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Uttr1147a    (DrugBank: -)

2 diseases
IDDisease name (Link within this page)Number of trials
96Crohn disease8
97Ulcerative colitis17

96. Crohn disease    [ 2,209 clinical trials,   1,276 drugs,   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways]
Searched query = "Crohn disease", "Terminal ileitis"
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.
8 / 2,209 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2017-004997-32-DE
(EUCTR)		25/06/201914/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		320Phase 2United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
2EUCTR2017-004997-32-HU
(EUCTR)		04/02/201904/04/2019A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
3EUCTR2017-004997-32-NL
(EUCTR)		30/01/201906/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc		Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes		320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
4NCT03650413
(ClinicalTrials.gov)		January 14, 201916/8/2018An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: UTTR1147AGenentech, Inc.NULLRecruiting18 Years80 YearsAll320Phase 2United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France
5EUCTR2017-004997-32-GB
(EUCTR)		04/01/201909/10/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		320Phase 2United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2017-004997-32-IE
(EUCTR)		14/12/201813/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
7EUCTR2017-004997-32-ES
(EUCTR)		10/12/201817/09/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Roche Farma, S.A por delegación de Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
8NCT02749630
(ClinicalTrials.gov)		April 11, 201612/4/2016A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Placebo;Drug: UTTR1147AGenentech, Inc.NULLCompleted18 Years80 YearsAll70Phase 1Germany;United Kingdom;Canada

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97. Ulcerative colitis    [ 2,269 clinical trials,   1,331 drugs,   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways]
Searched query = "Ulcerative colitis"
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.
17 / 2,269 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2017-004997-32-DE
(EUCTR)		25/06/201914/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		320Phase 2United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
2EUCTR2017-004997-32-HU
(EUCTR)		04/02/201904/04/2019A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
3EUCTR2017-004997-32-NL
(EUCTR)		30/01/201906/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc		Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes		320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
4NCT03650413
(ClinicalTrials.gov)		January 14, 201916/8/2018An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: UTTR1147AGenentech, Inc.NULLRecruiting18 Years80 YearsAll320Phase 2United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France
5EUCTR2017-004997-32-GB
(EUCTR)		04/01/201909/10/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		320Phase 2United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2017-004997-32-IE
(EUCTR)		14/12/201813/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
7EUCTR2017-002350-36-GB
(EUCTR)		10/12/201813/04/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		270Phase 2United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
8EUCTR2017-004997-32-ES
(EUCTR)		10/12/201817/09/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Roche Farma, S.A por delegación de Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
9NCT03558152
(ClinicalTrials.gov)		October 26, 20181/6/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: UTTR1147A;Drug: UTTR1147A Placebo;Drug: Vedolizumab;Drug: Vedolizumab PlaceboGenentech, Inc.NULLRecruiting18 Years80 YearsAll270Phase 2United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France
10EUCTR2017-002350-36-GR
(EUCTR)		03/10/201810/09/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		270Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11EUCTR2017-002350-36-DE
(EUCTR)		27/09/201813/04/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		270Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
12EUCTR2017-002350-36-IE
(EUCTR)		28/08/201816/04/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		270Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
13EUCTR2017-002350-36-NL
(EUCTR)		28/08/201824/04/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB		Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes		330Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
14EUCTR2017-002350-36-BG
(EUCTR)		22/08/201828/05/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		270Phase 2United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
15EUCTR2017-002350-36-HU
(EUCTR)		14/06/201819/04/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB		Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		270Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
16EUCTR2017-002350-36-ES
(EUCTR)		15/04/201806/06/2018A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB		Roche Farma, S.A por delegación de Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		330Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
17NCT02749630
(ClinicalTrials.gov)		April 11, 201612/4/2016A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Placebo;Drug: UTTR1147AGenentech, Inc.NULLCompleted18 Years80 YearsAll70Phase 1Germany;United Kingdom;Canada

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