Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-05 @ 6:15 PM
Study NCT ID:
NCT06685835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-12
First Post:
2024-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619932', 'term': 'brensocatib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16', 'timeFrame': 'Baseline and Week 16'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16', 'timeFrame': 'Week 16'}, {'measure': 'Percentage of Participants Achieving HiSCR75 at Week 16', 'timeFrame': 'Week 16'}, {'measure': "Percentage of Participants Achieving ≥2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16", 'timeFrame': 'Week 16'}, {'measure': 'Change From Baseline in Draining Tunnel Count at Week 16', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Percentage of Participants Remaining Free from HS Flare by Week 16', 'timeFrame': 'Week 16'}, {'measure': 'Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Percentage of Participants Achieving IHS4-55 at Week 16', 'timeFrame': 'Week 16'}, {'measure': 'Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16', 'timeFrame': 'Baseline and Week 16'}, {'measure': 'Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3', 'timeFrame': 'Week 16'}, {'measure': 'Number of Participants who Experienced at Least One Adverse Event (AE)', 'timeFrame': 'Up to Week 56'}, {'measure': 'Plasma Concentration of Brensocatib', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Week 56'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HS'], 'conditions': ['Hidradenitis Suppurativa']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of HS (confirmed by a dermatologist), with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit.\n* Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit.\n* HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits.\n\nExclusion Criteria:\n\n* Draining tunnel count of ≥20 at the Baseline Visit.\n* Surgical or laser intervention for an HS lesion during the Screening Period.\n* Clinical diagnosis of Papillon-Lefèvre Syndrome.\n* Participants with an absolute neutrophil count \\<1,000/mm3 at the Screening Visit.\n* Participants having active liver disease or hepatic dysfunction.\n* Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.\n* Received systemic (intravenous or orally \\[PO\\]) antibiotic therapy within 8 weeks before the Baseline Visit\n\n a. Doxycycline or minocycline up to 100 mg twice daily is permitted provided the dosing regimen being stable for at least 8 weeks before the Baseline Visit and is expected to continue.\n* Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.\n* Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.\n* Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.\n* Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.\n* Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.\n* Received any immunomodulatory agents within 4 weeks before the Baseline Visit.\n\nNote: Other Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06685835', 'acronym': 'CEDAR', 'briefTitle': 'A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Insmed Incorporated'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study', 'orgStudyIdInfo': {'id': 'INS1007-231'}, 'secondaryIdInfos': [{'id': '2024-515959-38-00', 'type': 'OTHER', 'domain': 'EU Trial (CTIS) Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brensocatib 10 mg', 'description': 'Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.', 'interventionNames': ['Drug: Brensocatib']}, {'type': 'EXPERIMENTAL', 'label': 'Brensocatib 40 mg', 'description': 'Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.', 'interventionNames': ['Drug: Brensocatib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Followed by Brensocatib 10 mg', 'description': 'Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks.', 'interventionNames': ['Drug: Brensocatib', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Followed by Brensocatib 40 mg', 'description': 'Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.', 'interventionNames': ['Drug: Brensocatib', 'Drug: Placebo']}], 'interventions': [{'name': 'Brensocatib', 'type': 'DRUG', 'otherNames': ['INS1007'], 'description': 'Film-coated Oral tablet', 'armGroupLabels': ['Brensocatib 10 mg', 'Brensocatib 40 mg', 'Placebo Followed by Brensocatib 10 mg', 'Placebo Followed by Brensocatib 40 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Film-coated Oral tablet', 'armGroupLabels': ['Placebo Followed by Brensocatib 10 mg', 'Placebo Followed by Brensocatib 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054-4502', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'USA001', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'USA007', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'USA026', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'USA027', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33063', 'city': 'Margate', 'state': 'Florida', 'country': 'United States', 'facility': 'USA021', 'geoPoint': {'lat': 26.24453, 'lon': -80.20644}}, 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