AFAMELANOTIDE for Vitiligo

Inclusion criteria

• {"criterion_text":"- Male and female participants with a confirmed diagnosis of generalized vitiligo in the face and body\n- Stable or active vitiligo diagnosed for at least three months\n- Fitzpatrick skin types III-VI\n- Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator\n- Providing written Informed Consent prior to the performance of any study-specific procedure"}

Exclusion criteria

• {"criterion_text":"- Fitzpatrick skin types I-II\n- Any other treatment for vitiligo within 30 days prior to the Screening Visit\n- History of melanoma or lentigo maligna\n- History of dysplastic nevus syndrome\n- Any malignant skin lesions\n- Any skin disease that may interfere with the study evaluation\n- Presence of severe hepatic disease or hepatic impairment\n- Female who is pregnant or lactating\n- Female of child-bearing potential not using effective contraceptive methods\n- Sexually active man with a partner of child-bearing potential who is not using effective contraceptive methods\n- Use of any prior and concomitant therapy which may interfere with the objective of the study\n- Extensive leukotrichia\n- Treatment with NB-UVB phototherapy in the last three months prior to phototherapy\n- Allergy to afamelanotide or the polymer contained in the implant"}

Primary endpoints

• {"endpoint_text":"- Percentage of participants achieving re pigmentation in those treated with SCENESSE® and NB-UVB compared to NB-UVB alone.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Time to onset of repigmentation","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to onset of repigmentation of face","definition_or_measurement_approach":""}

Methods

• Posters (multiple versions: IT, FR, EN) - target audience: patients with vitiligo; country-specific versions for Italy and France
• eFlyers / Flyers (IT, FR, EN) - online and in-clinic distribution targeting people with vitiligo
• Webpage content (site-specific content, IT and FR versions) - online recruitment targeting patients and caregivers
• Social media / Internet adverts (digital banners, social media content) - online targeting people with vitiligo in relevant countries (Italy, France)
• Video advertisement (IT and EN) - online/TV targeting potential participants
• Radio advertisement scripts (IT and EN) - broadcast targeting general public in Italy
• Patient brochure and participation card (IT, FR, EN) - clinic-based recruitment materials
• GP Letter (Italy) - engagement of primary care physicians to refer patients

Italy

Earliest CTIS Part Ii Submission Date

02-04-2024

Latest Decision Or Authorization Date

23-04-2025

Processing Time Days

386

Number Of Sites

1

Number Of Participants

10

France

Earliest CTIS Part Ii Submission Date

02-04-2024

Latest Decision Or Authorization Date

21-01-2026

Processing Time Days

659

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Clinuvel Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States