A Phase III, randomised, double blind, placebo controlled study to evaluate the safety and efficacy of subcutaneous implants of CUV1647 in patients suffering from polymorphic light eruption (PLE) - Phase III Trial of CUV1647 in PLE

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-005321-40-AT
• Date of registration: 06/02/2007
• Prospective Registration: No
• Primary sponsor: Clinuvel Pharmaceuticals Limited
• Public title: A Phase III, randomised, double blind, placebo controlled study to evaluate the safety and efficacy of subcutaneous implants of CUV1647 in patients suffering from polymorphic light eruption (PLE) - Phase III Trial of CUV1647 in PLE
• Scientific title: A Phase III, randomised, double blind, placebo controlled study to evaluate the safety and efficacy of subcutaneous implants of CUV1647 in patients suffering from polymorphic light eruption (PLE) - Phase III Trial of CUV1647 in PLE
• Date of first enrolment: 01/02/2007
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005321-40
• 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

Austria, Finland, France, Germany, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
•Documented history of moderate/severe PLE as diagnosed/confirmed by a photodermatologist/photobiologist
•Patients have recurrent episodes that occur at least once per year in their local environment

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:
•PLE requiring treatment with systemic immunosuppressive agents
•Documented history of other photosensitivity conditions eg. Solar urticaria
•Documented presence of anti nuclear antibody and/or positive extractable nuclear antibody
•Evidence of clinically significant organ dysfunction or clinically significant deviation from normal in clinical or laboratory parameters
•Females who are pregnant, lactating or of childbearing potential and not using adequate form(s) of contraception
•Personal history of melanoma, lentigo maligma or multiple dysplastic nevi.



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

Health Condition(s) or Problem(s) studied

polymorphic light eruption (PLE)
MedDRA version: 9.1 Level: PT Classification code 10036087 Term: Polymorphic light eruption

Intervention(s)

Product Name: CUV1647
Product Code: CUV1647
Pharmaceutical Form: Implant
Pharmaceutical form of the placebo: Implant
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: •Evaluate whether CUV1647 prevents episodes or reduces the severity of symptoms in patients with PLE
•Evaluate the safety and tolerability of CUV1647
•Evaluate the effect of CUV1647 on the use of rescue medication for the treatment of PLE symptoms
•Evaluate the effect of CUV1647 on melanin density measured by skin reflectance

Primary end point(s): •Physician’s global severity assessment and patient’s assessment at Days 60, 120 and 150.
•Cumulative disease burden at Days 60, 120 and 150 in years 1 and 2.
•Amount of rescue medication used
•Changes in melanin density from baseline

Secondary Objective: •Determine whether CUV1647 has a beneficial effect on the quality of life of PLE sufferers
•Determine if there are any confounding factors that may influence the severity of PLE symptoms

Secondary ID(s)

N/A

2006-005321-40-GB

CUV015