A Phase III, randomised, double blind, placebo controlled, parallel group study, to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from polymorphic light eruption (PLE). - Phase III Trial of 16 mg Afamelanotide in PLE

• Register: EUCTR
• Last refreshed on: 14 October 2013
• Main ID: EUCTR2009-017359-92-BE
• Date of registration: 11/02/2010
• Prospective Registration: Yes
• Primary sponsor: Clinuvel Pharmaceuticals Limited
• Public title: A Phase III, randomised, double blind, placebo controlled, parallel group study, to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from polymorphic light eruption (PLE). - Phase III Trial of 16 mg Afamelanotide in PLE
• Scientific title: A Phase III, randomised, double blind, placebo controlled, parallel group study, to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from polymorphic light eruption (PLE). - Phase III Trial of 16 mg Afamelanotide in PLE
• Date of first enrolment: 29/03/2010
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017359-92
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Germany, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
To be eligible to enter the study, subjects must meet the following inclusion criteria:
- Aged greater than 18 years;
- Male or female patients with a documented history of PLE diagnosed or confirmed by a photodermatologist or photobiologist, with a history of PLE related pruritus symptoms;
- Recurrent PLE episodes that occur at least once a year (as evidenced by PLE related pruritus symptoms) developing in their own country (to exclude patients affected only when traveling to sunnier climates);
- Written informed consent prior to the performance of any study-specific procedure; and
- Are willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
To be eligible to enter the study, subjects must not meet any of the following exclusion criteria:
- Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi;
- Current Bowen’s Disease, basal cell carcinoma, squamous cell carcinoma or other malignant skin lesions;
- Patients currently requiring treatment with systemic immunosuppressive agents;
- Documented history of other photosensitive conditions which may be confused with PLE or interfere with the assessment of PLE episodes;
- Solarium use in the three months prior to study involvement and throughout the duration of the study;
- Use of immunosuppressive medications, drugs that cause hyperpigmentation or any other treatment that in the opinion of the investigator may interfere with this study;
- Documented presence (> 1 in 320) of Anti Nuclear Antibody (ANA) and/or positive Extractable Nuclear Antibody (ENA); historical results from the 3 years prior to randomisation are acceptable if available;
- In the opinion of the investigator, any evidence of clinically significant organ dysfunction, or any clinically significant deviation from normal in clinical or laboratory parameters;
- History of drug or alcohol abuse (in the last 1 year);
- Female who is pregnant (confirmed by positive serum ß-HCG pregnancy test prior to baseline) or lactating;
- Females of child-bearing potential (pre-menopausal, not surgically sterile) that are not using or are not willing to use adequate contraceptive measures (e.g. oral contraceptives, condoms, diaphragm plus spermicide, intrauterine device);
- Sexually active men with partners of child bearing potential not willing to use barrier contraception during the trial and for a period of three months hereafter;
- Participation in a clinical trial with another IMP within 30 days prior to the screening visit or during the study;
- Hypersensitivity to afamelanotide or any of its components;
- Hyperpigmentary disorders; and
- Use of therapeutic doses of ß-carotene and other excluded medicines, as described in the study protocol (in the last 3 months).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Polymorphic light eruption (PLE)
MedDRA version: 12.1 Level: LLT Classification code 10036087 Term: Polymorphic light eruption

Intervention(s)

Product Name: afamelanotide
Product Code: CUV1647
Pharmaceutical Form: Implant
INN or Proposed INN: Afamelanotide
CAS Number: 75921-69-6
Current Sponsor code: CUV1647
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 16-
Pharmaceutical form of the placebo: Implant
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: Secondary objectives
- To determine if afamelanotide can reduce the frequency of PLE episodes;
- To determine if afamelanotide can reduce the duration of PLE episodes;
- To evaluate the effect of afamelanotide on the use of rescue medication for the treatment of PLE episodes;
- To evaluate the effect of afamelanotide on the quality of life of PLE patients; and
- To evaluate the safety and tolerability of afamelanotide by measuring treatment-emergent adverse events.

Main Objective: Primary objectives
- To determine if afamelanotide can reduce the severity of PLE related pruritis.

Primary end point(s): Primary Endpoints will be assessed by:
- Severity of PLE related pruritus using an 11 point Likert scale, as recorded in the patient’s paper diary.

Secondary Endpoints will be assessed by:
- Frequency (number) of documented episodes of PLE, as recorded in the patient’s paper diary;
- Duration of PLE episodes;
- Quantity of rescue medication used;
- Quality of life using the Dermatology Life Quality Index (DLQI); and
- The treatment-emergent adverse events (TEAEs), including clinically significant changes in laboratory parameters following treatment.

Secondary ID(s)

CUV032

2009-017359-92-DE