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Afamelanotide

Clinical trials are studying Afamelanotide in several patient groups, including early Parkinson’s disease, stroke, erythropoietic protoporphyria, vitiligo, and healthy volunteers. These studies mainly look at safety, efficacy, and how the body handles the treatment. The trials include different phases, from Phase 1 to Phase 4.

Table of Contents

Clinical trial overview

The trial data show that Afamelanotide is being studied in different clinical settings, not as a general medicine description, but as a research treatment in specific trials.[1][2][3][4][5][6]

Across the listed studies, the targets include Parkinson’s disease, arterial ischaemic stroke, erythropoietic protoporphyria, vitiligo, and healthy volunteers.[1][2][3][4][5][6]

The studies include Phase 1, Phase 2, and Phase 4 research, which means the program includes early testing, mid-stage testing, and later comparative research.[1][2][3][4][5][6]

Most trials are interventional, meaning the researchers give a treatment and then measure what happens.[1][2][3][4][5][6]

Early Parkinson’s disease studies

Two trials studied Afamelanotide in people with early Parkinson’s disease.[1][6]

One was a Phase 2a open-label study focused on safety and was marked Withdrawn, with planned enrollment of 10 participants.[1]

The other was a Phase 2 proof-of-concept study that was completed and enrolled 6 participants.[6]

In both Parkinson’s studies, the main goal was to assess treatment-emergent adverse events, which are health problems that appear after treatment starts, and to look at clinically significant changes in laboratory results.[1][6]

A proof-of-concept study means an early trial that checks whether a treatment seems promising enough to study further.[6]

Stroke study

One Phase 2 study looked at Afamelanotide in people with acute arterial ischaemic stroke (AIS), and it was completed with 12 enrolled participants.[2]

This study was a safety study, and the main outcome was the monitoring and recording of treatment-emergent adverse events.[2]

Acute stroke means the study focused on the early period after the stroke event.[2]

Erythropoietic protoporphyria study

One Phase 1 study in erythropoietic protoporphyria (EPP) was completed and enrolled 34 adolescent and adult participants.[3]

The study aimed to determine the pharmacokinetics of Afamelanotide, which means how the body processes the treatment over time.[3]

The trial also aimed to compare the pharmacokinetic profiles in adolescent and adult EPP patients.[3]

The primary outcomes were Cmax and AUC(0-t), two measures of drug exposure in the body.[3]

Healthy volunteer study

One Phase 2 mechanistic study was authorised in healthy volunteers and planned to enroll 10 participants.[4]

A mechanistic study looks at how a treatment affects a biological process, not just whether it helps a disease.[4]

This trial examined the impact of Afamelanotide in aqueous solution on ultraviolet radiation-induced DNA damage and DNA repair capacity in skin.[4]

The primary outcome was the change in UV photoproducts before and after treatment in UV-exposed skin and in non-irradiated skin.[4]

Vitiligo study

One large study in vitiligo was authorised as a Phase 4 open-label trial and planned to enroll 200 participants.[5]

This study compared SCENESSE and narrow-band ultraviolet B (NB-UVB) light versus NB-UVB light alone.[5]

NB-UVB is a form of light treatment used in skin disease, and the trial tested whether adding SCENESSE improved repigmentation.[5]

The main outcome was the percentage of participants who achieved repigmentation, meaning return of skin color, in the combination group compared with the light-only group.[5]

Main outcomes measured

Several different outcomes were used across the Afamelanotide trials, depending on the condition and study phase.[1][2][3][4][5][6]

  • Safety outcomes: These included treatment-emergent adverse events and clinically significant laboratory changes in Parkinson’s disease and stroke studies.[1][2][6]
  • Pharmacokinetic outcomes: In EPP, the study measured Cmax and AUC(0-t) to understand exposure to the treatment.[3]
  • Biological effect outcomes: In healthy volunteers, the study measured UV photoproduct changes to see the effect on DNA damage and repair.[4]
  • Clinical effect outcomes: In vitiligo, the study measured repigmentation to see whether the treatment combination improved skin color return.[5]

The trial set shows that Afamelanotide is being explored for both safety and possible benefit in different patient groups, with study goals matched to each condition.[1][2][3][4][5][6]

Trial ID Phase Condition studied Status Enrollment
2023-507311-35-00 Phase 1 Erythropoietic Protoporphyria (EPP) Completed 34
NCT06109649 Phase 4 Vitiligo Authorised 200
2022-500919-40-01 Phase 2 Arterial Ischaemic Stroke (AIS) Completed 12
2022-502207-30-00 Phase 2 Parkinson’s Disease Withdrawn 10
2022-502207-30-01 Phase 2 Parkinson’s Disease Completed 6
2023-505907-21-00 Phase 2 Healthy volunteers Authorised 10

FAQ

  • What is being studied in Afamelanotide clinical trials? The trials study safety, efficacy, pharmacokinetics, and biological effects. They look at conditions such as Parkinson's disease, stroke, erythropoietic protoporphyria, vitiligo, and UV-related skin damage.
  • Who can take part in these trials? Participants include people with early Parkinson's disease, acute arterial ischaemic stroke, erythropoietic protoporphyria, vitiligo, and healthy volunteers. Each trial has its own entry rules.
  • What trial phases are included? The trials include Phase 1, Phase 2, and Phase 4 studies. This means the research ranges from early testing to later studies that compare treatment options.
  • What are the main goals of the trials? Some trials check safety by tracking treatment-emergent adverse events and lab changes. Others measure treatment effect, DNA damage changes, repigmentation, or drug exposure in the body.
  • Are all Afamelanotide trials completed? No. Some studies are completed, while others are authorised or withdrawn. The status depends on the specific trial.

Ongoing Clinical Trials on Afamelanotide

  • Study on the Effects of Afamelanotide on UV Radiation-Induced DNA Damage and Repair in Healthy Volunteers

    Not yet recruiting

    2 1 1
    Investigated drugs:
    Germany

  • Safety Study of Afamelanotide for Patients with Early Parkinson’s Disease

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Afamelanotide for Patients with Erythropoietic Protoporphyria (EPP)

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium The Netherlands

  • Study on Afamelanotide and NB-UVB Light for Vitiligo Treatment in Patients with Vitiligo

    Not recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy

  • Study on the Safety and Effects of Afamelanotide for Patients with Early Parkinson’s Disease

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Safety of Afamelanotide for Patients with Acute Arterial Ischemic Stroke Ineligible for Standard Stroke Treatments

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Phase 1: An early study stage that usually looks at how the treatment behaves in the body and may also check safety.
  • Phase 2: A study stage that often looks more closely at safety and whether the treatment may help the condition being studied.
  • Phase 4: A later study stage that compares treatments in real-world or larger patient groups.
  • Open label: A study design where both the participants and the researchers know what treatment is being given.
  • Interventional study: A trial where researchers give a treatment and then measure its effects.
  • Treatment-emergent adverse events: Health problems that start or get worse after the treatment begins.
  • Laboratory results: Blood or other test results that help show how the body is responding to treatment.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment over time.
  • Cmax: The highest level of a treatment measured in the blood.
  • AUC(0-t): A measure of total drug exposure over a period of time.
  • Repigmentation: Return of skin color in areas that have lost pigment.
  • UV photoproducts: Changes in DNA caused by ultraviolet light exposure.

References

  1. https://clinicaltrials.gov/study/2022-502207-30-00
  2. https://clinicaltrials.gov/study/2022-500919-40-01
  3. https://clinicaltrials.gov/study/2023-507311-35-00
  4. https://clinicaltrials.gov/study/2023-505907-21-00
  5. https://clinicaltrials.eu/trial/study-on-afamelanotide-and-nb-uvb-light-for-vitiligo-treatment-in-patients-with-vitiligo/
  6. https://clinicaltrials.gov/study/2022-502207-30-01