Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-01 @ 12:16 AM
Study NCT ID:
NCT06980805
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2025-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008178', 'term': 'Lupus Erythematosus, Cutaneous'}, {'id': 'D008179', 'term': 'Lupus Erythematosus, Discoid'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12'}, {'measure': 'Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12'}, {'measure': 'Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Cutaneous Lupus Erythematosus', 'Subacute Cutaneous Lupus Erythematosus', 'IMVT-1402'], 'conditions': ['Subacute Cutaneous Lupus Erythematosus', 'Chronic Cutaneous Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.\n\nThe study will consist of 3 periods:\n\nPeriod 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks.\n\nPeriod 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks.\n\nPeriod 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.', 'detailedDescription': 'The total study duration per participant is approximately 61 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.\n* Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with a CLASI-A score of ≥8 and \\<10 are eligible if the score does not include alopecia and/or mucous membrane lesions.\n* Have active CLE despite an adequate trial of conventional therapies.\n* Are positive for at least one autoantibody at Screening.\n\nExclusion Criteria:\n\n* Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE.\n* Have rapidly progressive nephritis.\n* Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT06980805', 'briefTitle': 'A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunovant Sciences GmbH'}, 'officialTitle': 'A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations', 'orgStudyIdInfo': {'id': 'IMVT-1402-2701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Period 1: Placebo', 'description': 'Matching placebo for 12 weeks in Period 1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'IMVT-1402 Subcutaneous (SC) Once weekly (QW)', 'description': '* Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks\n* Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks\n* Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks', 'interventionNames': ['Drug: IMVT-1402']}], 'interventions': [{'name': 'IMVT-1402', 'type': 'DRUG', 'description': 'Dose 1 or Dose 2 SC QW', 'armGroupLabels': ['IMVT-1402 Subcutaneous (SC) Once weekly (QW)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo SC QW', 'armGroupLabels': ['Period 1: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207-4780', 'city': 'Anniston', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 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