Ajulemic acid ( DrugBank: Ajulemic acid )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
50皮膚筋炎/多発性筋炎12
51全身性強皮症6
299嚢胞性線維症21

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-001762-11-GB
(EUCTR)
17/09/202023/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
2EUCTR2020-001762-11-HU
(EUCTR)
26/08/202002/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
3EUCTR2018-003273-10-DE
(EUCTR)
06/11/201911/12/2018A study of safety and efficacy of lenabasum in dermatomyositis patientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects Dermatomyositis (DM)
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Russian Federation;United States;Greece;Austria;Netherlands;Sweden;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Serbia;Romania;Hungary;Japan;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Belgium;Italy;Israel;Australia;Germany
4EUCTR2018-003273-10-SE
(EUCTR)
30/09/201918/03/2019A study of safety and efficacy of lenabasum in dermatomyositis patientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects Dermatomyositis (DM)
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Russian Federation;United States;Greece;Sweden;Austria;Netherlands;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Serbia;Romania;Hungary;Japan;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Belgium;Italy;Israel;Australia;Germany
5EUCTR2018-003273-10-CZ
(EUCTR)
27/05/201906/02/2019A study of safety and efficacy of lenabasum in dermatomyositis patientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects Dermatomyositis (DM)
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Serbia;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
6EUCTR2018-003273-10-GB
(EUCTR)
21/05/201920/11/2018A study of safety and efficacy of lenabasum in dermatomyositis patientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects Dermatomyositis (DM)
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
7EUCTR2018-003273-10-ES
(EUCTR)
16/05/201911/04/2019A study of safety and efficacy of lenabasum in dermatomyositis patientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects Dermatomyositis (DM)
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Switzerland;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
8EUCTR2018-003273-10-BG
(EUCTR)
13/05/201918/03/2019A study of safety and efficacy of lenabasum in dermatomyositis patientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects Dermatomyositis (DM)
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;Germany;Japan;Korea, Republic of;Sweden
9EUCTR2018-003273-10-HU
(EUCTR)
05/04/201906/02/2019A study of safety and efficacy of lenabasum in dermatomyositis patientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects Dermatomyositis (DM)
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Japan;Korea, Republic of;Sweden;United States;Serbia;Spain;United Kingdom;Switzerland;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria
10EUCTR2020-001762-11-SE
(EUCTR)
17/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
11EUCTR2020-001762-11-DE
(EUCTR)
17/09/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
12EUCTR2020-001762-11-AT
(EUCTR)
10/08/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-000372-29-PL
(EUCTR)
28/09/201802/07/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
2EUCTR2017-000372-29-IT
(EUCTR)
25/09/201827/01/2021Clinical Trial to evaluate efficacy and eafety of Lenabasum in for the diffuse dutaneous systemic sclerosis, a disease of the immune system attacking the connective tissue under the skin and around internal organs and blood vessels causing scarring and thickening of the tissue in these areas.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum 5mg Powder in Capsule
Product Code: [JBT-101]
INN or Proposed INN: lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum 20 mg Powder in Capsule
Product Code: [JBT-101]
Other descriptive name: resunab, ajulemic acid, anabasum
CORBUS PHARMACEUTICALS, INCNULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
3EUCTR2017-000372-29-NL
(EUCTR)
21/06/201824/01/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Netherlands;Germany;Japan;Korea, Republic of
4EUCTR2017-000372-29-ES
(EUCTR)
25/04/201802/02/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum 5 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum 20 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of;Sweden
5EUCTR2017-000372-29-GB
(EUCTR)
20/03/201807/12/2017A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
354 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
6EUCTR2017-000372-29-DE
(EUCTR)
07/03/201813/12/2017A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-001762-11-GB
(EUCTR)
17/09/202023/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
2EUCTR2020-001762-11-HU
(EUCTR)
26/08/202002/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
3EUCTR2017-003723-29-RO
(EUCTR)
18/06/201924/05/2022A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
4EUCTR2017-003723-29-PL
(EUCTR)
09/05/201907/11/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
5EUCTR2017-003723-29-NL
(EUCTR)
25/02/201920/06/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
6EUCTR2017-003723-29-CZ
(EUCTR)
27/11/201809/07/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
7EUCTR2017-003723-29-DE
(EUCTR)
19/11/201814/02/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
8EUCTR2017-003723-29-PT
(EUCTR)
19/11/201821/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden
9EUCTR2017-003723-29-GR
(EUCTR)
15/10/201808/08/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
10EUCTR2017-003723-29-BG
(EUCTR)
21/09/201808/05/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
11EUCTR2017-003723-29-BE
(EUCTR)
27/06/201829/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Romania;Bulgaria;Germany;Netherlands;Sweden
12EUCTR2017-003723-29-SE
(EUCTR)
07/06/201801/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
13EUCTR2017-003723-29-ES
(EUCTR)
21/05/201809/04/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
14EUCTR2017-003723-29-AT
(EUCTR)
17/05/201828/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
15EUCTR2017-003723-29-GB
(EUCTR)
11/05/201805/02/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
16EUCTR2017-003723-29-SK
(EUCTR)
26/04/201823/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
17EUCTR2017-003723-29-HU
(EUCTR)
16/04/201827/02/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
18EUCTR2020-001762-11-DE
(EUCTR)
17/09/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
19EUCTR2017-003723-29-FR
(EUCTR)
14/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden
20EUCTR2020-001762-11-SE
(EUCTR)
17/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
21EUCTR2020-001762-11-AT
(EUCTR)
10/08/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden