Polymorphic Light EruptionPhase 3NCT04704713
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
A Phase 3 study testing Afamelanotide in people with Polymorphic Light Eruption, run by Clinuvel Pharmaceuticals Limited.
Trial summary
This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polymorphic Light Eruption
- What is being tested?
- Afamelanotide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2010to 9 Dec 2010
- Phase
- Phase 3
- 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
- Aged greater than 18 years
- Male or female patients with a documented history of PLE diagnosed or confirmed by a photodermatologist or photobiologist, with a history of PLE related pruritus symptoms.
- Recurrent PLE episodes that occur at least once a year (as evidenced by PLE related pruritus symptoms) developing in their own country (to exclude patients affected only when traveling to sunnier climates)
- Written informed consent prior to the performance of any study-specific procedure
- Are willing and able to comply with the conditions specified in the protocol and study procedures in the opinion of the Investigator
Who cannot join
- Currently requiring treatment with systemic immunosuppressive agents
- Documented history of other photosensitivity conditions which may be confused with PLE or interfere with the assessment of PLE episodes
- Solarium use in the three months prior to study involvement and throughout the duration of the study
- Use of immunosuppressive medications, drugs that cause hyperpigmentation or any other treatment that in the opinion of the Investigator may interfere with this study
- Documented presence (> 1 in 320) of Anti-Nuclear Antibody (ANA) and/or positive Extractable Nuclear Antibody (ENA); historical results from the 3 years prior to randomisation are acceptable if available
- In the opinion of the Investigator, any evidence of clinically significant organ dysfunction, or any clinically significant deviation from normal in clinical or laboratory parameters
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- History of drug or alcohol abuse (in the last 1 year)
- Female who is pregnant (confirmed by positive serum beta-Human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating
- Female of child-bearing potential (pre-menopausal, not surgically sterile) that is not using or is not willing to use adequate contraceptive measures (e.g. oral contraceptives, condoms, diaphragm plus spermicide, intrauterine device)
- Sexually active men with partners of child bearing potential not willing to use barrier contraception during the trial and for a period of three months thereafter
- Participation in a clinical trial with another Investigational Medicinal Product (IMP) within 30 days prior to the Screening visit or during the study
- Hypersensitivity to afamelanotide or any of its components
About this study
Official title: A Phase III, Randomised, Double Blind, Placebo Controlled, Parallel Group Study, to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide (16 mg) in Patients Suffering From Polymorphic Light Eruption (PLE)
This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).
- Conditions
- Polymorphic Light Eruption
- 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 group | Role | What they receive |
|---|---|---|
| Afamelanotide | Experimental | Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Receives: Drug: Afamelanotide |
| Placebo | Placebo comparator | Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale
PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus).
Measured: From Day 0 to Day 120
Secondary outcomes (3)
Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries
Measured: From Day 0 to Day 120
Duration of PLE Episodes Recorded in Paper Patient Diaries
Measured: From Day 0 to Day 120
Quality of Life Using the Dermatology Life Quality Index (DLQI)
The DLQI questionnaire consists of 10 questions, each answered on a categorical scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: At Day 0, Day 60 and Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start5 May 2010
- Primary completion9 Dec 2010
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 Polymorphic Light EruptionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704713
- Sponsor's protocol ID
- CUV032
- Status last verified
- Feb 2021
- First submitted
- 8 Jan 2021
- Last updated
- 19 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double Blind, Placebo Controlled, Parallel Group Study, to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide (16 mg) in Patients Suffering From Polymorphic Light Eruption (PLE)
- ClinicalTrials.gov ID
- NCT04704713
- Acronym / sponsor ID
- CUV032
- Conditions
- Polymorphic Light Eruption
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Clinuvel Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 May 2010 (actual)
- Primary completion
- 9 Dec 2010 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Posted 19 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).
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: AfamelanotideAfamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged greater than 18 years
- Male or female patients with a documented history of PLE diagnosed or confirmed by a photodermatologist or photobiologist, with a history of PLE related pruritus symptoms.
- Recurrent PLE episodes that occur at least once a year (as evidenced by PLE related pruritus symptoms) developing in their own country (to exclude patients affected only when traveling to sunnier climates)
- Written informed consent prior to the performance of any study-specific procedure
- Are willing and able to comply with the conditions specified in the protocol and study procedures in the opinion of the Investigator
Key exclusion criteria (12 listed)
- Currently requiring treatment with systemic immunosuppressive agents
- Documented history of other photosensitivity conditions which may be confused with PLE or interfere with the assessment of PLE episodes
- Solarium use in the three months prior to study involvement and throughout the duration of the study
- Use of immunosuppressive medications, drugs that cause hyperpigmentation or any other treatment that in the opinion of the Investigator may interfere with this study
- Documented presence (> 1 in 320) of Anti-Nuclear Antibody (ANA) and/or positive Extractable Nuclear Antibody (ENA); historical results from the 3 years prior to randomisation are acceptable if available
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
Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale
Time frame: From Day 0 to Day 120
PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus).
3 secondary outcomes
Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries
Time frame: From Day 0 to Day 120
Duration of PLE Episodes Recorded in Paper Patient Diaries
Time frame: From Day 0 to Day 120
Quality of Life Using the Dermatology Life Quality Index (DLQI)
Time frame: At Day 0, Day 60 and Day 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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 3 study testing Afamelanotide in people with Polymorphic Light Eruption, 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 5 inclusion and 12 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 19 Mar 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Mar 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?
Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale (time frame: From Day 0 to Day 120). 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 19 Mar 2021.