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1

159. 色素性乾皮症


臨床試験数 : 10 薬物数 : 18 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 15
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001419-10-ES
(EUCTR)
31/01/202217/11/2021Study to evaluate the safety and the efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and VA 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 LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 2Belgium;Spain
2EUCTR2021-003642-20-DE
(EUCTR)
27/09/202109/07/2021Study 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 LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 2Germany
3EUCTR2019-000597-34-DE
(EUCTR)
01/06/202111/01/2021Study 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 LIMITEDNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Germany
4EUCTR2021-001419-10-BE
(EUCTR)
16/11/2021Study to evaluate the safety and efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and VA 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 LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 2Spain;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-004562-33-IT
(EUCTR)
17/12/201318/11/2013PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTSPHASE 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 OSPITALIERINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2Italy

254. ポルフィリン症


臨床試験数 : 70 薬物数 : 54 - (DrugBank : 19) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 35
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-011018-51-GB
(EUCTR)
15/06/200927/04/2009A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension StudyA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
15Phase 3Finland;United Kingdom;Netherlands;Ireland