CompletedPhase 2

A Pilot Study of KPL-914 in Recurrent Pericarditis

United States26 participantsStarted 2018-01-24

Plain-language summary

The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis.

Who can participate

Age range6 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for All Participants: * Has given consent (or assent, if applicable) and signed an Informed Consent Form (ICF) (or informed assent form, if applicable). * Male or female, of any ethnic origin. * 6 to 75 years of age, inclusive. * If used, has received non-steroidal anti-inflammatory drugs (NSAIDs), and/or colchicine and/or corticosteroids (in any combination) at stable dose levels for at least 7 days prior to study drug dosing (although stable doses for a shorter period will be acceptable if in the opinion of the Investigator, in consultation with the Sponsor, a shorter period of stability is not anticipated to alter the baseline CRP values) and is anticipated to continue these concomitant medications at these dose levels for the duration of the active Treatment Period. * If female of child-bearing potential, must be nonpregnant and nonlactating and must agree to use an effective method of contraception, e.g., hormonal contraception or double-barrier birth control. * Is able to adequately maintain a medication diary. * Agrees to refrain from making any new, major life-style changes that may affect pericarditis symptoms (e.g., starting a new diet or changing exercise pattern) from the time of signature of the ICF (or informed assent form, if applicable) to the End-of-Trial Visit. Parts 1, 2 and 4: Subjects eligible for Parts 1, 2 and 4 have to present during a symptomatic episode of recurrent idiopathic pericarditis (RIP; Parts 1 and 2) and post pericardi…

What they're measuring

Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels

Timeframe: Screening Visit 1 (Day -3 to Day 0), Screening Visit 2 (Day -3 to Day 0), Day 0, Baseline (defined as the last non-missing assessment prior to the first study drug administration)

Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels

Timeframe: Baseline, Treatment Period (TP) Weeks 2, 3, 4, 5, 6, TP Interval Evaluation (between Weeks 3-4), End of TP (up to Week 6), Extension Period (EP): Months 1, 2, 3, 4, EP Interval Evaluation (between Weeks 15-20), Final Visit (up to Week 25)

Parts 1, 2 and 4: Pretreatment Pain NRS Scores

Timeframe: Prescreening, Screening Visit 1 (Day -3 to Day 0), Screening Visit 2 (Day -3 to Day 0), Day 0, Baseline (defined as the last non-missing assessment prior to the first study drug administration)

Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores

Timeframe: Baseline, Treatment Period (TP) Day 3, Weeks 2, 3, TP Interval Evaluation (between Weeks 3-4), 4, 5, 6, End of TP (up to Week 6), Extension Period (EP): Months 1, 2, 3, 4, EP Interval Evaluation (between Weeks 15-20), Final Visit (up to Week 25)

Parts 3 and 5: Change From Baseline Over Time in CRP Levels

Timeframe: Baseline, TP Weeks 2, 3, Interval Evaluation Visit (Weeks 3-4), 4, 5, 6, End of TP Visit (Week 6), EP Months 1, 2, 3, 4, EP Interval Evaluation Visit (Week 15-Week 20), Final Visit (up to EP Month 4)

Trial details

NCT IDNCT03980522

SponsorKiniksa Pharmaceuticals (UK), Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-17

Results submitted2021-04-12

View on ClinicalTrials.gov More Recurrent Pericarditis trials