Transition to KPL-387 Monotherapy Dosing & Administration Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Kiniksa Pharmaceuticals International, plc
Study ID
NCT07288216
Phase
PHASE2
Status
Recruiting
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Conditions

  • Heart Diseases
  • Pericarditis
  • Recurrent Pericarditis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • KPL-387 — DRUG
    administered by subcutaneous injection

Study Details

The primary objective of this study is to characterize the efficacy and safety of dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis on standard therapies.

Key Dates

Start date
Mar 25, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Posology KPL-387
    In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16.
  • Experimental: Long-Term Extension
    Participants from Posology Study who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first.

Primary Outcome Measure

Posology: Proportion of participants free from Pericarditis Recurrence by Week 16 [ Time Frame: From first administration of study drug up to Week 16 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Investigational Site 031PhoenixArizona85054-
Investigational Site 014Los AngelesCalifornia90048-
Investigational Site 002Santa MonicaCalifornia90404-
Investigational Site 013ChicagoIllinois60611-
Investigational Site 025BaltimoreMaryland21287-
Investigational Site 028RochesterMinnesota55905-
Investigational Site 003New YorkNew York10032-
Investigational Site 011New YorkNew York10016-
Investigational Site 009CincinnatiOhio45219-
Investigational Site 005AustinTexas78705-
Investigational Site 006HoustonTexas77030-
Investigational Site 004CharlottesvilleVirginia22903-
Investigational Site 001NorfolkVirginia23507-
Investigational Site 008RichmondVirginia23284-

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