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Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

Primary Purpose

Polymorphic Light Eruption

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Afamelanotide
Placebo
Sponsored by
Clinuvel Pharmaceuticals Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymorphic Light Eruption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Afamelanotide

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 8, 2021
    Last Updated
    February 25, 2021
    Sponsor
    Clinuvel Pharmaceuticals Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04704713
    Brief Title
    Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 5, 2010 (Actual)
    Primary Completion Date
    December 9, 2010 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clinuvel Pharmaceuticals Limited

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polymorphic Light Eruption

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Afamelanotide
    Arm Type
    Experimental
    Arm Description
    Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
    Intervention Type
    Drug
    Intervention Name(s)
    Afamelanotide
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale
    Description
    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).
    Time Frame
    From Day 0 to Day 120
    Secondary Outcome Measure Information:
    Title
    Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries
    Time Frame
    From Day 0 to Day 120
    Title
    Duration of PLE Episodes Recorded in Paper Patient Diaries
    Time Frame
    From Day 0 to Day 120
    Title
    Quality of Life Using the Dermatology Life Quality Index (DLQI)
    Description
    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.
    Time Frame
    At Day 0, Day 60 and Day 120

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

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