299. 嚢胞性線維症
[臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162

Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
20 trials found
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-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
4EUCTR2017-003723-29-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 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden
5EUCTR2017-003723-29-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-003723-29-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 2Romania;Bulgaria;Germany;Netherlands;Sweden;United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland
7EUCTR2017-003723-29-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
8EUCTR2017-003723-29-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
9EUCTR2017-003723-29-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
10EUCTR2017-003723-29-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-003723-29-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
12EUCTR2017-003723-29-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
13EUCTR2017-003723-29-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
14EUCTR2017-003723-29-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
15EUCTR2017-003723-29-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-003723-29-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
17EUCTR2020-001762-11-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
18EUCTR2020-001762-11-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
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