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

Phase 3RecruitingNCT07010159

Kiniksa Pharmaceuticals International, plc165 enrolled

Overview

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

This clinical trial is comprised of 3 separate study parts: Phase 2, Phase 3, and Long-Term Extension. The primary objective of Phase 2 is to evaluate how well different dose regimens of KPL-387 control the pain and inflammation of pericarditis in a group of participants experiencing an acute episode of recurrent pericarditis. This part of the study will confirm the KPL-387 dose regimen to be further tested in Phase 3 and the Long-Term Extension. 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 additional group of participants experiencing an acute episode of recurrent pericarditis. Participants who complete Phase 2 or Phase 3 may be eligible to participate in the Long-Term Extension. The primary objective of the Long-Term Extension is to assess the long-term efficacy of KPL-387 while maintaining long-term disease control. All of the study parts also have other objectives to learn about the safety, tolerability, concentration of KPL-387 in blood, and effects of KPL-387 on blood test markers of immune activity in recurrent pericarditis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

165

Conditions

Pericarditis Pericarditis Acute Recurrent Pericarditis

Interventions

KPL-387DRUG

administered by subcutaneous injection

PlaceboDRUG

administered by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * 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) Key Exclusion Criteria: * 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.

Locations (30)

Outcomes

Primary Outcomes

Phase 2: Time to Treatment Response by Week 24

Time frame: From Randomization up to Week 24

Phase 3: Time to Pericarditis Recurrence

Time frame: From first administration of study drug in the RW Period

Long-Term Extension: Annualized rate of Pericarditis Recurrence

Time frame: Up to 24 Months

Secondary Outcomes

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

Time frame: From Randomization up to Week 24

Phase 2: Time to Pain Response by Week 24

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: From Randomization up to Week 16

Phase 2: Change from Baseline in SF-36v2® Physical Component Summary score through Week 24.

Time frame: From Randomization up to Week 24

Phase 2: Change from Baseline in SF-36v2® Mental Component Summary score through Week 24.

Central Contacts

Clinical Project Manager

CONTACT

781-431-9100 clinicaltrials@kiniksa.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Investigational Site 018

Gilbert, Arizona, United States

RECRUITING

Investigational Site 030

Los Angeles, California, United States

RECRUITING

Investigational Site 008

San Francisco, California, United States

RECRUITING

Investigational Site 016

Westminster, Colorado, United States

RECRUITING

Investigational Site 001

Columbus, Georgia, United States

RECRUITING

Investigational Site 004

Chicago, Illinois, United States

RECRUITING

Investigational Site 014

Indianapolis, Indiana, United States

RECRUITING

Investigational Site 002

Overland Park, Kansas, United States

RECRUITING

Investigational Site 012

Rochester, Minnesota, United States

RECRUITING

Investigational Site 015

New York, New York, United States

RECRUITING

...and 20 more locations

Time frame: From Randomization to Week 24

Phase 2: Proportion of participants with Protocol-Defined Pericarditis Recurrence by Week 24.

Time frame: From Randomization to Week 24

Phase 2: Change from Baseline in CRP through Week 24.

Time frame: From Randomization up to Week 24

Phase 2: Change from Baseline in pericarditis pain NRS score through Week 24.

Time frame: From Randomization up to Week 24

Phase 2: Change from RI Baseline in SF-36v2® Mental Component Summary score through the end of the RI Period

Time frame: From Baseline up to the end of the RI Period

Phase 3: Time to Treatment Response by the end of the RI Period

Time frame: From Baseline up to end of the RI Period

Phase 3: Time to Clinical Response by the end of the RI Period

Time frame: From Baseline up to end of the RI Period

Phase 3: Time to Pain Response by end of the RI Period

Time frame: From Baseline up to end of the RI Period

Phase 3: Time to CRP normalization by the end of the RI Period

Time frame: From Baseline up to end of the RI Period

Phase 3: Change from RI Baseline in SF-36v2® Physical Component Summary score through the end of the RI Period.

Time frame: From Baseline up to end of the RI Period

Phase 3: Time to resolution of pericarditis manifestations (i.e., ECHO abnormalities, ECG abnormalities, and pericardial rub), when present at RI Baseline, by the end of the RI period.

Time frame: From Baseline up to end of the RI Period

Phase 3: Change from RI Baseline in daily pericarditis pain NRS score through the end of the RI Period.

Time frame: From Baseline up to end of the RI Period

Phase 3: Change from RI Baseline in CRP through the end of the RI Period.

Time frame: From Baseline up to end of the RI Period

Phase 3: Proportion of participants who maintained Clinical Response at RW Week 16.

Time frame: From Randomization up to RW Week 16

Phase 3: Percentage of days with no or minimal pericarditis pain through RW Week 16.

Time frame: From Randomization up to RW Week 16

Phase 3: Change from RW Baseline in SF-36v2® Physical Component Summary score at RW Week 16.

Time frame: From Randomization up to RW Week 16

Phase 3: Change from RW Baseline in SF-36v2® Mental Component Summary score at RW Week 16

Time frame: From Randomization up to RW Week 16

Phase 3: Change from RW Baseline in pain NRS score during the RW Period.

Time frame: From Randomization through the end of the RW Period

Phase 3: Change from RW Baseline in CRP during the RW Period

Time frame: From Randomization through the end of the RW Period

Long-Term Extension: Proportion of participants who maintained Clinical Response through the end of the LTE.

Time frame: Up to 24 months

Long-Term Extension: Percentage of days with no or minimal pericarditis pain through the end of the LTE Period.

Time frame: Up to 24 months

Long-Term Extension: Change from LTE Baseline in SF-36v2® Physical Component Summary score through the end of the LTE Period.

Time frame: Up to 24 months

Long-Term Extension: Change from LTE Baseline in SF-36v2® Mental Component Summary score through the end of the LTE Period.

Time frame: Up to 24 months

Long-Term Extension: Change from LTE baseline in pain NRS score through the end of the LTE Period.

Time frame: Up to 24 months