DUPILUMAB ( DrugBank: Dupilumab )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症2
98好酸球性消化管疾患15
160先天性魚鱗癬3
162類天疱瘡(後天性表皮水疱症を含む。)4

51. 全身性強皮症


臨床試験数 : 523 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04200755
(ClinicalTrials.gov)
May 19, 202010/12/2019Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized SclerodermaA Randomized, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Dupilumab in Localized SclerodermaLocalized SclerodermaDrug: Dupilumab 300Mg Solution for Injection;Other: PlaceboUniversity of CologneNULLRecruiting18 YearsN/AAll45Phase 2Germany
2EUCTR2019-002036-90-DE
(EUCTR)
02/12/201902/10/2019Study to test effectiveness and safety of the drug Dupilumab in patients with localized sclerodermaA randomized, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of subcutaneous Dupilumab in localized scleroderma - DupiMorph Localized scleroderma
MedDRA version: 21.1;Level: LLT;Classification code 10009206;Term: Circumscribed scleroderma;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10027979;Term: Morphea;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Dupilumab
Product Code: Dupilumab
INN or Proposed INN: Dupilumab
Other descriptive name: SAR231893
University of CologneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Germany

98. 好酸球性消化管疾患


臨床試験数 : 171 薬物数 : 184 - (DrugBank : 47) / 標的遺伝子数 : 42 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05247866
(ClinicalTrials.gov)
March 202221/12/2021Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic EsophagitisEfficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic EsophagitisEosinophilic EsophagitisDietary Supplement: EoE food introduction-1st;Dietary Supplement: E0E food introduction-2nd;Dietary Supplement: EoE Food introduction-3rd dose;Drug: DupilumabChildren's Hospital of PhiladelphiaRegeneron Pharmaceuticals;Genzyme, a Sanofi CompanyNot yet recruiting6 Years25 YearsAll30Phase 4United States
2NCT03678545
(ClinicalTrials.gov)
May 14, 20216/8/2018Dupilumab in Eosinophilic GastritisA Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti-IL4a) in Subjects With Eosinophilic GastritisEosinophilic Gastritis;Eosinophilic GastroenteritisDrug: Dupilumab (blinded);Drug: Placebo (blinded);Drug: Dupilumab (open-label)Children's Hospital Medical Center, CincinnatiRegeneron Pharmaceuticals;National Institutes of Health (NIH)Recruiting12 Years70 YearsAll40Phase 2United States
3NCT04776694
(ClinicalTrials.gov)
March 29, 202125/2/2021Compassionate Use of DupilumabBullous Pemphigoid;Eosinophilic Esophagitis (EoE);Pediatric Asthma;Pediatric and Adolescent Chronic Rhinosinusitis With Nasal Polyps (CRSwNP);Pediatric Atopic DermatitisDrug: DupilumabRegeneron PharmaceuticalsNULLAvailableNULL
4NCT04394351
(ClinicalTrials.gov)
September 1, 20207/5/2020Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic EsophagitisEosinophilic Esophagitis (EoE)Drug: Dupilumab;Drug: Matching PlaceboRegeneron PharmaceuticalsSanofiActive, not recruiting1 Year11 YearsAll102Phase 3United States;Canada
5EUCTR2018-000844-25-DE
(EUCTR)
21/10/201913/11/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
6EUCTR2018-000844-25-SE
(EUCTR)
09/10/201915/11/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
290Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
7EUCTR2018-000844-25-GB
(EUCTR)
12/07/201920/11/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 3United States;Portugal;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
8EUCTR2018-000844-25-PT
(EUCTR)
08/07/201926/12/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
425Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
9EUCTR2018-000844-25-NL
(EUCTR)
03/07/201911/12/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
10EUCTR2018-000844-25-BE
(EUCTR)
14/06/201914/03/2019A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 3Canada;United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;Sweden
11EUCTR2018-000844-25-ES
(EUCTR)
05/04/201917/05/2019A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
425Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
12EUCTR2018-000844-25-FR
(EUCTR)
05/03/201914/11/2018A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
425 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
13EUCTR2018-000844-25-IT
(EUCTR)
05/02/201928/03/2019A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) Eosinophilic Esophagitis (EoE)
MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
425Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
14NCT03633617
(ClinicalTrials.gov)
September 24, 201814/8/2018Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisDrug: Dupilumab;Drug: PlaceboRegeneron PharmaceuticalsSanofiActive, not recruiting12 YearsN/AAll321Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
15NCT02379052
(ClinicalTrials.gov)
May 12, 201527/2/2015Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients With Active Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Dupilumab;Drug: PlaceboRegeneron PharmaceuticalsSanofiCompleted18 Years65 YearsAll47Phase 2United States

160. 先天性魚鱗癬


臨床試験数 : 36 薬物数 : 72 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04996485
(ClinicalTrials.gov)
March 1, 202121/7/2021Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in ChildrenScientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in ChildrenCongenital IchthyosisDrug: Secukinumab Injection;Drug: Ustekinumab Injection;Drug: Dupilumab Injection;Other: Symptomatic therapyNational Medical Research Center for Children's Health, Russian FederationNULLRecruiting6 Months18 YearsAll50Phase 4Russian Federation
2NCT04244006
(ClinicalTrials.gov)
July 23, 202013/1/2020A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton SyndromeA Randomized Double-blinded Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton SyndromeNetherton SyndromeDrug: Dupilumab Prefilled Syringe;Other: Placebo Prefilled SyringeUniversity Hospital, ToulouseMedSharingRecruiting18 YearsN/AAll24Phase 2/Phase 3France
3EUCTR2019-001220-35-FR
(EUCTR)
08/10/201923/04/2019A pilot study of the efficacy and safety of dupilumab versus placebo in patients with Netherton syndromeA randomized double-blinded pilot study of the efficacy and safety of dupilumab versus placebo in patients with Netherton syndrome - NS-Dupi Netherton syndrome
MedDRA version: 20.0;Level: PT;Classification code 10062909;Term: Netherton's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Dupixent
Product Name: DUPILUMAB
Product Code: SAR231893
CHU de ToulouseNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 83 薬物数 : 128 - (DrugBank : 51) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04776694
(ClinicalTrials.gov)
March 29, 202125/2/2021Compassionate Use of DupilumabBullous Pemphigoid;Eosinophilic Esophagitis (EoE);Pediatric Asthma;Pediatric and Adolescent Chronic Rhinosinusitis With Nasal Polyps (CRSwNP);Pediatric Atopic DermatitisDrug: DupilumabRegeneron PharmaceuticalsNULLAvailableNULL
2NCT04206553
(ClinicalTrials.gov)
October 28, 202018/12/2019A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous PemphigoidA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous PemphigoidBullous PemphigoidDrug: dupilumab;Drug: Matching Placebo;Drug: Oral corticosteroids (OCS)Regeneron PharmaceuticalsSanofiRecruiting18 Years90 YearsAll98Phase 2/Phase 3United States;Australia;France;Germany;Japan
3EUCTR2019-003520-20-DE
(EUCTR)
15/10/202026/03/2020A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous PemphigoidA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous Pemphigoid - LIBERTY-BP ADEPT Bullous pemphigoid (BP)
MedDRA version: 20.0;Level: PT;Classification code 10034277;Term: Pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2;Phase 3United States;France;Australia;Japan;Germany
4EUCTR2019-003520-20-FR
(EUCTR)
19/05/202025/03/2020A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous PemphigoidA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous Pemphigoid - LIBERTY-BP ADEPT Bullous pemphigoid (BP)
MedDRA version: 20.0;Level: PT;Classification code 10034277;Term: Pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Dupixent
Product Name: dupilumab
INN or Proposed INN: dupilumab
Other descriptive name: DUPILUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2;Phase 3United States;France;Spain;Australia;Germany;Japan