A Phase 2 interventional study of Afamelanotide in Xeroderma Pigmentosum, sponsored by Clinuvel Europe Limited. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Clinuvel Europe Limited · Phase 2, Interventional, and Treatment
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The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.
Clinuvel Europe Limited is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Afamelanotide
Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.
Change in minimal erythema dose (MED) in patients with XP-C.
MED is the lowest dose of UV light that causes reddening of the skin.
Time frame: From baseline to day 76.
Change in MED in patients with XP-V.
MED is the lowest dose of UV light that causes reddening of the skin.
Time frame: From baseline to day 76.
Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-C.
Analysis of UV photoproducts from skin samples.
Time frame: From baseline to day 76.
Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-C.
Analysis of DNA repair mechanisms from skin samples.
Time frame: From baseline to day 76.
Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-V.
Analysis of UV photoproducts from skin samples.
Time frame: From baseline to day 76.
Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-V.
Analysis of DNA repair mechanisms from skin samples.
Time frame: From baseline to day 76.
Change in skin disease severity in patients with XP-C (A).
The higher the score, the more severe the disease.
Time frame: From baseline to day 76.
Change in skin disease severity in patients with XP-V (A)
The higher the score, the more severe the disease.
Time frame: From baseline to day 76.
Change in skin disease severity in patients with XP-C (B).
The higher the score, the more severe the disease.
Time frame: From baseline to day 76.
Change in skin disease severity in patients with XP-V (B).
The higher the score, the more severe the disease.
Time frame: From baseline to day 76.
Change in skin disease severity in patients with XP-C (C).
The higher the score, the more severe the disease.
Time frame: From baseline to day 76.
Change in skin disease severity in patients with XP-V (C).
The higher the score, the more severe the disease.
Time frame: From baseline to day 76.
Change in quality of life assessed by a disease specific tool (A) in patients with XP-C.
Higher scores represent worse health-related quality of life.
Time frame: From baseline to day 76.
Change in quality of life assessed by a disease specific tool (A) in patients with XP-V.
Higher scores represent worse health-related quality of life.
Time frame: From baseline to day 76.
Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-C.
Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.
Time frame: From baseline to day 76.
Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-V.
Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.
Time frame: From baseline to day 76.
Started Mar 2022 (actual). Primary completion is estimated for Jun 2024, 27 months after the start.
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Studies of the drug tested here: Afamelanotide
Xeroderma Pigmentosum