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Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis

NCT03737110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-09-06

Study results available
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Summary

The primary objective of this study was to assess the efficacy of rilonacept treatment in participants with recurrent pericarditis.

Conditions

  • Recurrent Pericarditis

Interventions

DRUG

Rilonacept

Rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥12 and \<18 years old) SC , followed by 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and \<18 years old) injections once weekly

DRUG

Placebo

Placebo SC injections once weekly

Sponsors & Collaborators

  • Kiniksa Pharmaceuticals (UK), Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Operations Study Director · Kiniksa Pharmaceuticals (UK), Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2020-05-29
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Israel
  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03737110 on ClinicalTrials.gov