Rare disease · Phase 3
Afamelanotide: US EPP trial
What was tested?
Afamelanotide versus placebo in people with erythropoietic protoporphyria. ↗
Registered primary question: Direct sunlight exposure without pain between 10:00 and 18:00, recorded daily for six months. ↗
What the reviewed report found
Journal year 2015 · Article summary reviewed 2026-09-20
Median pain-free sunlight exposure was 69.4 hours with afamelanotide versus 40.8 hours with placebo over six months.↗
Keep in context: The registry reports 93 enrolled participants while the abstract reports 94. That discrepancy remains explicit. The US and European protocols used different daily sunlight windows and follow-up periods. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 93 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 18 Years; maximum not specified
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2019-09-19; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
EPP: US placebo-controlled trial
- Design in the report
- A randomized, double-blind, placebo-controlled trial followed pain-free sunlight exposure over six months.↗
- Participants in the report
- The abstract reports 94 participants with erythropoietic protoporphyria in the US trial.↗
- Limitations
- Exposure measurements and follow-up differ from the European trial. The numeric exposure results should not be directly compared across trials. The abstract’s overall safety statement covers both studies.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
Phase III Confirmatory Study in Erythropoietic Protoporphyria ↗
Protocol identifier: CUV039. Sponsor: Clinuvel Pharmaceuticals Limited.
Retrieved 2026-09-20; SHA-256 a64e40396d586141a8ff60a2a326ac883841bdd90f87b74c93fe431ec890bad0.
PMID 26132941
Afamelanotide for Erythropoietic Protoporphyria. ↗
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch XML; locate MedlineCitation/PMID 26132941. SHA-256 b94a37b2a147aaedfdcff20011049a0589c73cd3790c0e727e5e8a209b2d802f.
Scientific summary uses the original 2026-09-20 source snapshot: SHA-256 b94a37b2a147aaedfdcff20011049a0589c73cd3790c0e727e5e8a209b2d802f.