A study to evaluate the pharmacokinetics of Afamelanotide in patients with erythropoietic protoporphyria (EPP).
Résumé de l'étude
The aim of the CUV052 study is to determine the pharmacokinetics of Afamelanotide in patients with EPP (adolescent and adult patients) and to test the safety and tolerability of Afamelanotide in both adult and adolescent EPP patients. Afamelanotide is a synthetically produced chemical that is very similar to the natural human hormone Alpha-Melanocyte-Stimulating Hormone (α-MSH). Afamelanotide acts similarly to the natural hormone that increases skin melanization. In EPP patients, Afamelanotide activates the production of eumelanin in the melanocytes without prior cell damage in response to UV radiation. This increased production of eumelanin provides EPP patients with light protection, aiming to reduce the number and severity of phototoxic reactions they experience due to this disease while improving their quality of life. SCENESSE® (Afamelanotide 16mg implant) is approved for the treatment of EPP patients aged 18 years and older in the EU, Australia, and the USA. Each patient receives an Afamelanotide implant and is monitored over a period of 90 days. Throughout the study, patients will also undergo safety assessments, including blood and urine analyses, vital signs, and checks of concomitant medication and adverse events.
(BASEC)
Intervention étudiée
SCENESSE® (Afamelanotide 16 mg implant)
(BASEC)
Maladie en cours d'investigation
Erythropoietic Protoporphyria (EPP)
(BASEC)
• Fourteen adult EPP patients aged between 18 and 70 years (inclusive) and fourteen EPP adolescents aged between 12 and 17 years (inclusive). • >50 kg • Participants are able and willing to comply with the protocol requirements, including refraining from the use of tanning products and excessive exposure to ultraviolet (UV) light from the start of the study until day 90. (BASEC)
Critères d'exclusion
• Significant history of allergies and/or sensitivity to any of the components of the investigational medicinal product. • Administration of Afamelanotide in the last 60 days • Donation of 400 ml or more of blood or significant blood loss in the eight weeks prior to screening. (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
CLINUVEL AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Head of Clinical Operations
+44 1372 860 765
mail@clutterclinuvel.comCLINUVEL UK
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
12.03.2024
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients with Erythropoietic Protoporphyria (EPP) (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
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Critères d'inclusion/exclusion
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non disponible
Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
cuv052-laypersons-summary-of-results-de.pdfLien vers les résultats dans le registre primaire
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