Phase 2/3 Study of KPL-387 in Recurrent Pericarditis

NCT07010159 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: KPL-387-C2112025-521933-10
• Study Type: interventional
• Target: 165
• Locations: 10 countries
• Sites: 52

Brief Summary

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

Conditions

Pericarditis Acute; Recurrent Pericarditis; Pericarditis

Keywords

Recurrence; Recurrent; Recurrent Pericarditis; KPL-387

Outcome Measures

Primary Outcomes (3)

• Phase 2: Time to Treatment Response by Week 24

  From Randomization up to Week 24

• Phase 3: Time to Pericarditis Recurrence

  From first administration of study drug in the RW Period

• Long-Term Extension: Annualized rate of Pericarditis Recurrence

  Up to 24 Months

Secondary Outcomes (30)

• Phase 2: Time to CRP Normalization (CRP ≤ 0.5 mg/dL) by Week 24

  From Randomization up to Week 24

• Phase 2: Time to Pain Response by Week 24

  From Randomization up to Week 24

• Phase 2: Percentage of Days With No or Minimal Pain (Numerical Rating Scale (NRS) ≤ 2) While on KPL-387 Treatment Over Time by Week 24

  From Randomization up to Week 24

• Phase 2: Proportion of Participants With Normalization of CRP (CRP ≤ 0.5 mg/dL) Over Time by Week 24

  From Randomization up to Week 24

• Phase 2: Time to resolution of pericarditis manifestations (i.e. echocardiogram [ECHO] abnormalities, electrocardiogram [ECG] abnormalities, and pericardial rub), when present at Baseline, by Week 16.

  From Randomization up to Week 16

Study Arms (7)

Phase 2 KPL-387 100mg SC q2wk

EXPERIMENTAL

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

Drug: KPL-387

Phase 2 KPL-387 100mg SC q4wk

EXPERIMENTAL

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.

Drug: KPL-387; Drug: Placebo

Phase 2 KPL-387 300mg SC q2wk

EXPERIMENTAL

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

Drug: KPL-387

Phase 2 KPL-387 300mg SC q4wk

EXPERIMENTAL

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.

Drug: KPL-387; Drug: Placebo

Phase 3 KPL-387 SC

EXPERIMENTAL

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.

Drug: KPL-387

Phase 3 Placebo SC

PLACEBO COMPARATOR

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

Drug: Placebo

Long-Term Extension

EXPERIMENTAL

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

Drug: KPL-387

Interventions

KPL-387 DRUG

administered by subcutaneous injection

Long-Term Extension; Phase 2 KPL-387 100mg SC q2wk; Phase 2 KPL-387 100mg SC q4wk; Phase 2 KPL-387 300mg SC q2wk; Phase 2 KPL-387 300mg SC q4wk; Phase 3 KPL-387 SC

Placebo DRUG

administered by subcutaneous injection

Phase 2 KPL-387 100mg SC q4wk; Phase 2 KPL-387 300mg SC q4wk; Phase 3 Placebo SC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 2 and 3: Has a diagnosis of recurrent pericarditis
• Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies
• Phase 2 and 3: Weighs at least 40 kg
• Phase 2: Taking NSAIDS and/or colchicine (in any combination)
• Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)

You may not qualify if:

• Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
• Phase 2 and 3: Has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study.
• Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
• Phase 2 and 3: Has a history of immunodeficiency.
• Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
• Phase 2 and 3: Has chest x-ray at Screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active TB infection or active infection.
• Phase 2 and 3: Has a history of malignancy of any organ system within the past 5 years before Screening (other than a successfully treated non metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
• Phase 2 and 3: Has a known or suspected current active infection or a history of chronic or recurrent infectious disease (\> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection.
• Phase 2 and 3: Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration.
• Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
• 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.

Sponsors & Collaborators

• Kiniksa Pharmaceuticals, GmbH: collaborator
• Kiniksa Pharmaceuticals International, plc: lead

Study Sites (52)

Investigational Site 018

Gilbert, Arizona, 85297, United States

RECRUITING

Investigational Site 030

Los Angeles, California, 90048, United States

RECRUITING

Investigational Site 008

San Francisco, California, 94158, United States

RECRUITING

Investigational Site 044

Santa Monica, California, 90404, United States

RECRUITING

Investigational Site 016

Westminster, Colorado, 80023, United States

RECRUITING

Investigational Site 001

Columbus, Georgia, 31904, United States

WITHDRAWN

Investigational Site 004

Chicago, Illinois, 60611, United States

RECRUITING

Investigational Site 014

Indianapolis, Indiana, 46184, United States

RECRUITING

Investigational Site 002

Overland Park, Kansas, 66221, United States

WITHDRAWN

Investigational Site 043

Baltimore, Maryland, 21287, United States

RECRUITING

Investigational Site 012

Rochester, Minnesota, 55905, United States

RECRUITING

Investigational Site 050

Kansas City, Missouri, 64111, United States

RECRUITING

Investigational Site 046

Kansas City, Missouri, 66160, United States

RECRUITING

Investigational Site 015

New York, New York, 10016, United States

RECRUITING

Investigational Site 022

New York, New York, 10032, United States

RECRUITING

Investigational Site 009

Cincinnati, Ohio, 45219, United States

RECRUITING

Investigational Site 003

Cleveland, Ohio, 44195, United States

RECRUITING

Investigational Site 005

Austin, Texas, 78705, United States

RECRUITING

Investigational Site 013

Houston, Texas, 77030, United States

RECRUITING

Investigational Site 042

Burlington, Vermont, 05401, United States

RECRUITING

Investigational Site 006

Charlottesville, Virginia, 22903, United States

RECRUITING

Investigational Site 023

Norfolk, Virginia, 23507, United States

RECRUITING

Investigational Site 045

Richmond, Virginia, 23284, United States

RECRUITING

Investigational Site 027

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

Investigational Site 028

Montpellier, 34090, France

RECRUITING

Investigational Site 021

Paris, 75013, France

RECRUITING

Investigational Site 036

Pessac, 33600, France

RECRUITING

Investigational Site 019

Poitiers, 86000, France

RECRUITING

Investigational Site 037

Toulouse, 31400, France

RECRUITING

Investigational Site 038

Toulouse, 31400, France

RECRUITING

Investigational Site 052

Dresden, 01069, Germany

RECRUITING

Investigational Site 034

Athens, 115 28, Greece

RECRUITING

Investigational Site 039

Nea Ionia, 142 33, Greece

RECRUITING

Investigational Site 032

Voula, 166 73, Greece

RECRUITING

Investigational Site 029

Genoa, 16132, Italy

RECRUITING

Investigational Site 040

Genoa, 16147, Italy

RECRUITING

Investigational Site 007

Milan, 20157, Italy

RECRUITING

Investigational Site 051

Padua, 35143, Italy

RECRUITING

Investigational Site 033

Udine, 33100, Italy

RECRUITING

Investigational Site 041

Varese, 21100, Italy

RECRUITING

Investigational Site 051

Warsaw, 02-097, Poland

RECRUITING

Investigational Site 031

Warsaw, 02-507, Poland

RECRUITING

Investigational Site 025

Belgrade, 11000, Serbia

RECRUITING

Investigational Site 026

Belgrade, 11040, Serbia

RECRUITING

Investigational Site 048

Barcelona, 08017, Spain

RECRUITING

Investigational Site 010

Barcelona, 8035, Spain

RECRUITING

Investigational Site 024

Madrid, 28850, Spain

RECRUITING

Investigational Site 011

Murcia, 30120, Spain

RECRUITING

Investigational Site 020

London, EC1A 7BE, United Kingdom

RECRUITING

Investigational Site 047

London, NW3 2QG, United Kingdom

RECRUITING

Investigational Site 035

London, SE1 7EH, United Kingdom

RECRUITING

Investigational Site 017

Southampton, SO17 1BJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pericarditis; Recurrence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Project Manager

CONTACT

781-431-9100; clinicaltrials@kiniksa.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 8, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 4, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3); FR (6); US (23); SE (2); ES (4); IT (6); PL (2); CA (1); DE (1); GB (4)