Actinic KeratosesPhase 2NCT00829192
Phase II AK Study in Organ Transplant Patients
A Phase 2 study testing Afamelanotide (CUV1647) in people with Actinic Keratoses and Carcinoma, Squamous Cell, run by Clinuvel Pharmaceuticals Limited at 12 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Actinic Keratoses, Carcinoma, Squamous Cell, Organ Transplant Recipients
- What is being tested?
- Afamelanotide (CUV1647)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 12 sitesin 7 countries
- Study dates
- Nov 2007to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
Australia3 sites
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
The Princess Alexandra Hospital
Brisbane, Queensland, 4102
The Royal Melbourne Hospital
Melbourne, Victoria
Germany2 sites
Charité Univeritätsklinikum
Berlin
Kiel University Hospital
Kiel
About this study
Official title: A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.
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.
- Being tested
- Afamelanotide (CUV1647), Placebo
- Keywords
- Actinic keratoses (AK), Squamous cell carcinomas (SCC), CUV1647, Afamelanotide, Clinuvel, Photoprotection, Organ transplant
- Medical subject headings
- Keratosis, Actinic, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afamelanotide (CUV1647)Drug
16 mg subcutaneous implant administered every 60 days
PlaceboDrug
Placebo subcutaneous implant administered every 60 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months Receives: Drug: Afamelanotide (CUV1647) |
| 2 | Placebo comparator | Placebo implant administered subcutaneously every 60 days for 24 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 24 months
To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group
Measured: 24 months
To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startNov 2007
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Günther Hofbauer, M.D., Principal investigator, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829192
- Sponsor's protocol ID
- CUV011
- Status last verified
- Dec 2010
- First submitted
- 23 Jan 2009
- Last updated
- 6 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.
- ClinicalTrials.gov ID
- NCT00829192
- Acronym / sponsor ID
- CUV011
- Keywords
- Actinic keratoses (AK), Squamous cell carcinomas (SCC), CUV1647, Afamelanotide, Clinuvel, Photoprotection, Organ transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clinuvel Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Afamelanotide (CUV1647)Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months |
| 2 | Placebo comparator | Drug: PlaceboPlacebo implant administered subcutaneously every 60 days for 24 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afamelanotide (CUV1647)16 mg subcutaneous implant administered every 60 days | Drug | 1 |
| PlaceboPlacebo subcutaneous implant administered every 60 days | Drug | 2 |
Primary outcome
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
3 secondary outcomes
To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)
Time frame: 24 months
To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group
Time frame: 24 months
To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Günther Hofbauer, M.D. principal investigator
Universitätsspital Zürich
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afamelanotide (CUV1647) in people with Actinic Keratoses and Carcinoma, Squamous Cell, run by Clinuvel Pharmaceuticals Limited at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, Belgium, Germany, Italy, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2010.