Phase 3
N=31
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
Polymorphic Light Eruption
Bottom Line
View on ClinicalTrials.gov: NCT04704713 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale — 0.25; 0.47 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Afamelanotide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clinuvel Pharmaceuticals Limited
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale |
0.25; 0.47 | — |
| SECONDARY Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries |
— | — |
| SECONDARY Duration of PLE Episodes Recorded in Paper Patient Diaries |
— | — |
| SECONDARY Quality of Life Using the Dermatology Life Quality Index (DLQI) |
— | — |
Summary
This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04704713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.