Afamelanotide ( DrugBank: Afamelanotide )


2 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6
254ポルフィリン症11

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05370235
(ClinicalTrials.gov)
March 28, 202221/4/2022A Study to Evaluate the Safety and Efficacy of 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)Xeroderma PigmentosumDrug: AfamelanotideClinuvel Europe LimitedNULLRecruiting18 Years75 YearsAll6Phase 2Belgium;Spain
2EUCTR2021-001419-10-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
3NCT05159752
(ClinicalTrials.gov)
October 19, 20219/11/2021A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)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)Xeroderma PigmentosumDrug: AfamelanotideClinuvel Europe LimitedNULLRecruiting18 Years75 YearsAll6Phase 2Germany
4EUCTR2021-003642-20-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
5EUCTR2019-000597-34-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
6EUCTR2021-001419-10-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

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004164-60-NL
(EUCTR)
19/05/202221/02/2022Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin diseaseA 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: SCENESSECLINUVEL (UK) LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 2Netherlands;Switzerland
2NCT01605136
(ClinicalTrials.gov)
May 201222/5/2012Phase III Confirmatory Study in Erythropoietic ProtoporphyriaA Phase III, Multicentre, Double-Blind, Randomized, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)Erythropoietic ProtoporphyriaDrug: Afamelanotide;Drug: PlaceboClinuvel Pharmaceuticals LimitedNULLCompleted18 YearsN/AAll93Phase 3United States
3NCT04578496
(ClinicalTrials.gov)
July 11, 20115/10/2020A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)Erythropoietic ProtoporphyriaDrug: AfamelanotideClinuvel Pharmaceuticals LimitedNULLCompleted18 Years75 YearsAll16Phase 3NULL
4NCT01097044
(ClinicalTrials.gov)
April 201030/3/2010Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)A Phase II, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)Erythropoietic ProtoporphyriaDrug: Afamelanotide;Drug: PlaceboClinuvel Pharmaceuticals LimitedNULLCompleted18 YearsN/AAll77Phase 2United States
5EUCTR2009-011018-51-IE
(EUCTR)
09/03/201020/01/2010A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 Erythropoietic Protoporphyria (EPP).
MedDRA version: 12.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria
Product Name: afamelanotide
Product Code: CUV1647
INN or Proposed INN: Afamelanotide
Clinuvel Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 3Finland;United Kingdom;Netherlands;Ireland
6NCT00979745
(ClinicalTrials.gov)
September 200917/9/2009Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)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 Protoporphyria (EPP)Erythropoietic ProtoporphyriaDrug: Afamelanotide;Drug: PlaceboClinuvel Pharmaceuticals LimitedNULLCompleted18 Years70 YearsBoth70Phase 3Finland;France;Germany;Ireland;Netherlands;United Kingdom
7EUCTR2009-011018-51-FI
(EUCTR)
18/08/200920/04/2009A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 Erythropoietic Protoporphyria (EPP)
MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria
Product Name: afamelanotide
Product Code: CUV1647
Clinuvel Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 3Finland;United Kingdom;Netherlands;Ireland
8EUCTR2009-011018-51-NL
(EUCTR)
06/08/200903/04/2009A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 Erythropoietic Protoporphyria (EPP)
MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria
Product Name: afamelanotide
Product Code: CUV1647
Clinuvel Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 3Finland;United Kingdom;Netherlands;Ireland
9EUCTR2009-011018-51-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
10NCT04053270
(ClinicalTrials.gov)
May 20078/8/2019Multicentre Phase III Erythropoietic Protoporphyria StudyA Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutanenous Bioresorbable CUV1647 Implants in Patients With Erythropoietic Protoporphyria (EPP)Erythropoietic ProtoporphyriaDrug: Afamelanotide;Drug: PlaceboClinuvel Pharmaceuticals LimitedNULLCompleted18 Years70 YearsAll100Phase 3NULL
11EUCTR2007-000636-13-DE
(EUCTR)
12/11/2008A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP StudyA Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study Erythropoietic Protoporphyria (EPP)
MedDRA version: 12.0;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria
Product Name: Afamelanotide Implant
Product Code: CUV1647
INN or Proposed INN: afamelanotide
Other descriptive name: [Nle4,D-Phe7]-a-melanocyte stimulating hormone or NDP-a-MSH
Clinuvel Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United Kingdom;Germany;Netherlands;France;Italy;Sweden