Study to Evaluate the Safety & Efficacy of Afamelanotide in Patients With

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
	Status	Clinical Trial	Phase
	Terminated	`NCT02922413` - Panhematin for Prevention of Acute Attacks of Porphyria	Phase 2
	Active, not recruiting	`NCT02935400` - Acute Porphyria Biomarkers for Disease Activity

NCT number	NCT05854784
Study type	Interventional
Source	Clinuvel Pharmaceuticals Limited
Contact
Status	Completed
Phase	Phase 2
Start date	March 28, 2023
Completion date	December 28, 2023

Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms