SCENESSE ( DrugBank: - )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 159 | 色素性乾皮症 | 4 |
| 161 | 家族性良性慢性天疱瘡 | 1 |
| 254 | ポルフィリン症 | 2 |
159. 色素性乾皮症
臨床試験数 : 11 / 薬物数 : 17 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 15
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-001419-10-ES (EUCTR) | 31/01/2022 | 17/11/2021 | Study to evaluate the safety and the efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V | 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) - Phase IIa XPC and XPV Study | Patients with Xeroderma Pigmentosum C and V;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: Afamelanotide (16 mg implant) | CLINUVEL EUROPE LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Belgium;Spain | ||
| 2 | EUCTR2021-003642-20-DE (EUCTR) | 27/09/2021 | 09/07/2021 | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients withXeroderma Pigmentosum (XP) | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety andEfficacy of Subcutaneous Implants of Afamelanotide in Patients withXeroderma Pigmentosum (XP) - Phase IIa XP Study | xeroderma pigmentosum;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: SCENESSE INN or Proposed INN: Afamelanotide | CLINUVEL EUROPE LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Germany | ||
| 3 | EUCTR2019-000597-34-DE (EUCTR) | 01/06/2021 | 11/01/2021 | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients withXeroderma Pigmentosum (XP) | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety andEfficacy of Subcutaneous Implants of Afamelanotide in Patients withXeroderma Pigmentosum (XP) - Phase IIa XP Study | xeroderma pigmentosum;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: SCENESSE INN or Proposed INN: AFAMELANOTIDE | CLINUVEL EUROPE LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Germany | ||
| 4 | EUCTR2021-001419-10-BE (EUCTR) | 16/11/2021 | Study to evaluate the safety and efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V | 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) - Phase IIa XPC and XPV Study | Patients with Xeroderma Pigmentosum C and V;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: Afamelanotide (16 mg implant) | CLINUVEL EUROPE LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Spain;Belgium |
161. 家族性良性慢性天疱瘡
臨床試験数 : 5 / 薬物数 : 9 - (DrugBank : 4) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 24
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2013-004562-33-IT (EUCTR) | 17/12/2013 | 18/11/2013 | PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTS | PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTS | SYMPTOMATIC HHD PATIENTS MedDRA version: 16.1;Level: LLT;Classification code 10019029;Term: Hailey-Hailey disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: SCENESSE | ISTITUTI FISIOTERAPICI OSPITALIERI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Italy |
254. ポルフィリン症
臨床試験数 : 72 / 薬物数 : 53 - (DrugBank : 16) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 35
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-004164-60-NL (EUCTR) | 19/05/2022 | 21/02/2022 | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease | 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. - Phase IIa VP Study | Variegate Porphyria (VP)-related skin disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SCENESSE | CLINUVEL (UK) LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Netherlands;Switzerland | ||
| 2 | EUCTR2009-011018-51-GB (EUCTR) | 15/06/2009 | 27/04/2009 | A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension Study | A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 13.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Afamelanotide Product Code: CUV1647 INN or Proposed INN: afamelanotide Other descriptive name: Trade Name: SCENESSE | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland |