Intervention

Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387.

Group VII: Phase 3 Placebo SC Placebo Group 1 Intervention

RW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo.

Who Is Running the Clinical Trial?

Kiniksa Pharmaceuticals International, plc

Lead Sponsor

Trials

3

Recruited

1,500+

Kiniksa Pharmaceuticals, GmbH

Industry Sponsor

Trials

1

Recruited

200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07010159

Phase 2/3 Study of KPL-387 in Recurrent Pericarditis The primary objective of Phase 3 is to confirm the efficacy of KPL-387 for the treatment of recurrent pericarditis and reduction in risk of recurrence in an ...

2. kiniksa.gcs-web.com kiniksa.gcs-web.com/news-releases/news-release-details/kiniksa-pharmaceuticals-announces-trial-design-planned-phase-23

Press Release Details - Kiniksa Pharmaceuticals The primary efficacy endpoint is time to first-adjudicated pericarditis recurrence during the RW period. Participants in the RW period may be ...

3. investors.kiniksa.com investors.kiniksa.com/news-releases/news-release-details/kiniksa-pharmaceuticals-announces-development-kpl-387-recurrent

Press Release Details Topline data from the SAD portion of the Phase 1 trial of KPL-387 support potential monthly SC dosing in recurrent pericarditis. Kiniksa has ...

4. myocarditisfoundation.org myocarditisfoundation.org/clinical-trial/

Phase 2/​3 Study of KPL-387 in Recurrent Pericarditis Brief Summary. This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352906725002441

Pericarditis at the crossroads: Unlocking the next wave of ... KPL-387 is designed for monthly dosing and is planned to enter a phase 2/3 trial for steroid-dependent recurrent pericarditis in 2025 [27]. If successful, it ...

6. myocarditisfoundation.org myocarditisfoundation.org/condition/pericarditis/

Pericarditis Archives Brief Summary. This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.