Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-06 @ 10:15 PM
Study NCT ID:
NCT07010159
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010493', 'term': 'Pericarditis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 2: Time to Treatment Response by Week 24', 'timeFrame': 'From Randomization up to Week 24'}, {'measure': 'Phase 3: Time to Pericarditis Recurrence', 'timeFrame': 'From first administration of study drug in the RW Period'}, {'measure': 'Long-Term Extension: Annualized rate of Pericarditis Recurrence', 'timeFrame': 'Up to 24 Months'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Time to CRP Normalization (CRP ≤ 0.5 mg/dL) by Week 24', 'timeFrame': 'From Randomization up to Week 24'}, {'measure': 'Phase 2: Time to Pain Response by Week 24', 'timeFrame': 'From Randomization up to Week 24'}, {'measure': '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', 'timeFrame': 'From Randomization up to Week 24'}, {'measure': 'Phase 2: Proportion of Participants With Normalization of CRP (CRP ≤ 0.5 mg/dL) Over Time by Week 24', 'timeFrame': 'From Randomization up to Week 24'}, {'measure': '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.', 'timeFrame': 'From Randomization up to Week 16'}, {'measure': 'Phase 2: Change from Baseline in SF-36v2® Physical Component Summary score through Week 24.', 'timeFrame': 'From Randomization up to Week 24'}, {'measure': 'Phase 2: Change from Baseline in SF-36v2® Mental Component Summary score through Week 24.', 'timeFrame': 'From Randomization to Week 24'}, {'measure': 'Phase 2: Proportion of participants with Protocol-Defined Pericarditis Recurrence by Week 24.', 'timeFrame': 'From Randomization to Week 24'}, {'measure': 'Phase 2: Change from Baseline in CRP through Week 24.', 'timeFrame': 'From Randomization up to Week 24'}, {'measure': 'Phase 2: Change from Baseline in pericarditis pain NRS score through Week 24.', 'timeFrame': 'From Randomization up to Week 24'}, {'measure': 'Phase 2: Change from RI Baseline in SF-36v2® Mental Component Summary score through the end of the RI Period', 'timeFrame': 'From Baseline up to the end of the RI Period'}, {'measure': 'Phase 3: Time to Treatment Response by the end of the RI Period', 'timeFrame': 'From Baseline up to end of the RI Period'}, {'measure': 'Phase 3: Time to Clinical Response by the end of the RI Period', 'timeFrame': 'From Baseline up to end of the RI Period'}, {'measure': 'Phase 3: Time to Pain Response by end of the RI Period', 'timeFrame': 'From Baseline up to end of the RI Period'}, {'measure': 'Phase 3: Time to CRP normalization by the end of the RI Period', 'timeFrame': 'From Baseline up to end of the RI Period'}, {'measure': 'Phase 3: Change from RI Baseline in SF-36v2® Physical Component Summary score through the end of the RI Period.', 'timeFrame': 'From Baseline up to end of the RI Period'}, {'measure': '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.', 'timeFrame': 'From Baseline up to end of the RI Period'}, {'measure': 'Phase 3: Change from RI Baseline in daily pericarditis pain NRS score through the end of the RI Period.', 'timeFrame': 'From Baseline up to end of the RI Period'}, {'measure': 'Phase 3: Change from RI Baseline in CRP through the end of the RI Period.', 'timeFrame': 'From Baseline up to end of the RI Period'}, {'measure': 'Phase 3: Proportion of participants who maintained Clinical Response at RW Week 16.', 'timeFrame': 'From Randomization up to RW Week 16'}, {'measure': 'Phase 3: Percentage of days with no or minimal pericarditis pain through RW Week 16.', 'timeFrame': 'From Randomization up to RW Week 16'}, {'measure': 'Phase 3: Change from RW Baseline in SF-36v2® Physical Component Summary score at RW Week 16.', 'timeFrame': 'From Randomization up to RW Week 16'}, {'measure': 'Phase 3: Change from RW Baseline in SF-36v2® Mental Component Summary score at RW Week 16', 'timeFrame': 'From Randomization up to RW Week 16'}, {'measure': 'Phase 3: Change from RW Baseline in pain NRS score during the RW Period.', 'timeFrame': 'From Randomization through the end of the RW Period'}, {'measure': 'Phase 3: Change from RW Baseline in CRP during the RW Period', 'timeFrame': 'From Randomization through the end of the RW Period'}, {'measure': 'Long-Term Extension: Proportion of participants who maintained Clinical Response through the end of the LTE.', 'timeFrame': 'Up to 24 months'}, {'measure': 'Long-Term Extension: Percentage of days with no or minimal pericarditis pain through the end of the LTE Period.', 'timeFrame': 'Up to 24 months'}, {'measure': 'Long-Term Extension: Change from LTE Baseline in SF-36v2® Physical Component Summary score through the end of the LTE Period.', 'timeFrame': 'Up to 24 months'}, {'measure': 'Long-Term Extension: Change from LTE Baseline in SF-36v2® Mental Component Summary score through the end of the LTE Period.', 'timeFrame': 'Up to 24 months'}, {'measure': 'Long-Term Extension: Change from LTE baseline in pain NRS score through the end of the LTE Period.', 'timeFrame': 'Up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recurrence', 'Recurrent', 'Recurrent Pericarditis', 'KPL-387'], 'conditions': ['Pericarditis', 'Pericarditis Acute', 'Recurrent Pericarditis']}, 'descriptionModule': {'briefSummary': 'This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Phase 2 and 3: Has a diagnosis of recurrent pericarditis\n* Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies\n* Phase 2 and 3: Weighs at least 40 kg\n* Phase 2: Taking NSAIDS and/or colchicine (in any combination)\n* Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)\n\nKey Exclusion Criteria:\n\n* Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.\n* 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.\n* Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.\n* Phase 2 and 3: Has a history of immunodeficiency.\n* Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.\n* 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.\n* 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).\n* 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.\n* 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.\n* Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).\n* 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."}, 'identificationModule': {'nctId': 'NCT07010159', 'briefTitle': 'Phase 2/3 Study of KPL-387 in Recurrent Pericarditis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kiniksa Pharmaceuticals International, plc'}, 'officialTitle': 'A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis', 'orgStudyIdInfo': {'id': 'KPL-387-C211'}, 'secondaryIdInfos': [{'id': '2025-521933-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2 KPL-387 100mg SC q2wk', 'description': 'In Phase 2 Treatment Period KPL-387 will be administered by subcutaneous (SC) injection every 2 weeks (q2wk) through Week 22.', 'interventionNames': ['Drug: KPL-387']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 KPL-387 100mg SC q4wk', 'description': 'In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration every 4 weeks (q4wk) while maintaining treatment concealment.', 'interventionNames': ['Drug: KPL-387', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 KPL-387 300mg SC q2wk', 'description': 'In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22.', 'interventionNames': ['Drug: KPL-387']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 KPL-387 300mg SC q4wk', 'description': 'In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration q4wk while maintaining treatment concealment.', 'interventionNames': ['Drug: KPL-387', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 3 KPL-387 SC', 'description': 'Run-In (RI) Period: participants receive single-blind KPL-387\n\nRandomized Withdrawal (RW) Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded KPL-387.', 'interventionNames': ['Drug: KPL-387']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 3 Placebo SC', 'description': 'RW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Long-Term Extension', 'description': 'Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387.', 'interventionNames': ['Drug: KPL-387']}], 'interventions': [{'name': 'KPL-387', 'type': 'DRUG', 'description': 'administered by subcutaneous injection', 'armGroupLabels': ['Long-Term Extension', 'Phase 2 KPL-387 100mg SC q2wk', 'Phase 2 KPL-387 100mg SC q4wk', 'Phase 2 KPL-387 300mg SC q2wk', 'Phase 2 KPL-387 300mg SC q4wk', 'Phase 3 KPL-387 SC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'administered by subcutaneous injection', 'armGroupLabels': ['Phase 2 KPL-387 100mg SC q4wk', 'Phase 2 KPL-387 300mg SC q4wk', 'Phase 3 Placebo SC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 008', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 001', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 004', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46184', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 014', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66221', 'city': 'Overland Park', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 002', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 012', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 009', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 003', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 005', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 013', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22903', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 006', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '20157', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Investigational Site 007', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '8035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site 010', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '30120', 'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site 011', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'centralContacts': [{'name': 'Clinical Project Manager', 'role': 'CONTACT', 'email': 'clinicaltrials@kiniksa.com', 'phone': '781-431-9100'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kiniksa Pharmaceuticals International, plc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kiniksa Pharmaceuticals, GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}