Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:51 AM
Study NCT ID:
NCT07437560
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017496', 'term': 'Hypopigmentation'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079282', 'term': 'melanotan-II'}, {'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigational product and placebo are identical in appearance and packaging. Randomization codes are held by an unblinded pharmacist/third party. Outcome assessments are performed by blinded evaluators using standardized photographs and scoring rules.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized 1:1 to investigational Melanotan II or matching placebo while receiving standardized NB-UVB phototherapy for 24 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-02-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Vitiligo Area Scoring Index (VASI) total score', 'timeFrame': '24 Weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants achieving', 'timeFrame': '24 Weeks', 'description': '50% improvement in VASI (VASI50). 2) Time to first clinically detectable repigmentation in target lesions (standardized photography). 3) Change from baseline in objective pigmentation (melanin index) in predefined target lesions (colorimetry). 4) Change from baseline in Dermatology Life Quality Index (DLQI). 5) Incidence and severity of adverse events (AEs) and clinically significant dermatologic changes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanotan II', 'MT-II', 'melanocortin receptor agonist', 'MC1R', 'melanogenesis', 'skin pigmentation', 'repigmentation', 'vitiligo', 'narrowband UV-B', 'phototherapy'], 'conditions': ['NonSegmental Vitiligo', 'Nonsegmental Vitiligo (Stable)']}, 'descriptionModule': {'briefSummary': 'This example interventional study record describes a randomized Phase 2 clinical trial evaluating investigational Melanotan II (MT-II) as an adjunct to standard NB-UVB phototherapy for repigmentation in adults with stable nonsegmental vitiligo.', 'detailedDescription': 'Vitiligo is characterized by acquired depigmented macules and patches due to the loss of functional melanocytes. Narrowband UV-B (NB-UVB) phototherapy is a common treatment that can promote repigmentation, but responses may be incomplete and can take months. Melanotan II (MT-II) is a synthetic cyclic melanocortin receptor agonist with activity at melanocortin receptors involved in melanogenesis (pigment production). This example trial evaluates the safety and preliminary efficacy of adding investigational MT-II to standardized NB-UVB phototherapy compared with placebo plus NB-UVB in adults with stable nonsegmental vitiligo. Participants are randomized 1:1 and treated for 24 weeks, with standardized digital photography, clinician-rated scoring, and objective colorimetry performed at prespecified visits. Safety monitoring includes adverse event collection, vital signs, and focused skin examinations (including monitoring of nevi). A follow-up visit occurs 4 weeks after the final dose to assess ongoing safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18-65 years able to provide informed consent.\n* Clinical diagnosis of nonsegmental vitiligo with stable disease (no new lesions and no lesion expansion) for \\>=6 months prior to screening.\n* Total body surface area involvement between 3% and 20% (inclusive), with at least two measurable target lesions suitable for standardized photography and colorimetry.\n* Willingness to undergo NB-UVB phototherapy per protocol and to avoid non-study vitiligo treatments during the study.\n* For participants of childbearing potential: agreement to use effective contraception during the study and for a protocol-specified period after the last dose.\n\nExclusion Criteria:\n\n* Segmental vitiligo as the predominant type, or rapidly progressive disease within the past 6 months.\n* Use of systemic immunosuppressive therapy, systemic corticosteroids, or JAK inhibitors within 8 weeks prior to screening (time windows may vary by drug/class).\n* Use of topical calcineurin inhibitors or topical corticosteroids on target lesions within 2 weeks prior to baseline.\n* Prior treatment with afamelanotide or melanotan (including Melanotan II) within 6 months prior to baseline.\n* History of melanoma, dysplastic nevus syndrome, or other high-risk skin cancer history requiring close surveillance, as judged by the investigator.\n* Clinically significant uncontrolled hypertension, cardiovascular disease, or any condition that, in the investigator's judgment, increases risk with melanocortin agonist exposure.\n* Pregnant or breastfeeding.\n* Known hypersensitivity to study product components.\n* Participation in another interventional clinical trial within 30 days prior to screening."}, 'identificationModule': {'nctId': 'NCT07437560', 'acronym': 'MTII-VIT', 'briefTitle': 'Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hudson Biotech'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Melanotan II (Synthetic Cyclic Melanocortin Receptor Agonist) as an Adjunct to Narrowband UV-B Phototherapy in Adults With Stable Nonsegmental Vitiligo', 'orgStudyIdInfo': {'id': 'DERM-MTII-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melanotan II + NB-UVB phototherapy', 'interventionNames': ['Drug: Melanotan II (MT-II)', 'Drug: Placebo', 'Procedure: Narrowband UV-B (NB-UVB) phototherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + NB-UVB phototherapy', 'interventionNames': ['Drug: Melanotan II (MT-II)', 'Drug: Placebo', 'Procedure: Narrowband UV-B (NB-UVB) phototherapy']}], 'interventions': [{'name': 'Melanotan II (MT-II)', 'type': 'DRUG', 'description': 'administered per protocol', 'armGroupLabels': ['Melanotan II + NB-UVB phototherapy', 'Placebo + NB-UVB phototherapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matched, administered per protocol.', 'armGroupLabels': ['Melanotan II + NB-UVB phototherapy', 'Placebo + NB-UVB phototherapy']}, {'name': 'Narrowband UV-B (NB-UVB) phototherapy', 'type': 'PROCEDURE', 'description': 'standardized schedule per site protocol', 'armGroupLabels': ['Melanotan II + NB-UVB phototherapy', 'Placebo + NB-UVB phototherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518036', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhen J Peng, Phd', 'role': 'CONTACT', 'email': 'Zhen-Peng@beijing-biotech.com', 'phone': '+86 13076790039'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Seni S Lu, Phd', 'role': 'CONTACT', 'email': 'Seni-Lu@beijing-biotech.com', 'phone': '+86 13076790030'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hudson Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}