Phase II AK Study in Organ Transplant Patients

NCT00829192 | Unknown Phase 2 DMC

• 1 other identifier: CUV011
• Study Type: interventional
• Target: 200
• Locations: 7 countries
• Sites: 12

Brief Summary

The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period. The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.

Conditions

Actinic Keratoses; Carcinoma, Squamous Cell; Organ Transplant Recipients

Keywords

Actinic keratoses (AK); Squamous cell carcinomas (SCC); CUV1647; Afamelanotide; Clinuvel; Photoprotection; Organ transplant

Outcome Measures

Primary Outcomes (1)

• To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands

  24 months

Secondary Outcomes (3)

• To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)

  24 months

• To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group

  24 months

• To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)

  24 months

Study Arms (2)

1

EXPERIMENTAL

Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months

Drug: Afamelanotide (CUV1647)

2

PLACEBO COMPARATOR

Placebo implant administered subcutaneously every 60 days for 24 months

Drug: Placebo

Interventions

Afamelanotide (CUV1647) DRUG

16 mg subcutaneous implant administered every 60 days

1

Placebo DRUG

Placebo subcutaneous implant administered every 60 days

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry
• Organ transplant patients who have had at least one biopsy-positive SCC
• Aged 18 - 75 years
• Written informed consent to the performance of all study-specific procedures

You may not qualify if:

• Allergy to afamelanotide (CUV1647) or the polymer contained in the implant
• History of melanoma
• Current pigmentary disorders such as melasma
• Diagnosed with HIV/AIDS, or hepatitis B or C
• Current history of drug or alcohol abuse (in the last 12 months)
• Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures
• Major medical or psychiatric illness
• Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers
• Females of child bearing potential not using adequate contraceptive measures
• Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit
• Use of regular medications or any other factors that may affect skin pigmentation
• Discontinuation Criteria:
• Initiation of treatment with systemic retinoids
• Change of class of systemic immunosuppressant treatment

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

Study Sites (12)

The Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

The Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

Location

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Location

Hospital Erasme

Brussels, Belgium

Location

Gent University Hospital

Ghent, Belgium

Location

University Hospital

Besançon, France

Location

Charité Univeritätsklinikum

Berlin, Germany

Location

Kiel University Hospital

Kiel, Germany

Location

Ospedali Riuniti di Bergamo

Bergamo, Italy

Location

University of Padua

Padua, Italy

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Keratosis, Actinic; Carcinoma, Squamous Cell

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Günther Hofbauer, M.D.

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: November 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 6, 2010

Record last verified: 2010-12

Locations

AU (3); BE (2); FR (1); SE (1); DE (2); IT (2); CH (1)