Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 8:33 PM
Study NCT ID:
NCT04525157
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
Sponsor:
Organization:
Raw JSON
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A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Urinary casts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nail pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Afamelanotide and NB-UVB (Pooled Analysis)', 'description': 'The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.'}], 'classes': [{'title': 'Total Day 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.63', 'upperLimit': '0.25'}]}]}, {'title': 'Head and Neck Day 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.63', 'upperLimit': '0.00'}]}]}, {'title': 'Hands Day 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Upper Extremities Day 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.25'}]}]}, {'title': 'Trunk Day 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Lower Extremities Day 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Feet Day 28', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Total Day 56', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '1.00'}]}]}, {'title': 'Head and Neck Day 56', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.88', 'upperLimit': '1.00'}]}]}, {'title': 'Hands Day 56', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.00'}]}]}, {'title': 'Upper Extremities Day 56', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-1.50', 'upperLimit': '0.25'}]}]}, {'title': 'Trunk Day 56', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}]}]}, {'title': 'Lower Extremities Day 56', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '0.00'}]}]}, {'title': 'Feet Day 56', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.00'}]}]}, {'title': 'Total Day 84', 'categories': [{'measurements': [{'value': '-0.70', 'groupId': 'OG000', 'lowerLimit': '-12.38', 'upperLimit': '0.25'}]}]}, {'title': 'Head and neck Day 84', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.88', 'upperLimit': '1.00'}]}]}, {'title': 'Hands Day 84', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.00'}]}]}, {'title': 'Upper Extremities Day 84', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-1.50', 'upperLimit': '0.25'}]}]}, {'title': 'Trunk Day 84', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-7.75', 'upperLimit': '0.00'}]}]}, {'title': 'Lower Extremities Day 84', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-4.50', 'upperLimit': '0.00'}]}]}, {'title': 'Feet Day 84', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.00'}]}]}, {'title': 'Total Day 112', 'categories': [{'measurements': [{'value': '-1.13', 'groupId': 'OG000', 'lowerLimit': '-12.38', 'upperLimit': '0.00'}]}]}, {'title': 'Head and Neck Day 112', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '0.50'}]}]}, {'title': 'Hands Day 112', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.00'}]}]}, {'title': 'Upper Extremities Day 112', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '0.25'}]}]}, {'title': 'Trunk Day 112', 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-7.75', 'upperLimit': '0.00'}]}]}, {'title': 'Lower Extremities Day 112', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-4.50', 'upperLimit': '0.38'}]}]}, {'title': 'Feet Day 112', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.00'}]}]}, {'title': 'Total Day 140', 'categories': [{'measurements': [{'value': '-2.56', 'groupId': 'OG000', 'lowerLimit': '-15.15', 'upperLimit': '0.00'}]}]}, {'title': 'Head and Neck Day 140', 'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}]}]}, {'title': 'Hands Day 140', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}]}]}, {'title': 'Upper Extremities Day 140', 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000', 'lowerLimit': '-6.00', 'upperLimit': '0.13'}]}]}, {'title': 'Trunk Day 140', 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000', 'lowerLimit': '-7.75', 'upperLimit': '0.00'}]}]}, {'title': 'Lower Extremities Day 140', 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000', 'lowerLimit': '-5.85', 'upperLimit': '0.38'}]}]}, {'title': 'Feet Day 140', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.00'}]}]}, {'title': 'Total Day 168', 'categories': [{'measurements': [{'value': '-2.86', 'groupId': 'OG000', 'lowerLimit': '-15.15', 'upperLimit': '0.00'}]}]}, {'title': 'Head and Neck Day 168', 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}]}]}, {'title': 'Hands Day 168', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}]}]}, {'title': 'Upper Extremities Day 168', 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000', 'lowerLimit': '-6.00', 'upperLimit': '1.00'}]}]}, {'title': 'Trunk Day 168', 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-7.75', 'upperLimit': '0.00'}]}]}, {'title': 'Lower Extremities Day 168', 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000', 'lowerLimit': '-5.85', 'upperLimit': '0.38'}]}]}, {'title': 'Feet Day 168', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.00'}]}]}, {'title': 'Total Day 196', 'categories': [{'measurements': [{'value': '-3.70', 'groupId': 'OG000', 'lowerLimit': '-15.65', 'upperLimit': '1.00'}]}]}, {'title': 'Head and Neck Day 196', 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}]}]}, {'title': 'Hands Day 196', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}]}]}, {'title': 'Upper Extremities Day 196', 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-6.00', 'upperLimit': '1.00'}]}]}, {'title': 'Trunk Day 196', 'categories': [{'measurements': [{'value': '-1.13', 'groupId': 'OG000', 'lowerLimit': '-7.75', 'upperLimit': '0.75'}]}]}, {'title': 'Lower Extremities Day 196', 'categories': [{'measurements': [{'value': '-0.60', 'groupId': 'OG000', 'lowerLimit': '-5.85', 'upperLimit': '0.38'}]}]}, {'title': 'Feet Day 196', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 0 to Day 196', 'description': "A decrease in VASI over time indicates a reduction of the body surface area affected by vitiligo and/ or a reduction in the body sites' degree of depigmentation (possible range 1-100)", 'unitOfMeasure': 'Change in VASI score from baseline', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Afamelanotide and NB-UVB (Pooled Analysis)', 'description': 'The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '18 participants were enrolled in the Arm Afamelanotide and NB-UVB (pooled analysis)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Afamelanotide and NB-UVB (Pooled Analysis)', 'description': 'The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'In the first half of the study, the Participant and Investigator are masked. In the second half of the study, the study is single arm, Open Label Study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A Two-Arm, Randomized, Double-Blind Study and a Single-Arm, Open Label, Phase IIb Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants plus Narrow-Band Ultraviolet B (NBUVB) Light Source in the Treatment of Nonsegmental Vitiligo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2016-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2020-08-06', 'resultsFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-29', 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)', 'timeFrame': 'From Day 0 to Day 196', 'description': "A decrease in VASI over time indicates a reduction of the body surface area affected by vitiligo and/ or a reduction in the body sites' degree of depigmentation (possible range 1-100)"}]}, 'conditionsModule': {'conditions': ['Vitiligo']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of afamelanotide, when combined with narrowband ultraviolet B (NB-UVB) phototherapy, in patients with nonsegmental vitiligo. Afamelanotide is expected to increase the rate of the repigmentation induced by NB-UVB, leading to a reduced frequency and dose of NB-UVB.', 'detailedDescription': 'Vitiligo is the most common depigmentation disorder. A commonly used treatment is phototherapy with narrow-band ultraviolet B irradiation (NB-UVB). Further therapeutic approaches are desired and currently being evaluated. The investigational product, afamelanotide, is a synthetic analogue of the human alpha melanocyte stimulating hormone (alpha-MSH). Afamelanotide activates melanin in skin, with the controlled-release injectable implant formulation having an affect across the total body surface area (pandermally). Earlier studies in vitiligo patients showed afamelanotide, in combination with NB-UVB, could induce faster and deeper repigmentation in patients compared to NB-UVB alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* for double-blind phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement\n* for open label phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 10% to 50% of total body surface involvement\n* Vitiligo involving the head and neck\n* Stable or slowly progressive vitiligo over a 3-month period\n* Aged 21 years or more\n* Willing and able to comply with the conditions specified in this protocol and study procedures, in the opinion of the Investigator\n* Provided written Informed Consent prior to the performance of any study-specific procedure\n\nExclusion Criteria:\n\n* Extensive leukotrichia, in the opinion of the Investigator\n* Previous treatment with NB-UVB light or other light source within 6 weeks prior to the Screening Visit\n* Patient not responsive to previous NB-UVB light treatment, defined as a patient who had undergone at least 20 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator\n* Previous topical treatment for vitiligo, including topical immunomodulators (e.g. corticosteroids, calcineurin inhibitors), within 4 weeks prior to the Screening Visit\n* Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant\n* History of photosensitivity disorders\n* Claustrophobia\n* Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator\n* Any current skin disease that may have interfered with the study evaluation\n* Female who was pregnant (confirmed by positive β-human chorionic gonadotropin (HCG) pregnancy test) or lactating\n* Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives or diaphragm plus spermicide or intrauterine device) during the treatment phase (7 months) and for a period of three months thereafter - except if abstinence from intercourse was practiced\n* Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who was not using adequate contraceptive measures, as described above\n* Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit'}, 'identificationModule': {'nctId': 'NCT04525157', 'briefTitle': 'Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinuvel Pharmaceuticals Limited'}, 'officialTitle': 'A Two-Arm, Randomized, Double-Blind, Phase IIb Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source With Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo AND A Single-Arm, Open Label, Phase IIb Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo', 'orgStudyIdInfo': {'id': 'CUV103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afamelanotide and NB-UVB', 'description': 'Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).', 'interventionNames': ['Drug: Afamelanotide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and NB-UVB', 'description': 'Participants received Placebo implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single-Arm, Open Label Group', 'description': 'The study design was modified into a single-arm, open label study with only one treatment group receiving afamelanotide implants plus NB-UVB light.\n\nParticipants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).', 'interventionNames': ['Drug: Afamelanotide']}], 'interventions': [{'name': 'Afamelanotide', 'type': 'DRUG', 'armGroupLabels': ['Afamelanotide and NB-UVB', 'Single-Arm, Open Label Group']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo and NB-UVB']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinuvel Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}