A Phase 1/2 interventional study of Afamelanotide 16mg implant in Erythropoietic Protoporphyria, sponsored by Clinuvel Europe Limited. Completed at 2 sites in 2 countries. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Clinuvel Europe Limited · Phase 1/2, Interventional, and Other
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The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.
29 studies on the registry are indexed under Protoporphyria, Erythropoietic; 5 are open to participants now.
This study's enrollment of 28 is below the median of 62 across 20 interventional studies indexed under Protoporphyria, Erythropoietic.
Browse Protoporphyria, Erythropoietic studies →Clinuvel Europe Limited is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Afamelanotide 16mg implant
afamelanotide 16mg implant will be administered to each patient during the study.
Also known as: SCENESSE®
Cmax (Maximum Plasma Concentration)
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
Time frame: Baseline to Day 7
AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t)
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
Time frame: Baseline to Day 7
AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)
Time frame: Baseline to Day 7
| Milestone | Afamelanotide 16 mg Implant |
|---|---|
| Started | 28 |
| Completed | 28 |
| Not completed | 0 |
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
| ng/mL | Afamelanotide 16 mg Implant |
|---|---|
| Cmax (Maximum Plasma Concentration) | 2.361 (1.85 to 3.013) |
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
| h*ng/mL | Afamelanotide 16 mg Implant |
|---|---|
| AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t) | 95.415 (77.075 to 118.119) |
| h*ng/mL | Afamelanotide 16 mg Implant |
|---|---|
| AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time) | 114.406 (96.631 to 135.45) |
Collected over All adverse events were monitored from baseline until 3 months after treatment (approximately 3 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Afamelanotide 16 mg Implant | 0/28 (0%) | 0/28 (0%) | 23/28 (82.1%) |
| Event | Afamelanotide 16 mg Implant |
|---|---|
| HeadacheNervous system disorders | 6/28 |
| NauseaGastrointestinal disorders | 4/28 |
| Influenza like illnessGeneral disorders | 4/28 |
| DiarrhoeaGastrointestinal disorders | 3/28 |
| Rhinitis*Infections and infestations | 3/28 |
| Photosensitivity reaction*Skin and subcutaneous tissue disorders | 3/28 |
| Implant Site haematoma*General disorders | 2/28 |
| Age, Categorical(Participants) | Afamelanotide 16 mg Implant |
|---|---|
| <=18 years | 14 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Afamelanotide 16 mg Implant |
|---|---|
| Female | 12 |
| Male | 16 |
| Race and Ethnicity Not Collected(Participants) | Afamelanotide 16 mg Implant |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2024 to primary completion in Oct 2024, 7 months.
Results were first posted in Jul 2026, 1 year 8 months after primary completion. A results delay was requested in Oct 2025.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Afamelanotide
Protoporphyria, Erythropoietic →
Clinuvel Europe Limited