Patients Undergoing Photodynamic Therapy Using Porfimer SodiumPhase 2NCT04425746

Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

A Phase 2 study testing Afamelanotide in people with Patients Undergoing Photodynamic Therapy Using Porfimer Sodium, run by Clinuvel Pharmaceuticals Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
What is being tested?: Afamelanotide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: No sites listed yet
Study dates: 5 Aug 2008to 28 May 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
Aged greater than 18 years;
Written informed consent prior to the performance of any study-specific procedure.

Who cannot join

Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
Non-Caucasian patients;
Personal history of melanoma or dysplastic nevus syndrome;
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 β-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);

Show all 9Show fewer

Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit;
Patients unable to give informed consent;
Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.

About this study

Official title: A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 (Afamelanotide) as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

Conditions: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Being tested: Afamelanotide, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AfamelanotideDrug
PlaceboDrug

Study groups in NCT04425746
Study group	Role	What they receive
Afamelanotide	Experimental	Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity. Receives: Drug: Afamelanotide
Placebo	Placebo comparator	Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
Measured: From Day 04 to Day 90

Secondary outcomes (1)

Change in Quality of Life
Quality of life, as measured by the Short Form-36 Health survey (SF-36) (quality of life questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: From Day 0 to Day 20, Day 60 and Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 200828 May 2009

First posted11 Jun 2020
Study start5 Aug 2008
Primary completion28 May 2009
Study completion28 May 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Patients Undergoing Photodynamic Therapy Using Porfimer SodiumStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04425746
Sponsor's protocol ID: CUV025
Status last verified: Sep 2021
First submitted: 8 Jun 2020
Last updated: 1 Oct 2021
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 (Afamelanotide) as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
ClinicalTrials.gov ID: NCT04425746
Acronym / sponsor ID: CUV025
Conditions: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Clinuvel Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
Study start: 5 Aug 2008 (actual)
Primary completion: 28 May 2009 (actual)
Study completion: 28 May 2009 (actual)
First posted: 11 Jun 2020 (actual)
Results: Posted 1 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Afamelanotide	Experimental	Drug: AfamelanotideSubjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
Placebo	Placebo comparator	Drug: PlaceboSubjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
Aged greater than 18 years;
Written informed consent prior to the performance of any study-specific procedure.

Key exclusion criteria (9 listed)

Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
Non-Caucasian patients;
Personal history of melanoma or dysplastic nevus syndrome;
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 β-HCG pregnancy test prior to baseline) or lactating;

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	Drug	Afamelanotide
Placebo	Drug	Placebo

Primary outcome

The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
Time frame: From Day 04 to Day 90

1 secondary outcome

Change in Quality of Life
Time frame: From Day 0 to Day 20, Day 60 and Day 90

Results and safety

Results posted to the registry on 1 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afamelanotide	9	9
Placebo	7	6

Primary outcome: The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting

Time frame: From Day 04 to Day 90

Population analysed: The planned primary efficacy endpoint was the number of days for patients to be free of phototoxic reactions following phototesting. This was recorded by patients through diaries, however these diaries were not completed appropriately, thus data could not be collected. Thus, the efficacy analysis was performed using the secondary efficacy endpoint, change in quality of life as measured by SF-36.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afamelanotide	2 of 9 (22.2%)	6 of 9 (66.7%)	Not reported
Placebo	3 of 7 (42.9%)	1 of 7 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Afamelanotide in people with Patients Undergoing Photodynamic Therapy Using Porfimer Sodium, run by Clinuvel Pharmaceuticals Limited.

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 3 inclusion and 9 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: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 1 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting (time frame: From Day 04 to Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04425746.

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 1 Oct 2021.