A study to evaluate the pharmacokinetics of Afamelanotide in patients with erythropoietic protoporphyria (EPP).
Descrizione riassuntiva dello studio
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)
Intervento studiato
SCENESSE® (Afamelanotide 16 mg implant)
(BASEC)
Malattie studiate
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)
Criteri di esclusione
• 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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
CLINUVEL AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Head of Clinical Operations
+44 1372 860 765
mail@clutterclinuvel.comCLINUVEL UK
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
12.03.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients with Erythropoietic Protoporphyria (EPP) (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
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Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
cuv052-laypersons-summary-of-results-de.pdfLink ai risultati nel registro primario
non disponibile