Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

Clinuvel

Status and phase: Completed; Phase 2

Conditions: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium

Treatments: Drug: Afamelanotide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04425746

CUV025

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
• Aged greater than 18 years;
• Written informed consent prior to the performance of any study-specific procedure.

Exclusion criteria

• Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
• Non-Caucasian patients;
• Personal history of melanoma or dysplastic nevus syndrome;
• Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
• Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating;
• Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
• Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit;
• Patients unable to give informed consent;
• Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Afamelanotide

Experimental group

Description:

Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.

Treatment:

Drug: Afamelanotide

Placebo

Placebo Comparator group

Description:

Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.

Treatment:

Drug: Placebo