CLINICAL TRIALS PROFILE FOR AFAMELANOTIDE
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All Clinical Trials for Afamelanotide
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00472901 ↗ | Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE) | Completed | Clinuvel Pharmaceuticals Limited | 2007-05-01 | The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients with a well documented history of the disease. The study also aims to determine whether treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group. | |
| NCT00829192 ↗ | Phase II AK Study in Organ Transplant Patients | Unknown status | Clinuvel Pharmaceuticals Limited | Phase 2 | 2007-11-01 | The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period. The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period. |
| NCT00859534 ↗ | Phase II Solar Urticaria (SU) Pilot Study | Completed | Clinuvel Pharmaceuticals Limited | Phase 2 | 2008-12-01 | Urticaria is one of the most common dermatological conditions with diverse clinical presentations and causes. Solar urticaria (SU) is a rare subset of physical urticaria, where symptoms are induced by direct exposure of the skin to sunlight. As little as 5 minutes of sun exposure can cause flares and whealing on exposed skin sites, accompanied by severe itching. The wavelengths of radiation causing the eruption (i.e. the action spectrum) are in the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have a very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A delayed form of SU has also been reported, although this is extremely rare. Information on the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed to direct sunlight. The condition can be very distressing and severely impair the individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy, i.e. oral antihistamines, is only partially effective and may provide little worthwhile relief of symptoms. This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining the minimum urticarial dose before and after treatment. |
| NCT00979745 ↗ | Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP) | Completed | Clinuvel Pharmaceuticals Limited | Phase 3 | 2009-09-01 | Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is not yet available on the market. The purpose of this study is to look at whether afamelanotide can reduce the number and severity of EPP symptoms when patients are exposed to light. This study will also look at how the drug is tolerated when taken by people with EPP. The study will involve the use of an implant, which comes in the form of a small rod (approximately 2 cm x 0.15 cm) to be administered under the skin. The implant may contain the study drug afamelanotide or a placebo (inactive medication). Over 450 subjects have been treated with afamelanotide to date with no serious safety concerns identified. For this study, afamelanotide has been formulated as a controlled release depot injection (implant). This means that the afamelanotide will be released slowly into the body over a few days. Once inserted, the implant will remain in the body after afamelanotide has been released and will slowly dissolve. This study will help to provide more information about afamelanotide. This information will be used to determine the safety and efficacy (the ability of the drug to produce an effect) of this drug in EPP sufferers. Up to 70 people will participate in this study from study sites across Europe. |
| NCT01097044 ↗ | Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) | Completed | Clinuvel Pharmaceuticals Limited | Phase 2 | 2010-04-01 | This is a randomized placebo-controlled study to be conducted in two parallel study arms for a six month period (three doses). Approximately 10 eligible patients per center will be enrolled and will receive afamelanotide (16 mg implants) or placebo according to the following dosing regimen: - Group A will be administered afamelanotide implants on Days 0, 60 and 120 - Group B will be administered placebo implants on Days 0, 60 and 120 To determine eligibility for study inclusion, patients will undergo a screening evaluation 7 to 14 days prior to the administration of the first dose. The number and severity of phototoxic reactions will be determined Days 60, 120, and 180. Quality of life will be measured using the EPP specific questionnaire (EPP-QoL) every 60 days and the DLQI questionnaire every 7 days, beginning at Day 0 until Day 180. Participants will visit the clinic on Days 60, 120 and 180 for assessments of adverse events. |
| NCT01382589 ↗ | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo | Completed | Clinuvel Pharmaceuticals Limited | Phase 2 | 2011-09-01 | The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV). |
| NCT01430195 ↗ | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) | Completed | Clinuvel Pharmaceuticals Limited | Phase 1 | 2011-06-01 | The purpose of this study is to look at the efficacy of afamelanotide, when combined with narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo. Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to reducing frequency and doses of NB-UVB. |
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