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Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2007-000636-13-GB
Date of registration:	29/02/2008
Prospective Registration:	Yes
Primary sponsor:	Clinuvel Pharmaceuticals Limited
Public title:	A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study
Scientific title:	A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study
Date of first enrolment:	17/06/2008
Target sample size:	80
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000636-13
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
France	Germany	Italy	Netherlands	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
-Male or female subjects with a positive diagnosis of EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes)
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:
-Allergy to CUV1647 or the polymer contained in the implant or to lignocaine or other local anaesthetic to be used during the administration of the study medication
-Any other photodermatosis such as PLE, DLE or solar urticaria.
-Female who is pregnant, lactating or of childbearing potential and not using adequate form(s) of contraception.
-Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations.
-Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
-Personal history of melanoma or dysplastic nevus syndrome.

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

Health Condition(s) or Problem(s) studied

Erythropoietic Protoporphyria (EPP)
MedDRA version: 9.1 Level: LLT Classification code 10015289 Term: Erythropoietic protoporphyria

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: -determine whether CUV1647 can reduce the number of phototoxic reactions in patients with EPP
-determine whether CUV1647 can reduce the severity of phototoxic reactions in patients with EPP

Secondary Objective: -determine whether CUV1647 can increase the duration of sunlight tolerated by EPP patients
-determine whether CUV1647 increases melanin density in the skin at several specified body sites
-evaluate the safety and tolerability of CUV1647 by measuring treatment-emergent adverse events (AEs)
-determine whether CUV1647 can improve the quality of life of EPP patients
-in a subset of patients, determine whether CUV1647 implants can reduce the susceptibility to provocation with a standardized light source (time to appearance of provoked symptoms)

Primary end point(s): -The mean number of phototoxic reactions that occur whilst patients are on active compared with placebo implants. That is, the mean number of phototoxic reaction in (active) Group A between Days 0-60, 120-180, 240-300 plus Group B between Days 60-120, 180-240, 300-360 compared with (placebo) Group A between Days 60-120, 180-240, 300-360 plus Group B between Days 0-60, 120-180, 240-300

-The mean severity score for phototoxic reactions that occur whilst patients are on active compared with placebo implants. That is, the mean severity score in (active) Group A between Days 0-60, 120-180, 240-300 plus Group B between Days 60-120, 180-240, 300-360 compared with (placebo) Group A between Days 60-120, 180-240, 300-360 plus Group B between Days 0-60, 120-180, 240-300

Null Hypothesis: there is no difference between the mean number and severity of phototoxic reactions that occurred in patients treated with active and placebo.

Secondary Outcome(s)

Secondary ID(s)

N/A

CUV017

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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