Rare disease · Phase 3
Afamelanotide: European EPP trial
What was tested?
Afamelanotide versus placebo in people with erythropoietic protoporphyria. ↗
Registered primary question: Direct sunlight exposure without phototoxicity-related pain between 10:00 and 15:00, from baseline through day 270. ↗
What the reviewed report found
Journal year 2015 · Article summary reviewed 2026-09-20
Median pain-free sunlight exposure was 6.0 hours with afamelanotide versus 0.8 hours with placebo over nine months. The report also counted 77 versus 146 phototoxic reactions.↗
Keep in context: This European protocol used a different daily sunlight window and follow-up period from the US trial in the same paper. The exposure-hour totals are not directly comparable across studies. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 74 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 18 Years to 70 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2021-10-12; 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: European placebo-controlled trial
- Design in the report
- A randomized, double-blind, placebo-controlled trial followed pain-free sunlight exposure over nine months.↗
- Participants in the report
- The abstract reports 74 participants with erythropoietic protoporphyria in the European trial.↗
- Limitations
- Exposure measurements and follow-up differ from the US trial. The abstract summarizes safety across both trials, so its overall safety statement is not a separate European-trial estimate or proof about uncommon long-term harms.↗
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 (EPP) ↗
Protocol identifier: CUV029. Sponsor: Clinuvel Pharmaceuticals Limited.
Retrieved 2026-09-20; SHA-256 a546bc313352319832ca0e96a05297ad2e3046b0e746e666df857c49b9d9ce27.
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.