BT-11 ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
96Crohn disease10
97Ulcerative colitis6

96. Crohn disease


Clinical trials : 2,400 Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000824-17-SK
(EUCTR)
25/11/202129/07/2021A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease Patients with Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: BT-11
Other descriptive name: BT-11
Landos Biopharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Turkey;North Macedonia;Poland;Croatia;Albania;Georgia;Bulgaria;Bosnia and Herzegovina
2NCT05057273
(ClinicalTrials.gov)
November 202116/8/2021Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe DiseaseA Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe DiseaseCrohn's DiseaseDrug: BT-11 (Omilancor);Biological: adalimumabLandos Biopharma Inc.NULLNot yet recruiting18 Years75 YearsAll40Phase 2NULL
3EUCTR2019-000824-17-HR
(EUCTR)
28/07/202121/10/2021A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease Patients with Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: BT-11
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Belarus;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Austria;North Macedonia;Poland;Croatia;Albania;Georgia;Bulgaria;Netherlands;Moldova, Republic of;Bosnia and Herzegovina
4EUCTR2019-000824-17-BG
(EUCTR)
26/05/202110/05/2021A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease Patients with Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: BT-11
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Turkey;North Macedonia;Poland;Croatia;Bulgaria;Albania;Georgia;Bosnia and Herzegovina
5NCT03870334
(ClinicalTrials.gov)
May 5, 20218/3/2019Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's DiseaseA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: BT-11 1,000 mg;Drug: PlaceboLandos Biopharma Inc.NULLRecruiting18 Years75 YearsAll150Phase 2United States;Bulgaria;Poland
6EUCTR2018-005086-39-BG
(EUCTR)
27/10/202025/06/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
7EUCTR2018-005086-39-HR
(EUCTR)
16/12/201917/01/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
8EUCTR2018-005086-39-HU
(EUCTR)
28/10/201908/04/2019A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: to be requested
Product Code: BT-11
INN or Proposed INN: to be requested
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
9EUCTR2018-005086-39-PL
(EUCTR)
07/10/201906/05/2019A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
10NCT03860571
(ClinicalTrials.gov)
July 6, 20183/2/2019Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersA Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersUlcerative Colitis;Crohn DiseaseDrug: BT-11 Placebo;Drug: BT-11 ActiveLandos Biopharma Inc.NULLCompleted18 Years65 YearsAll70Phase 1United States

97. Ulcerative colitis


Clinical trials : 2,527 Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-005086-39-BG
(EUCTR)
27/10/202025/06/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
2EUCTR2018-005086-39-HR
(EUCTR)
16/12/201917/01/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
3EUCTR2018-005086-39-HU
(EUCTR)
28/10/201908/04/2019A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: to be requested
Product Code: BT-11
INN or Proposed INN: to be requested
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
4EUCTR2018-005086-39-PL
(EUCTR)
07/10/201906/05/2019A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
5NCT03861143
(ClinicalTrials.gov)
August 14, 201927/2/2019Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: PlaceboLandos Biopharma Inc.NULLCompleted18 Years65 YearsAll198Phase 2United States;Bosnia and Herzegovina;Croatia;Poland;Ukraine;Belarus;Georgia;Hungary;Moldova, Republic of;Russian Federation;Serbia
6NCT03860571
(ClinicalTrials.gov)
July 6, 20183/2/2019Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersA Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersUlcerative Colitis;Crohn DiseaseDrug: BT-11 Placebo;Drug: BT-11 ActiveLandos Biopharma Inc.NULLCompleted18 Years65 YearsAll70Phase 1United States