97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

  
23 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002135-19-FR
(EUCTR)
16/07/202102/04/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
2NCT03920254
(ClinicalTrials.gov)
July 23, 202028/3/2019TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) StudyA 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)Ulcerative Colitis (UC)Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose CTheravance BiopharmaNULLTerminated18 YearsN/AAll46Phase 2/Phase 3United States;Australia;Bulgaria;Canada;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Poland;Portugal;Romania;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine
3EUCTR2018-002135-19-IT
(EUCTR)
30/01/202017/06/2021A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: [TD-1473]
Product Name: TD-1473
Product Code: [TD-1473]
Product Name: TD-1473
Product Code: [TD-1473]
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
4EUCTR2018-002136-24-IT
(EUCTR)
10/01/202017/06/2021A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: [TD-1473]
Product Name: TD-1473
Product Code: [TD-1473]
Product Name: TD-1473
Product Code: [TD-1473]
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
880Phase 2;Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
5EUCTR2018-002135-19-BG
(EUCTR)
30/10/201911/07/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Japan;Germany;Bulgaria;Georgia;Romania;Croatia;Poland;Canada;Hungary;United Kingdom;Korea, Republic of;South Africa;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;Portugal;Serbia;United States
6EUCTR2018-002135-19-GR
(EUCTR)
13/09/201904/06/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
7EUCTR2018-002136-24-FR
(EUCTR)
10/09/201919/12/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
880Phase 2;Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
8EUCTR2018-002135-19-DE
(EUCTR)
26/08/201925/02/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
9EUCTR2018-002136-24-DE
(EUCTR)
25/06/201927/12/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
880Phase 2;Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
10EUCTR2018-002135-19-PL
(EUCTR)
19/06/201905/04/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
11EUCTR2018-002136-24-BG
(EUCTR)
12/06/201918/01/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
880Phase 2;Phase 3United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
12EUCTR2018-002135-19-ES
(EUCTR)
10/06/201912/04/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
13EUCTR2018-002135-19-PT
(EUCTR)
05/06/201915/03/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan
14EUCTR2018-002135-19-SK
(EUCTR)
28/05/201915/03/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
15EUCTR2018-002136-24-ES
(EUCTR)
23/05/201911/04/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
880Phase 2;Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
16EUCTR2018-002135-19-HU
(EUCTR)
11/04/201919/02/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study Moderately-to-severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
17EUCTR2018-002136-24-PL
(EUCTR)
04/04/201918/01/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
880Phase 2;Phase 3Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
18EUCTR2018-002136-24-GR
(EUCTR)
03/04/201918/02/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
880Phase 2;Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
19EUCTR2018-002136-24-PT
(EUCTR)
18/03/201902/01/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
880Phase 2;Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
20NCT03758443
(ClinicalTrials.gov)
March 11, 201919/11/2018Efficacy & Safety of TD-1473 in Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative ColitisUlcerative Colitis (UC)Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C;Drug: PlaceboTheravance BiopharmaNULLTerminated18 YearsN/AAll243Phase 2/Phase 3Canada;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Poland;Portugal;Romania;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United States;Bulgaria;Australia
21EUCTR2018-002136-24-SK
(EUCTR)
19/02/201928/12/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
880Phase 2;Phase 3United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
22EUCTR2018-002136-24-HU
(EUCTR)
18/02/201929/03/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative ColitisA Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
880Phase 2;Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
23NCT02818686
(ClinicalTrials.gov)
October 3, 201623/6/2016TD-1473 for Active Ulcerative Colitis (UC)A Phase 1b Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative ColitisUlcerative Colitis, Active Moderate;Ulcerative Colitis, Active SevereDrug: TD-1473;Drug: PlaceboTheravance BiopharmaNULLCompleted18 Years75 YearsAll40Phase 1United States;Georgia;Moldova, Republic of;Romania