At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 6 enrolled
Drug / intervention
Afamelanotide 16 MGdrug
Likely dose
Afamelanotide 16 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)-Related Skin Disease.
In Brief
A Phase 2 clinical trial evaluating Afamelanotide 16 MG for Variegate Porphyria. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The primary objective is to evaluate the impact of afamelanotide on the severity of skin disease in patients with Variegate Porphyria (VP). The secondary objectives are to evaluate the safety and tolerability of afamelanotide in patients with VP and evaluate the impact of afamelanotide on the quality of life of patients with VP.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVariegate Porphyria
CountriesNetherlands
Collaborators--
Timeline
Phase 2CompletedFinished
202420252026
Enrollment StartMar 2023
First PostedMay 2023
Primary CompletionDec 2023
TodayJul 2026
First PostedMay 11, 2023
Enrollment StartMar 28, 2023
Primary CompletionDec 28, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.1 years ago
Interventions
Afamelanotide 16 MGdrug
Eligible patients will receive one dose of afamelanotide 16mg every 28 days (up to six doses), as a controlled-release formulation.