Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405869934666 Date of Registration: 02/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Phase III Vitiligo Study]
Official scientific title A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE® and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo
Brief summary describing the background and objectives of the trial Vitiligo, the most common depigmentation disorder, affecting people worldwide with a prevalence of 0.1 to 2%, is an acquired disorder characterized by a chronic and progressive loss of functional epidermal and/or hair follicle melanocytes1,2. The disease usually begins in childhood or young adulthood with a peak onset at 10-30 years2,3. Both genders are equally affected, and there are no apparent differences in rates of occurrence according to skin type or race. This double-arm, open label, Phase III study is proposed to compare the efficacy and safety of the SCENESSE® implants administered every three weeks and NB-UVB in patients with vitiligo. Afamelanotide, similar to α-MSH, is unique in that it exclusively targets many cutaneous effector cells including those that play a key role in vitiligo. In addition to resident cells of the epidermis (melanocytes, keratinocytes), MC1R expressing inflammatory cells (neutrophils and lymphocytes) may also be targeted by afamelanotide. Restoring the deficient MC system in vitiligo with afamelanotide is expected to be of a therapeutic value for vitiligo. Indeed, by mimicking the effects of α-MSH, afamelanotide is expected to exert the same effects on the skin cells as the physiological hormone. In addition, afamelanotide has a stronger binding affinity to the MC1R and a slower dissociation rate than the natural occurring α-MSH. Primary Objective: To evaluate the efficacy of SCENESSE® and NB-UVB compared to NB-UVB alone in repigmentation of vitiligo on the body after 20 weeks of treatment using Total Vitiligo Area Scoring Index (T-VASI) (excluding hands and feet) Secondary Objective: To determine the safety of SCENESSE® and NB-UVB light treatment in participants with vitiligo • To evaluate the efficacy of SCENESSE® and NB-UVB compared to NB-UVB alone in repigmentation of vitiligo on the face using F-VASI (Facial VASI) (excluding scalp, ears, neck or lips) • To compare the maintenance of pigmentation achieved with SCENESSE®
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CUV 105
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 31/10/2023
Actual trial start date 01/05/2024
Anticipated date of last follow up 30/09/2025
Actual Last follow-up date 31/03/2026
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL https://clinicaltrials.gov/study/NCT06109649?cond=Vitiligo&intr=Afamelanotide&aggFilters=status:rec&rank=2
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group topical and subcutaneous NB-UVB twice weekly from Day 0 (40 treatments in total) Afamelanotide 16mg (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105 (±4) and 126 (±4) (seven implants in total)) 20 weeks of treatment Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105 (±4) and 126 (±4) (seven implants in total)) Afamelanotide 16mg implants should be administered subcutaneously using a sterile technique. 100
Control Group topical through rays twice per week 20 weeks of treatment Narrow-Band Ultraviolet B (NB-UVB) Light Alone Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total). 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Male and female participants with a confirmed diagnosis of generalized vitiligo in the face and body with T-VASI≥0.3 (excluding hands and feet) and F-VASI≥0.3 (face does not include scalp, ears, neck or lips) -Stable or active vitiligo diagnosed for at least three months -Aged 12 or more -Fitzpatrick skin types IV-VI -Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator -Providing written Informed Consent prior to the performance of any study-specific procedure -Fitzpatrick skin types I-III -Extensive leukotrichia within the vitiligo lesion (over 33%) -Treatment with NB-UVB phototherapy in the last three months prior to phototherapy. A three-month washout period from phototherapy is necessary prior to commencing treatment -Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/ lidocaine or other local anesthetic if used during the administration of the implant -Any other treatment for vitiligo within four weeks prior to the Screening Visit including JAK inhibitors -History of melanoma or lentigo malignacy -History of dysplastic nevus syndrome -Any malignant skin lesions -Any skin disease that may interfere with the study evaluation -Presence of severe hepatic disease or hepatic impairment -Female who is pregnant (confirmed by positive β-HCG pregnancy test) or lactating -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 (three months) and for a period of three months thereafter – except if abstinence from intercourse is practiced -Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who is not using adequate contraceptive measures, as described above -Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit -Use of any prior and concomitant therapy which may interfere with the objective of the study, including drugs that cause photosensitivity or skin pigmentation within 60 days prior to the Screening Visit -Participants assessed as not suitable for the study in the opinion of the Investigator 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 09/01/2024 Kenyatta National Hospital University of Nairobi Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road, Upper Hill, Nairobi Kenya Nairobi 00202 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/05/2024 KNH UoN ERC
Ethics Committee Address
Street address City Postal code Country
Hospital road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of participants achieving T-VASI50 (excluding hands and feet) on Day 140 in those treated with SCENESSE® and NB-UVB compared to NB-UVB alone. The primary efficacy endpoint will be analyzed as soon as all participant data up to and including Day 140 data become available.
Secondary Outcome Repigmentation and safety analysis day 21, day 140 to day 308
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta Nationa Hospital Hospital road, Nairobi-Kenya Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
CLINUVEL 1350 Old Bayshore Hwy, Suite 520, Burlingame, CA 94010 Burlingame United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CLINUVEL 1350 Old Bayshore Hwy, Suite 520, Burlingame, CA 94010 Burlingame United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Kenyatta National Hospital Hospital Road Nairobi 00200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Pilar Bilabo mail@clinuvel.com +441372860758 1350 Old Bayshore Hwy, Suite 520 Burlingame, CA 94010 United States
City Postal code Country Position/Affiliation
Burlingame United States of America Sponsor Representative. Head of Clinical Operarions
Role Name Email Phone Street address
Principal Investigator Hannah Wanyika drwanyika14@gmail.com +254705501600 Hospital road
City Postal code Country Position/Affiliation
Nairobi Kenya Principle Investigator Kenyatta National Hospital
Role Name Email Phone Street address
Public Enquiries Genevieve Tay mail@clinuvel.com +16505465400 1350 Old Bayshore Hwy, Suite 520 Burlingame, CA 94010
City Postal code Country Position/Affiliation
Burlingame United States of America Communications Associate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlie results in a publication are to be shared after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol Following publication, No end date Researchers who provide a methodologically sound proposal. Proposal should be directed to DPO@clinuvel.com. To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://clinicaltrials.gov/study/NCT06109649?cond=Vitiligo&intr=Afamelanotide&aggFilters=status:rec&rank=2 No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information