QR-313 Gel for Topical (Cutaneous) Administration ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
36表皮水疱症5

36. 表皮水疱症


臨床試験数 : 163 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
No.TrialIDDate_
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agemin
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PhaseCountries
1EUCTR2017-004806-17-DE
(EUCTR)
27/09/201808/02/2018Study to Evaluate QR-313 in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 geneA first in human, double-blind, randomized, intra-subject placebo-controlled, multiple dose study of QR-313 evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene - WINGS Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene
MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: QR-313 Gel for Topical (Cutaneous) Administration
Product Code: QR-313
INN or Proposed INN: unavailable
Wings Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
8 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Spain;Germany;United Kingdom
2EUCTR2017-004806-17-ES
(EUCTR)
06/09/201811/04/2018Study to Evaluate QR-313 in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 geneA first in human, double-blind, randomized, intra-subject placebo-controlled, multiple dose study of QR-313 evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene - WINGS Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene
MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: QR-313 Gel for Topical (Cutaneous) Administration
Product Code: QR-313
INN or Proposed INN: unavailable
ProQR TheraputicsNULLNot RecruitingFemale: yes
Male: yes
8Phase 1;Phase 2France;United States;Czech Republic;Canada;Spain;Austria;Germany;United Kingdom
3EUCTR2017-004806-17-GB
(EUCTR)
18/05/201824/01/2018Study to Evaluate QR-313 in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 geneA first in human, double-blind, randomized, intra-subject placebo-controlled, multiple dose study of QR-313 evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene - WINGS Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene
MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: QR-313 Gel for Topical (Cutaneous) Administration
Product Code: QR-313
INN or Proposed INN: unavailable
Wings Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
8 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Spain;Germany;United Kingdom
4EUCTR2017-004806-17-CZ
(EUCTR)
21/03/2018Study to Evaluate QR-313 in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 geneA first in human, double-blind, randomized, intra-subject placebo-controlled, multiple dose study of QR-313 evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene - WINGS Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene
MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: QR-313 Gel for Topical (Cutaneous) Administration
Product Code: QR-313
INN or Proposed INN: unavailable
Wings Therapeutics Inc.NULLNAFemale: yes
Male: yes
8Phase 1;Phase 2France;United States;Czech Republic;Spain;Germany;United Kingdom
5EUCTR2017-004806-17-FR
(EUCTR)
05/02/2018Study to Evaluate QR-313 in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 geneA first in human, double-blind, randomized, intra-subject placebo-controlled, multiple dose study of QR-313 evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene - WINGS Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene
MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: QR-313 Gel for Topical (Cutaneous) Administration
Product Code: QR-313
INN or Proposed INN: unavailable
ProQR TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
14Phase 1;Phase 2United States;France;Czech Republic;Canada;Spain;Austria;Germany;United Kingdom