Pharmacokinetics of Afamelanotide in Erythropoietic Proto... | NCT06388642

Studies
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

NCT06388642

Sponsor

Clinuvel Europe Limited

Status

Completed

Last Update Posted

Mar 25, 2026Actual

Enrollment

28Actual

Phase

Phase 1Phase 2

Conditions

Erythropoietic Protoporphyria

Interventions

Afamelanotide 16mg implant

Countries

Belgium
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2024Actual

Primary Completion Date

Oct 28, 2024Actual

Completion Date

Jan 20, 2025Actual

First Submitted Date

Apr 4, 2024

First Submission Date that Met QC Criteria

Apr 24, 2024

First Posted Date

Apr 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Mar 24, 2026

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Oct 27, 2025

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Afamelanotide 16 mg implant	Experimental		Drug: Afamelanotide 16mg implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Afamelanotide 16mg implant	Drug	afamelanotide 16mg implant will be administered to each patient during the study.	Afamelanotide 16 mg implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax (maximum Plasma Concentration)	Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.	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.	Baseline to Day 7

Secondary Outcomes

Measure	Description	Time Frame
AUC(0-∞) (area under the curve extrapolated to infinite time)		Baseline to Day 7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

EPP patients aged between 12 and 70 years
BMI between 15 and 30 kg/m2
>50 kg

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CLINUVEL Site		Leuven			Belgium
CLINUVEL Site

Submission Tracking

Estimated Results First Submitted Date

Mar 24, 2026

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 24, 2026			Apr 9, 2026	5
May 1, 2026

Condition Browse Module

MeSH Terms

ID	Term
D046351	Protoporphyria, Erythropoietic

Ancestor Terms

ID	Term
D017094	Porphyrias, Hepatic
D008107	Liver Diseases
D004066	Digestive System Diseases
D012873	Skin Diseases, Genetic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C534526	afamelanotide
D004343	Drug Implants

Ancestor Terms

ID	Term
D003692	Delayed-Action Preparations
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided