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

NCT04425746 | Completed Phase 2 Results

• 1 other identifier: CUV025
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Patients Undergoing Photodynamic Therapy Using Porfimer Sodium

Outcome Measures

Primary Outcomes (1)

• The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting

  From Day 04 to Day 90

Secondary Outcomes (1)

• Change in Quality of Life

  From Day 0 to Day 20, Day 60 and Day 90

Study Arms (2)

Afamelanotide

EXPERIMENTAL

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.

Drug: Afamelanotide

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Afamelanotide DRUG

Afamelanotide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

MeSH Terms

Interventions

afamelanotide

Results Point of Contact

• Title: Clinical Operations Manager
• Organization: CLINUVEL PHARMACEUTICALS LTD

mail@clinuvel.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: August 5, 2008
• Primary Completion: May 28, 2009
• Study Completion: May 28, 2009
• Last Updated: October 1, 2021
• Results First Posted: October 1, 2021

Record last verified: 2021-09