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A Phase II, Open Label Pilot Study to Evaluate the Safety and Efficacy of A Bioresorbable Subcutaneous Implant of CUV1647 in Patients with Solar Urticaria (SU) - Phase II SU Pilot Study

A Phase II, Open Label Pilot Study to Evaluate the Safety and Efficacy of A Bioresorbable Subcutaneous Implant of CUV1647 in Patients with Solar Urticaria (SU) - Phase II SU Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001068-55-GB
Enrollment
Unknown
Registered
2008-02-13
Start date
2007-11-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solar Urticaria (SU) MedDRA version: 9.1 Level: LLT Classification code 10041307 Term: Solar urticaria

Interventions

Product Name: CUV1647 Product Code: CUV1647 Pharmaceutical Form: Implant

Sponsors

Clinuvel Pharmaceuticals Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Male or female subjects with a diagnosis of solar urticaria (confirmed by phototesting) of sufficient severity that they have requested treatment to alleviate symptoms. -React to provocation with a light source 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

Exclusion criteria: -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 ß-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). -Any factors that may affect skin reflectance measurements.

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine whether a CUV1647 implant can reduce the susceptibility of patients with Solar Urticaria to provocation with a standardized light source (measured as a change in minimum urticarial dose, (MUD)).;Secondary Objective: - To evaluate the safety/tolerability of CUV1647 by measuring treatment-emergent adverse events. - To determine the effect of CUV1647 on melanin density at several specified body sites. - To evaluate a change in the MUD between Days 30 and 60. ;Primary end point(s): The primary efficacy endpoint of this study is the minimum urticarial dose. The primary efficacy analysis will compare the minimum urticarial dose at baseline and after CUV1647 treatment at Day 30 in each patient.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026