Erythropoietic ProtoporphyriaPhase 1/2NCT06388642
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
A Phase 1/2 study testing Afamelanotide 16mg implant in people with Erythropoietic Protoporphyria, run by Clinuvel Europe Limited at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Erythropoietic Protoporphyria
- What is being tested?
- Afamelanotide 16mg implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Mar 2024to 20 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- EPP patients aged between 12 and 70 years
- BMI between 15 and 30 kg/m2
- >50 kg
Who cannot join
- Any personal or direct family history of melanoma
- Any significant history of allergy and/or sensitivity to any of the contents of study drug product or lignocaine or other local anaesthetics if used
- Any significant illness during the four weeks before the study screening period
- Any evidence of hepatic or renal impairment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)
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.
- Conditions
- Erythropoietic Protoporphyria
- Being tested
- Afamelanotide 16mg implant
- Medical subject headings
- Protoporphyria, Erythropoietic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afamelanotide 16mg implantDrug
Also called SCENESSE®
afamelanotide 16mg implant will be administered to each patient during the study.
| Study group | Role | What they receive |
|---|---|---|
| Afamelanotide 16 mg implant | Experimental | Not described Receives: Drug: Afamelanotide 16mg implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum Plasma Concentration)
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
Measured: 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.
Measured: Baseline to Day 7
Secondary outcomes (1)
AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)
Measured: Baseline to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start7 Mar 2024
- Primary completion28 Oct 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erythropoietic ProtoporphyriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinuvel Europe Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388642
- Sponsor's protocol ID
- CUV052
- Status last verified
- Jul 2026
- First submitted
- 4 Apr 2024
- Last updated
- 27 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)
- ClinicalTrials.gov ID
- NCT06388642
- Acronym / sponsor ID
- CUV052
- Conditions
- Erythropoietic Protoporphyria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Clinuvel Europe LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Posted 27 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afamelanotide 16 mg implant | Experimental | Drug: Afamelanotide 16mg implant |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- EPP patients aged between 12 and 70 years
- BMI between 15 and 30 kg/m2
- >50 kg
Key exclusion criteria (4 listed)
- Any personal or direct family history of melanoma
- Any significant history of allergy and/or sensitivity to any of the contents of study drug product or lignocaine or other local anaesthetics if used
- Any significant illness during the four weeks before the study screening period
- Any evidence of hepatic or renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afamelanotide 16mg implantAlso: SCENESSE®afamelanotide 16mg implant will be administered to each patient during the study. | Drug | Afamelanotide 16 mg implant |
Primary outcome
Cmax (Maximum Plasma Concentration)
Time frame: Baseline to Day 7
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t)
Time frame: Baseline to Day 7
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
1 secondary outcome
AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)
Time frame: Baseline to Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Afamelanotide 16mg implant in people with Erythropoietic Protoporphyria, run by Clinuvel Europe Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (Maximum Plasma Concentration) (time frame: Baseline to Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.