Trial Outcomes & Findings for Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients (NCT NCT06388642)
NCT ID: NCT06388642
Last Updated: 2026-07-27
Results Overview
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline to Day 7
Results posted on
2026-07-27
Participant Flow
Participant milestones
| Measure |
Afamelanotide 16 mg Implant
Afamelanotide 16mg implant: afamelanotide 16mg implant will be administered to each patient during the study.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Afamelanotide 16 mg Implant
n=28 Participants
Afamelanotide 16mg implant: afamelanotide 16mg implant will be administered to each patient during the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 7Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
Outcome measures
| Measure |
Afamelanotide 16 mg Implant
n=28 Participants
Afamelanotide 16mg implant: afamelanotide 16mg implant will be administered to each patient during the study.
|
|---|---|
|
Cmax (Maximum Plasma Concentration)
|
2.361 ng/mL
Interval 1.85 to 3.013
|
PRIMARY outcome
Timeframe: Baseline to Day 7Blood samples will be collected for analysis of afamelanotide plasma concentrations.
Outcome measures
| Measure |
Afamelanotide 16 mg Implant
n=28 Participants
Afamelanotide 16mg implant: afamelanotide 16mg implant will be administered to each patient during the study.
|
|---|---|
|
AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t)
|
95.415 h*ng/mL
Interval 77.075 to 118.119
|
SECONDARY outcome
Timeframe: Baseline to Day 7Outcome measures
| Measure |
Afamelanotide 16 mg Implant
n=28 Participants
Afamelanotide 16mg implant: afamelanotide 16mg implant will be administered to each patient during the study.
|
|---|---|
|
AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)
|
114.406 h*ng/mL
Interval 96.631 to 135.45
|
Adverse Events
Afamelanotide 16 mg Implant
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Afamelanotide 16 mg Implant
n=28 participants at risk
Afamelanotide 16mg implant: afamelanotide 16mg implant will be administered to each patient during the study.
|
|---|---|
|
Nervous system disorders
Headache
|
21.4%
6/28 • Number of events 7 • All adverse events were monitored from baseline until 3 months after treatment (approximately 3 months)
Participants were advised to report any adverse events to the PI. Photosensitivity reaction is an expected event in EPP patients, the protocol did not specify that such reactions related to EPP should be excluded from AE collection. All of the AEs marked with asterisk (\*) were assessed as unrelated to treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
4/28 • Number of events 4 • All adverse events were monitored from baseline until 3 months after treatment (approximately 3 months)
Participants were advised to report any adverse events to the PI. Photosensitivity reaction is an expected event in EPP patients, the protocol did not specify that such reactions related to EPP should be excluded from AE collection. All of the AEs marked with asterisk (\*) were assessed as unrelated to treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
3/28 • Number of events 3 • All adverse events were monitored from baseline until 3 months after treatment (approximately 3 months)
Participants were advised to report any adverse events to the PI. Photosensitivity reaction is an expected event in EPP patients, the protocol did not specify that such reactions related to EPP should be excluded from AE collection. All of the AEs marked with asterisk (\*) were assessed as unrelated to treatment.
|
|
General disorders
Influenza like illness
|
14.3%
4/28 • Number of events 5 • All adverse events were monitored from baseline until 3 months after treatment (approximately 3 months)
Participants were advised to report any adverse events to the PI. Photosensitivity reaction is an expected event in EPP patients, the protocol did not specify that such reactions related to EPP should be excluded from AE collection. All of the AEs marked with asterisk (\*) were assessed as unrelated to treatment.
|
|
General disorders
Implant Site haematoma*
|
7.1%
2/28 • Number of events 2 • All adverse events were monitored from baseline until 3 months after treatment (approximately 3 months)
Participants were advised to report any adverse events to the PI. Photosensitivity reaction is an expected event in EPP patients, the protocol did not specify that such reactions related to EPP should be excluded from AE collection. All of the AEs marked with asterisk (\*) were assessed as unrelated to treatment.
|
|
Infections and infestations
Rhinitis*
|
10.7%
3/28 • Number of events 3 • All adverse events were monitored from baseline until 3 months after treatment (approximately 3 months)
Participants were advised to report any adverse events to the PI. Photosensitivity reaction is an expected event in EPP patients, the protocol did not specify that such reactions related to EPP should be excluded from AE collection. All of the AEs marked with asterisk (\*) were assessed as unrelated to treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction*
|
10.7%
3/28 • Number of events 6 • All adverse events were monitored from baseline until 3 months after treatment (approximately 3 months)
Participants were advised to report any adverse events to the PI. Photosensitivity reaction is an expected event in EPP patients, the protocol did not specify that such reactions related to EPP should be excluded from AE collection. All of the AEs marked with asterisk (\*) were assessed as unrelated to treatment.
|
Additional Information
Director, Global Clinical Affairs
CLINUVEL EUROPE LTD
Phone: +4401372860765
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place