Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruiting
Participants planned
200
Countries
2
Sites
3
Vitiligo
To evaluate the efficacy of SCENESSE® and NB-UVB compared to NB-UVB alone in repigmentation of vitiligo
Key facts
- Sponsor
- Clinuvel Inc.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 27 Aug 2024 → ongoing
- Decision date (initial)
- 2024-04-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- CLINUVEL Inc
External identifiers
- EU CT number
- 2023-507470-40-00
- ClinicalTrials.gov
- NCT06109649
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy of SCENESSE® and NB-UVB compared to NB-UVB alone in repigmentation of vitiligo
Secondary objectives 3
- 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
- To compare the maintenance of pigmentation achieved with SCENESSE® and NB-UVB versus NB-UVB alone in participants with vitiligo
Conditions and MedDRA coding
Vitiligo
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10047642 | Vitiligo | 100000004858 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase III Vitiligo Study 20-week Phase III study with three and six months follow-up period
|
Randomised Controlled | None | Group A: Participants will receive NB-UVB (twice weekly) and SCENESSE® (one implant administered every three weeks) for 20 weeks Group B: Participants will receive NB-UVB light only (administered twice weekly for 20 weeks) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male and female participants with a confirmed diagnosis of generalized vitiligo in the face and body
- Stable or active vitiligo diagnosed for at least three months
- Fitzpatrick skin types III-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
Exclusion criteria 14
- Fitzpatrick skin types I-II
- Presence of severe hepatic disease or hepatic impairment
- Female who is pregnant or lactating
- Female of child-bearing potential not using effective contraceptive methods
- Sexually active man with a partner of child-bearing potential who is not using effective contraceptive methods
- Use of any prior and concomitant therapy which may interfere with the objective of the study
- Extensive leukotrichia
- Treatment with NB-UVB phototherapy in the last three months prior to phototherapy
- Allergy to afamelanotide or the polymer contained in the implant
- Any other treatment for vitiligo within 30 days prior to the Screening Visit
- History of melanoma or lentigo maligna
- History of dysplastic nevus syndrome
- Any malignant skin lesions
- Any skin disease that may interfere with the study evaluation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of participants achieving re pigmentation in those treated with SCENESSE® and NB-UVB compared to NB-UVB alone.
Secondary endpoints 2
- Time to onset of repigmentation
- Time to onset of repigmentation of face
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD7367850 · Product
- Active substance
- Afamelanotide
- Pharmaceutical form
- IMPLANT
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 5 Month(s)
- Authorisation status
- Authorised
- ATC code
- D02BB02 — -
- Marketing authorisation
- EU/1/14/969/001
- MA holder
- CLINUVEL EUROPE LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/1/14/969/001
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Clinuvel Inc.
- Sponsor organisation
- Clinuvel Inc.
- Address
- 1350 Old Bayshore Hwy, Ste 520 Ste 520
- City
- Burlingame
- Postcode
- 94010-1814
- Country
- United States
Scientific contact point
- Organisation
- Clinuvel Inc.
- Contact name
- Head of Clinical Operations
Public contact point
- Organisation
- Clinuvel Inc.
- Contact name
- Head of Clinical Operations
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 30 | 2 |
| Italy | Ended | 10 | 1 |
| Rest of world
United States, United Kingdom, Mexico, Kenya
|
— | 160 | — |
Investigational sites
Centre Hospitalier Universitaire De La Reunion
Dermatology, Allee Des Topazes, Cs 11021, Saint-Denis
Centre Hospitalier Universitaire De Nice
Dermatology, 151 Route De Saint Antoine, 06200, Nice
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-08-27 | 2024-08-27 | 2025-05-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 91 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507470-40-00 EU_FP | 4.2 |
| Protocol (for publication) | D1_Study Protocol 2023-507470-40-00 Signature Page_for public | 2.1 |
| Protocol (for publication) | D1_Study Protocol 2023-507470-40-00_for public | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements IT_FP | 2.1 |
| Recruitment arrangements (for publication) | K1_Template Recruitment and ICF procedure France FR_for public | 2.2 |
| Recruitment arrangements (for publication) | K1. Template Recruitment and ICF procedure IT_for public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Advertisement IT in English_V2.0_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruiting material Advertisement IT in English_V3.1_FP | 3.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Advertisement IT_V3.1_FP | 3.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Digital Banners IT in English_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Digital Banners IT_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material eFlyer FR_V2.1_FP | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material eFlyer IT in English_V1.0_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruiting material eFlyer IT in English_V2.1_FP | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material eFlyer IT_V2.1_FP | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Flyer FR_FP | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruiting material Flyer IT in English_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Flyer IT_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Internet Adverts IT in English_V1.1_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Internet Adverts IT_V1.2_FP | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruiting material Patient Brochure FR_FP | 2.2 |
| Recruitment arrangements (for publication) | K2_Recruiting material Patient Brochure IT in English_FP | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Patient Brochure IT_FP | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Poster FR_FP | 2.2 |
| Recruitment arrangements (for publication) | K2_Recruiting material Poster IT in English_V1.2_FP | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruiting material Poster IT in English_V2.1_FP | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Poster IT_V2.1_FP | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Radio Advertisement Script IT in English_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Radio Advertisement Script IT_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Video Advertisement IT in English_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Video Advertisement IT_FP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruiting material Webpage content IT in English_V7.0_FP | 7.0 |
| Recruitment arrangements (for publication) | K2_Recruiting material Webpage content IT_V5.0_FP | 5.0 |
| Recruitment arrangements (for publication) | K2_Recruiting material Webpage content IT_V7.0_FP | 7.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Poster IT TC_for public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Poster IT_for public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster IT_for public | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Social media Internet adverts content IT TC_for public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Social media Internet adverts content IT_for public | 1.1 |
| Recruitment arrangements (for publication) | K2. Recruitment material Advertisement IT_for public | 2.0 |
| Recruitment arrangements (for publication) | K2. Recruitment material eFlyer IT_for public | 1.0 |
| Recruitment arrangements (for publication) | K2. Recruitment Material Poster IT_for public | 1.1 |
| Recruitment arrangements (for publication) | K2. Recruitment Material Social media Internet adverts content IT_for public | 1.1 |
| Recruitment arrangements (for publication) | K2. Recruitment Material Webpage content_for public | 5.0 |
| Subject information and informed consent form (for publication) | B1_Cover letter nSA01_for public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult and Parent IT_For public | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult FR_FP | 3.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult IT TC_for public | 2.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult IT_for public | 2.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult IT_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Paediatric Assent FR_FP | 3.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Paediatric Assent IT TC_for public | 2.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Paediatric Assent IT_for public | 2.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Paediatric Assent IT_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parent FR_FP | 3.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parent IT TC_for public | 2.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parent IT_for public | 2.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parent IT_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Monitoring for Follow up of child FR_for public | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Monitoring for Pregnant Participant FR_for public | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Monitoring for Pregnant Partner FR_for public | 1.6 |
| Subject information and informed consent form (for publication) | L1. SIS and ICF Adult IT_for public | 2.3 |
| Subject information and informed consent form (for publication) | L1. SIS and ICF For Pregnancy Monitoring for Partner IT_for public | 1.2 |
| Subject information and informed consent form (for publication) | L1. SIS and ICF Paediatric Assent IT_for public | 2.2 |
| Subject information and informed consent form (for publication) | L1. SIS and ICF Parent IT_for public | 2.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material GP letter IT_FP | 2.1 |
| Subject information and informed consent form (for publication) | L2. Other subject information material Afamelanotide educational video script FR_for public | 1.0 |
| Subject information and informed consent form (for publication) | L2. Other subject information material Afamelanotide educational video script IT_for public | 1.1 |
| Subject information and informed consent form (for publication) | L2. Other subject information material GP Letter IT_for public | 1.1 |
| Subject information and informed consent form (for publication) | L2. Other subject information material Participation card FR_for public | 1.2 |
| Subject information and informed consent form (for publication) | L2. Other subject information material Participation card IT_for public | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC afamelanotide 16mg_EN CLEAN_FP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2. SmPC afamelanotide16mg FR_for public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1. SmPC afamelanotide16mg IT_For public | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis FR_for public | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2023-507470-40-00_FP | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-507470-40-00_FP | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2023-507470-40-00_FP | 4.2 |
| Synopsis of the protocol (for publication) | D1. Protocol Synopsis IT _for public | 2.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaire D FR_for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaire E FR _for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaire E IT _for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires A FR_for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires A IT_for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires B FR | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires B IT_for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires C FR_for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires C IT _for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires D IT _for public | 1.0 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires F FR_for public | 1 |
| Synopsis of the protocol (for publication) | D4. Patient facing documents Questionnaires F IT_for public | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-06 | France | Acceptable 2024-04-15
|
2024-04-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-23 | France | Acceptable 2024-04-15
|
2024-04-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-31 | France | Acceptable 2024-04-15
|
2024-07-31 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-06 | Acceptable 2024-04-15
|
2025-01-06 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-23 | France | Acceptable 2025-04-18
|
2025-04-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-24 | France | Acceptable 2026-01-20
|
2026-01-21 |