Clinical trial NCT05210582: A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
Official title: An Open Label, Phase II Study to Assess the Changes in Pigmentation and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants in the Treatment of Vitiligo on the Face
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vitiligo
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2022-01-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.


Eligibility criteria: Inclusion Criteria:

* Male and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.5-50%
* Stable face vitiligo with F-VASI of at least 0.1%
* Stable or slowly progressive vitiligo over a 3-month period
* Fitzpatrick skin types IV-VI
* Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming

Exclusion Criteria:

* Patients with segmental vitiligo
* Fitzpatrick skin types I-III
* Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, excluding the sessions for priming in the four weeks prior to treatment. A 3-month washout period from phototherapy is necessary prior to priming.
* Previous topical treatment for vitiligo
* 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
* History of melanoma or lentigo maligna
* Any current skin disease that may interfere with the study evaluation
* Presence of severe hepatic disease or hepatic impairment
* Renal impairment
* History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation
* Female who is pregnant or lactating
* Female of child-bearing potential not using adequate contraceptive measures during the treatment phase and for a period of three months thereafter
* Sexually active man with a partner of child-bearing potential 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 other prior and concomitant therapy which may interfere with the objective of the study
* Subjects assessed as not suitable for the study in the opinion of the Investigator

Primary outcomes:
measure: Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
timeFrame: From Baseline to Day 84
Secondary outcomes:
measure: Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area
timeFrame: From Baseline to Day 84
measure: Percentage change in pigmentation on body surface area measured by the VASI scoring system
timeFrame: From Baseline to Day 84
measure: Percentage change in pigmentation on facial surface area measured by the VASI scoring system
timeFrame: From Baseline to Day 168
measure: Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)
timeFrame: From Baseline to Day 168
measure: Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)
timeFrame: From Baseline to Day 168
measure: Change in Quality of life using a vitiligo specific tool (C)
timeFrame: From Baseline to Day 168
Other outcomes:
Locations:
city: Detroit
country: United States
facility: CLINUVEL Investigational site
state: Michigan
Study officials:
References: