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Status unknownNCT00829192Updated Dec 6, 2010

Phase II AK Study in Organ Transplant Patients

A Phase 2 interventional study of Afamelanotide (CUV1647) and Placebo in Actinic Keratoses, Carcinoma, Squamous Cell and Organ Transplant Recipients, sponsored by Clinuvel Pharmaceuticals Limited. Status unknown at 12 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-12-06.

Sponsored by Clinuvel Pharmaceuticals Limited · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Actinic Keratoses
  • Carcinoma, Squamous Cell
  • Organ Transplant Recipients

Keywords

  • Actinic keratoses (AK)
  • Squamous cell carcinomas (SCC)
  • CUV1647
  • Afamelanotide
  • Clinuvel
  • Photoprotection
  • Organ transplant
03

In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Clinuvel Pharmaceuticals Limited is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    1

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

    Drug: Afamelanotide (CUV1647)

  • Placebo comparator
    2

    Placebo implant administered subcutaneously every 60 days for 24 months

    Drug: Placebo

Interventions

  • DrugAfamelanotide (CUV1647)

    16 mg subcutaneous implant administered every 60 days

  • DrugPlacebo

    Placebo subcutaneous implant administered every 60 days

06

What researchers measure

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

    Time frame: 24 months

Secondary outcomes

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

07

Study locations

12 sites
  • The Princess Alexandra Hospital
    Brisbane, Queensland 4102, Australia
  • The Queen Elizabeth Hospital
    Adelaide, South Australia 5011, Australia
  • The Royal Melbourne Hospital
    Melbourne, Victoria, Australia
  • Hospital Erasme
    Brussels, Belgium
  • Gent University Hospital
    Gent, Belgium
  • University Hospital
    Besancon, France
  • Charité Univeritätsklinikum
    Berlin, Germany
  • Kiel University Hospital
    Kiel, Germany
  • Ospedali Riuniti di Bergamo
    Bergamo, Italy
  • University of Padua
    Padua, Italy
  • Karolinska University Hospital
    Stockholm, Sweden
  • Universitätsspital Zürich
    Zürich, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00829192
Lead sponsor
Clinuvel Pharmaceuticals Limited
First posted
Jan 26, 2009
Start date
Nov 2007
Primary completion
Jul 2012 (estimated)
Completion
Aug 2012 (estimated)
Last update
Dec 6, 2010

Study contacts

Günther Hofbauer, M.D.
principal investigator · Universitätsspital Zürich

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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