Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-06 @ 8:26 PM
Study NCT ID:
NCT06548360
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)', 'timeFrame': 'Week 24', 'description': '≥75% improvement in facial Vitiligo Area Scoring Index.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)', 'timeFrame': 'Week 24', 'description': '≥50% improvement in facial Vitiligo Area Scoring Index.'}, {'measure': 'Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)', 'timeFrame': 'Week 24', 'description': '≥90% improvement in facial Vitiligo Area Scoring Index.'}, {'measure': 'Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)', 'timeFrame': 'Week 24', 'description': '≥50% improvement in total body Vitiligo Area Scoring Index.'}, {'measure': 'Percentage change from baseline in F-BSA', 'timeFrame': 'Week 24', 'description': 'Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.'}, {'measure': 'Number of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Week 52 and 30 days', 'description': 'TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.'}, {'measure': 'Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)', 'timeFrame': 'Week 52', 'description': '≥50% improvement in facial Vitiligo Area Scoring Index.'}, {'measure': 'Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)', 'timeFrame': 'Week 52', 'description': '≥75% improvement in facial Vitiligo Area Scoring Index.'}, {'measure': 'Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)', 'timeFrame': 'Week 52', 'description': '≥90% improvement in facial Vitiligo Area Scoring Index.'}, {'measure': 'Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)', 'timeFrame': 'Week 52', 'description': '≥50% improvement in total body Vitiligo Area Scoring Index.'}, {'measure': 'Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25)', 'timeFrame': 'Week 24 and Week 52', 'description': '≥25% improvement in total body Vitiligo Area Scoring Index.'}, {'measure': 'Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)', 'timeFrame': 'Week 24 and Week 52', 'description': '≥75% improvement in total body Vitiligo Area Scoring Index'}, {'measure': 'Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)', 'timeFrame': 'Week 24 and Week 52', 'description': '≥90% improvement in total body Vitiligo Area Scoring Index'}, {'measure': 'Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations', 'timeFrame': 'Weeks 6, 24, 30 and 52', 'description': 'Trough is defined as the concentration reached by a drug immediately before the next dose is administered.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NonSegmental Vitiligo', 'pediatric'], 'conditions': ['NonSegmental Vitiligo']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://incyteclinicaltrials.com/studies/incb18424-312', 'label': 'A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI.\n* Total body vitiligo area does not exceed 10% BSA.\n* Pigmented hair within some of the areas of vitiligo on the face.\n* Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit.\n* For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last application of study cream.\n\nExclusion Criteria:\n\n* Diagnosis of other forms of vitiligo (eg, segmental).\n* Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).\n* Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.\n* Prior or current use of depigmentation treatments (eg, monobenzone).\n* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Use of protocol-defined treatments within the indicated washout period before baseline.\n* Current or previous use of JAK inhibitors, systemic or topical.\n* Protocol-defined clinically significant abnormal laboratory values at screening.\n* BMI-for-age \\< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.\n* Pregnant or lactating participants or those considering pregnancy during the period of their study participation.\n* In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations.\n* Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.\n* Employees of the sponsor or investigator or are otherwise dependents of them.\n* Known allergy or reaction to any component of the study cream formulation.\n\nOther protocol-defined Inclusion/Exclusion Criteria may apply."}, 'identificationModule': {'nctId': 'NCT06548360', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo', 'orgStudyIdInfo': {'id': 'INCB18424-312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ruxolitinib 1.5 % Cream', 'description': 'Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.', 'interventionNames': ['Drug: Ruxolitinib Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Cream', 'description': 'Participants received vehicle cream, applied topically to the affected area as defined by the protocol.', 'interventionNames': ['Drug: Vehicle Cream']}], 'interventions': [{'name': 'Ruxolitinib Cream', 'type': 'DRUG', 'otherNames': ['INCB018424 Phosphate Cream'], 'description': 'Ruxolitinib cream applied topically to the affected area as a thin film twice daily.', 'armGroupLabels': ['Ruxolitinib 1.5 % Cream']}, {'name': 'Vehicle Cream', 'type': 'DRUG', 'description': 'Matching vehicle cream applied topically to the affected area as a thin film twice daily.', 'armGroupLabels': ['Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 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These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThe trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency', 'accessCriteria': 'Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}