Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

NCT04704713 | Completed Phase 3 Results

• 1 other identifier: CUV032
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).

Conditions

Polymorphic Light Eruption

Outcome Measures

Primary Outcomes (1)

• 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).

  From Day 0 to Day 120

Secondary Outcomes (3)

• Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries

  From Day 0 to Day 120

• Duration of PLE Episodes Recorded in Paper Patient Diaries

  From Day 0 to Day 120

• Quality of Life Using the Dermatology Life Quality Index (DLQI)

  At Day 0, Day 60 and Day 120

Study Arms (2)

Afamelanotide

EXPERIMENTAL

Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.

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.

Drug: Placebo

Interventions

Afamelanotide DRUG

Afamelanotide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

MeSH Terms

Interventions

afamelanotide

Results Point of Contact

• Title: Clinical Operations Manager
• Organization: CLINUVEL PHARMACEUTICALS LIMITED

mail@clinuvel.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: May 5, 2010
• Primary Completion: December 9, 2010
• Last Updated: March 19, 2021
• Results First Posted: March 19, 2021

Record last verified: 2021-02