36. 表皮水疱症 Epidermolysis bullosa Clinical trials / Disease details
臨床試験数 : 160 / 薬物数 : 195 - (DrugBank : 47) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 124
| 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 | EUCTR2014-005679-96-LT (EUCTR) | 06/03/2017 | 09/02/2017 | An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa. | An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa | Epidermolysis Bullosa 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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands | ||
| 2 | EUCTR2014-002288-14-LT (EUCTR) | 07/12/2016 | 08/11/2016 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ ESSENCE Study | Epidermolysis Bullosa 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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Germany;Netherlands | ||
| 3 | EUCTR2014-005679-96-ES (EUCTR) | 14/11/2016 | 09/09/2016 | An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa. | An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa | Epidermolysis Bullosa MedDRA version: 19.0;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | France;United States;Poland;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2014-002288-14-ES (EUCTR) | 19/09/2016 | 05/08/2016 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa | Epidermolysis Bullosa MedDRA version: 19.0;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | France;United States;Belgium;Poland;Spain;Lithuania;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 5 | EUCTR2014-005679-96-NL (EUCTR) | 07/09/2015 | 02/03/2015 | An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa. | An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa | Epidermolysis Bullosa MedDRA version: 18.1;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | France;United States;Poland;Spain;Austria;Australia;Germany;Netherlands;Italy;United Kingdom | |||
| 6 | EUCTR2014-002288-14-PL (EUCTR) | 10/08/2015 | 11/06/2015 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study | Epidermolysis Bullosa 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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Germany;Netherlands | ||
| 7 | NCT02670330 (ClinicalTrials.gov) | June 9, 2015 | 28/7/2015 | Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa | An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisa™ (SD-101-6.0) in Patients With Epidermolysis Bullosa | Epidermolysis Bullosa | Drug: SD-101-6.0 cream | Scioderm, Inc. | Amicus Therapeutics | Terminated | 1 Month | N/A | All | 152 | Phase 3 | United States;Australia;Austria;France;Germany;Israel;Lithuania;Netherlands;Poland;Serbia;Spain;United Kingdom;Italy |
| 8 | EUCTR2014-005679-96-DE (EUCTR) | 22/05/2015 | 11/03/2015 | An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa. | An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa | Epidermolysis Bullosa 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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands | ||
| 9 | EUCTR2014-005679-96-GB (EUCTR) | 22/04/2015 | 04/03/2015 | An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa. | An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa | Epidermolysis Bullosa MedDRA version: 18.1;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | France;United States;Poland;Spain;Lithuania;Austria;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2014-002288-14-DE (EUCTR) | 31/03/2015 | 19/12/2014 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study | Epidermolysis Bullosa 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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Germany;Netherlands | ||
| 11 | EUCTR2014-005679-96-AT (EUCTR) | 16/03/2015 | 12/02/2015 | An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa. | An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa | Epidermolysis Bullosa 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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands | ||
| 12 | NCT02384460 (ClinicalTrials.gov) | March 11, 2015 | 13/2/2015 | ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa | Epidermolysis Bullosa | Drug: SD-101-6.0 cream;Drug: Placebo (SD-101-0.0) cream | Scioderm, Inc. | Amicus Therapeutics | Completed | 1 Month | N/A | All | 169 | Phase 3 | United States;Australia;Austria;France;Germany;Israel;Italy;Lithuania;Netherlands;Poland;Serbia;Spain;United Kingdom |
| 13 | EUCTR2014-002288-14-NL (EUCTR) | 23/12/2014 | 03/07/2014 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study | Epidermolysis Bullosa MedDRA version: 19.1;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Netherlands;Germany | ||
| 14 | EUCTR2014-002288-14-IT (EUCTR) | 18/12/2014 | 15/07/2014 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa | Epidermolysis Bullosa MedDRA version: 17.0;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | France;United States;Belgium;Spain;Poland;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 15 | EUCTR2014-002288-14-GB (EUCTR) | 26/09/2014 | 11/07/2014 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study | Epidermolysis Bullosa MedDRA version: 19.1;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Belgium;Poland;Romania;Australia;Germany;Netherlands | ||
| 16 | EUCTR2014-002288-14-AT (EUCTR) | 08/08/2014 | 02/07/2014 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ESSENCE Study | Epidermolysis Bullosa MedDRA version: 19.0;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands | ||
| 17 | NCT02090283 (ClinicalTrials.gov) | March 26, 2014 | 12/3/2014 | Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa | An Open Label Extension, Multi-Center, Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa | Epidermolysis Bullosa | Drug: SD-101 dermal cream (6%) | Scioderm, Inc. | Amicus Therapeutics;Food and Drug Administration (FDA) | Terminated | 6 Months | N/A | All | 42 | Phase 2 | United States |
| 18 | NCT02014376 (ClinicalTrials.gov) | January 6, 2014 | 12/12/2013 | Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa | A Phase 2b, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Effectiveness and Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa | Epidermolysis Bullosa | Drug: SD-101 dermal cream (3%);Drug: SD-101 Dermal Cream (6%);Drug: Vehicle (SD-101 0%) | Scioderm, Inc. | Amicus Therapeutics | Completed | 6 Months | N/A | All | 48 | Phase 2 | United States |
| 19 | EUCTR2014-005679-96-PL (EUCTR) | 11/12/2015 | An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa. | An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa | Epidermolysis Bullosa 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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm, INC, An Amicus Therapeutics Company | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Romania;Australia;Bulgaria;Germany;Netherlands | |||
| 20 | EUCTR2014-005679-96-IT (EUCTR) | 21/01/2021 | An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) creamused by Patients with Epidermolysis Bullosa. | An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of ZorblisaTM (SD-101-6.0) in Patients with Epidermolysis Bullosa - Long-term Safety study of Zorblisa in Patients with Epidermolysis Bullosa | Epidermolysis Bullosa 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] | INN or Proposed INN: ALLANTOINA | SCIODERM, INC | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Israel;Serbia;United States;Spain;Lithuania;Austria;Netherlands;Germany;Bulgaria;Australia;Romania;Poland;Belgium;France;Italy;United Kingdom | |||
| 21 | EUCTR2014-002288-14-BE (EUCTR) | 14/12/2016 | An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa | A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa - Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa/ ESSENCE Study | Epidermolysis Bullosa MedDRA version: 19.0;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: Zorblisa Product Code: SD-101 INN or Proposed INN: ALLANTOIN Other descriptive name: ALLANTOIN | Scioderm INC, An Amicus Therapeutics Company | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands |