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Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387

ConditionsPericarditisPericarditis AcuteRecurrent Pericarditis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKiniksa Pharmaceuticals International, plc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • KPL-387

    Drug

    administered by subcutaneous injection

  • Placebo

    Drug

    administered by subcutaneous injection

Treatment groups

325 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Phase 2 KPL-387 100mg SC q2wkExperimental treatment 1 intervention
Group B: Phase 2 KPL-387 100mg SC q4wkExperimental treatment 2 interventions
Group C: Phase 2 KPL-387 300mg SC q2wkExperimental treatment 1 intervention
Group D: Phase 2 KPL-387 300mg SC q4wkExperimental treatment 2 interventions
Group E: Phase 3 KPL-387 SCExperimental treatment 1 intervention
Group F: Phase 3 Placebo SCPlacebo comparator 1 intervention
Group G: Long-Term ExtensionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 2: Time to Treatment Response by Week 24

Time frame
From Baseline up to Week 24
2

Phase 3: Time to Pericarditis Recurrence

Time frame
From Baseline in the RW Period
3

Long-Term Extension: Annualized rate of Pericarditis Recurrence

Time frame
Up to 24 Months

Secondary outcomes

1

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

Time frame
From Baseline up to Week 24
2

Phase 2: Time to Pain Response by Week 24

Time frame
From Baseline up to Week 24
3

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 Baseline up to Week 24
4

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

Time frame
From Baseline up to Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kiniksa Pharmaceuticals International, plc

Lead sponsor

Kiniksa Pharmaceuticals, GmbH

Collaborator

Source ClinicalTrials.gov
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