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Clinical trials for afamelanotide

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    16 result(s) found for: afamelanotide. Displaying page 1 of 1.
    EudraCT Number: 2021-001419-10 Sponsor Protocol Number: CUV152 Start Date*: 2022-01-26
    Sponsor Name:CLINUVEL EUROPE LIMITED
    Full Title: A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients with Xeroderma Pigmentosum C and V (XPC and XPV)
    Medical condition: Patients with Xeroderma Pigmentosum C and V
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-018024-15 Sponsor Protocol Number: CUV100 Start Date*: 2010-05-27
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Mild to Moderate Acne...
    Medical condition: Acne vulgaris
    Disease: Version SOC Term Classification Code Term Level
    12.1 10000519 Acne vulgaris LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000597-34 Sponsor Protocol Number: CUV150 Start Date*: 2021-06-01
    Sponsor Name:CLINUVEL EUROPE LIMITED
    Full Title: A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients with Xeroderma Pigmentosum (XP)
    Medical condition: xeroderma pigmentosum
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-017359-92 Sponsor Protocol Number: CUV032 Start Date*: 2010-05-18
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, randomised, double blind, placebo controlled, parallel group study, to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from pol...
    Medical condition: Polymorphic light eruption (PLE)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036087 Polymorphic light eruption LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-010843-15 Sponsor Protocol Number: CUV026 Start Date*: 2009-10-09
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, randomised, double blind, placebo controlled study to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from polymorphic light er...
    Medical condition: Polymorphic light eruption (PLE)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036087 Polymorphic light eruption PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003642-20 Sponsor Protocol Number: CUV156 Start Date*: 2021-09-27
    Sponsor Name:CLINUVEL EUROPE LTD
    Full Title: A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients with Xeroderma Pigmentosum (XP)
    Medical condition: xeroderma pigmentosum
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-011018-51 Sponsor Protocol Number: CUV029 Start Date*: 2009-08-06
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic ...
    Medical condition: Erythropoietic Protoporphyria (EPP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FI (Completed) GB (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2021-006126-52 Sponsor Protocol Number: CUV803 Start Date*: 2023-02-15
    Sponsor Name:CLINUVEL EUROPE LIMITED
    Full Title: A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Arterial Ischaemic Stroke (AIS) who are ineligible for Intravenous Th...
    Medical condition: Arterial Ischaemic Stroke (AIS)
    Disease: Version SOC Term Classification Code Term Level
    22.1 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-002143-16 Sponsor Protocol Number: CUV023 Start Date*: 2010-02-04
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, multicentre, double–blind, placebo controlled, cross over study to evaluate the safety and efficacy of subcutaneous bioresorbable implants of afamelanotide in the treatment of solar ur...
    Medical condition: Solar urticaria (SU)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10041307 Solar urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004164-60 Sponsor Protocol Number: CUV040 Start Date*: 2022-05-19
    Sponsor Name:CLINUVEL (UK) LTD
    Full Title: A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease.
    Medical condition: Variegate Porphyria (VP)-related skin disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000169-10 Sponsor Protocol Number: CUV101 Start Date*: 2011-04-08
    Sponsor Name:CLINUVEL PHARMACUETICALS LTD.
    Full Title: A Phase II, Randomised Pilot Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegm...
    Medical condition: Subjects affected by non-segmental vitiligo
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10062080 Pigmentation disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005321-40 Sponsor Protocol Number: CUV015 Start Date*: 2007-01-19
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, randomised, double blind, placebo controlled study to evaluate the safety and efficacy of subcutaneous implants of CUV1647 in patients suffering from polymorphic light eruption (PLE).
    Medical condition: Polymorphic light eruption (PLE)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036087 Polymorphic light eruption PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FI (Completed) AT (Completed) BE (Completed) FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004562-33 Sponsor Protocol Number: HHD_SCENESSE Start Date*: 2013-12-17
    Sponsor Name:ISTITUTI FISIOTERAPICI OSPITALIERI
    Full Title: PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTS
    Medical condition: SYMPTOMATIC HHD PATIENTS
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10019029 Hailey-Hailey disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-002446-39 Sponsor Protocol Number: CUV025 Start Date*: 2008-10-16
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 Administered as A Subcutaneous Bioresorbable 16mg Implant in Patients Undergoin...
    Medical condition: Barrett's Oesohagus Cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004137 Barrett's oesophagus LLT
    9.1 10008593 Cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-007015-89 Sponsor Protocol Number: CUV011 Start Date*: 2008-11-07
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of CUV1647 for the Prophylactic Treatment of Pr...
    Medical condition: Pre-cancerous skin lesions
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000614 Actinic keratosis LLT
    9.1 10004146 Basal cell carcinoma LLT
    9.1 10041823 Squamous cell carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) FR (Ongoing) DE (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-000636-13 Sponsor Protocol Number: CUV017 Start Date*: 2008-06-17
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP)
    Medical condition: Erythropoietic Protoporphyria (EPP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) IT (Completed) FR (Completed) DE (Completed) NL (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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