18 completed, 4 unknown, 1 active not recruiting. 13 Phase 2, 6 Phase 3, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Completed 9, Unknown 4 |
| Phase 3 | 6 | Completed 5, Active not recruiting 1 |
| Phase 1 | 4 | Completed 4 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients Afamelanotide 16mg implant - Erythropoietic Protoporphyria | Phase 1 / Phase 2 | Completed | Clinuvel Europe Limited | 28 | 2024-03-07 | 2026-07-27 |
| A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo Afamelanotide and NB-UVB Light, NB-UVB Light - Vitiligo | Phase 3 | Active not recruiting | Clinuvel, Inc. | 200 | 2023-10-11 | 2025-07-08 |
| Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP) Afamelanotide 16 MG - Variegate Porphyria | Phase 2 | Completed | Clinuvel Pharmaceuticals Limited | 6 | 2023-03-28 | 2025-04-27 |
| A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face Afamelanotide - Vitiligo | Phase 2 | Unknown | Clinuvel, Inc. | 6 | 2022-10-11 | 2023-02-09 |
| A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V Afamelanotide - Xeroderma Pigmentosum | Phase 2 | Unknown | Clinuvel Europe Limited | 6 | 2022-03-28 | 2023-09-21 |
| DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers Afamelanotide - Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers | Phase 1 | Completed | Clinuvel (UK) Ltd. | 10 | 2022-01-19 | 2023-02-09 |
| A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP) Afamelanotide - Xeroderma Pigmentosum | Phase 2 | Unknown | Clinuvel Europe Limited | 6 | 2021-10-19 | 2023-06-18 |
| A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Afamelanotide - Arterial Ischemic Stroke | Phase 2 | Completed | Clinuvel Pharmaceuticals Limited | 6 | 2021-06-03 | 2023-04-11 |
| Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) Afamelanotide, Placebo - Vitiligo | Phase 2 | Completed | Clinuvel Pharmaceuticals Limited | 21 | 2014-06-06 | 2023-09-22 |
| Phase III Confirmatory Study in Erythropoietic Protoporphyria Afamelanotide, Placebo - Erythropoietic Protoporphyria | Phase 3 | Completed | Clinuvel Pharmaceuticals Limited | 93 | 2012-05-01 | 2019-09-19 |
| Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo Afamelanotide, NB-UVB - Vitiligo | Phase 2 | Completed | Clinuvel Pharmaceuticals Limited | 15 | 2011-09-01 | 2013-03-22 |
| A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) Afamelanotide - Erythropoietic Protoporphyria | Phase 3 | Completed | Clinuvel Pharmaceuticals Limited | 16 | 2011-07-11 | 2020-11-19 |
| Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) Afamelanotide, Narrow-Band UVB Light Treatment - Vitiligo | Phase 1 | Completed | Clinuvel Pharmaceuticals Limited | 56 | 2011-06-01 | 2013-03-22 |
| Afamelanotide in Patients Suffering With Acne Vulgaris Afamelanotide - Acne Vulgaris | Phase 2 | Completed | Clinuvel Pharmaceuticals Limited | 3 | 2010-08-24 | 2021-10-26 |
| Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) Afamelanotide, Placebo - Polymorphic Light Eruption | Phase 3 | Completed | Clinuvel Pharmaceuticals Limited | 31 | 2010-05-05 | 2021-03-19 |
| Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) Afamelanotide, Placebo - Erythropoietic Protoporphyria | Phase 2 | Completed | Clinuvel Pharmaceuticals Limited | 77 | 2010-04-01 | 2019-10-28 |
| Implant Pharmacokinetic and Pharmacodynamic Study Afamelanotide Group 1, Afamelanotide Group 2 - Healthy | Phase 1 | Completed | Clinuvel Pharmaceuticals Limited | 24 | 2009-09-01 | 2018-08-16 |
| Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP) Afamelanotide, Placebo - Erythropoietic Protoporphyria | Phase 3 | Completed | Clinuvel Pharmaceuticals Limited | 74 | 2009-09-01 | 2021-10-12 |
| Phase II Solar Urticaria (SU) Pilot Study afamelanotide - Solar Urticaria | Phase 2 | Completed | Clinuvel Pharmaceuticals Limited | 5 | 2008-12-01 | 2009-09-15 |
| Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium Afamelanotide, Placebo - Patients Undergoing Photodynamic Therapy Using Porfimer Sodium | Phase 2 | Completed | Clinuvel Pharmaceuticals Limited | 16 | 2008-08-05 | 2021-10-01 |
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Protoporphyria, Erythropoietic (6) · Vitiligo (5) · Xeroderma Pigmentosum (2) · Acne Vulgaris (1) · Carcinoma, Squamous Cell (1) · Ischemic Stroke (1) · Keratosis, Actinic (1) · Porphyria, Variegate (1) · Urticaria, Solar (1)
Clinuvel Pharmaceuticals Limited (17) · Clinuvel Europe Limited (3) · Clinuvel, Inc. (2) · Clinuvel (UK) Ltd. (1)
United States (6) · United Kingdom (5) · Australia (3) · Belgium (3) · France (3) · Germany (3) · Netherlands (3) · Austria (1) · Finland (1) · Ireland (1) · Italy (1) · Kenya (1) · Spain (1) · Sweden (1) · Switzerland (1)
Robert Desnick, MD (2) · Alex Anstey, MBBS, FRCP (1) · Chris Baker, MD (1) · Eric JG Sijbrands, MD, PhD (1) · Gillian M Murphy, MD PhD (1) · Giovanni Leone, MD (1) · Henry Lim, MD (1) · Herbert Hoenigsmann, MD (1) · Jean-Charles Deybach, MD. PhD (1) · Jorge Frank, MD, PhD (1) · Lesley E Rhodes, MD PhD (1) · Lesley Rhodes, M.D. (1) · Lesley Rhodes, MD (1)