97. 潰瘍性大腸炎 [臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
55 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000642-62-SE18/03/202025/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
462Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
2EUCTR2016-000642-62-FR10/03/202030/07/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
462Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
3EUCTR2016-000642-62-DE04/11/201918/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
4EUCTR2016-000642-62-HR30/08/201920/01/2020A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
462Phase 3Portugal;Belarus;United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
5EUCTR2016-000642-62-PT29/07/201916/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
462Phase 3Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;United States;Belarus;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Croatia;Germany;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-000642-62-GB26/07/201925/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
7EUCTR2016-000642-62-GR21/06/201925/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
8EUCTR2016-000642-62-IE18/06/201926/11/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
522Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
9EUCTR2016-000642-62-NL13/06/201911/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
462Phase 3Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
10EUCTR2016-000642-62-LT19/03/201915/11/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
462Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-000642-62-PL14/03/201912/06/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
462Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Croatia;Germany;Norway;Japan;Sweden
12EUCTR2016-000642-62-SK28/01/201928/01/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
13EUCTR2016-000642-62-ES17/01/201924/01/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative ColitisM14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
462 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
14EUCTR2016-000642-62-CZ14/01/201914/11/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
15EUCTR2016-000642-62-AT02/01/201930/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-000642-62-HU19/12/201808/01/2019 A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative ColitisM14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
462 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
17JPRN-JapicCTI-18413118/12/201828/09/2018A Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis [M14-675] Ulcerative ColitisIntervention name : ABT-494
INN of the intervention : upadacitinib
Dosage And administration of the intervention : Will be orally administered
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Will be orally administered
AbbVie GKNULLrecruiting1675BOTH45Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa, -
18EUCTR2016-000642-62-LV13/12/201815/10/2018 A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
462 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
19EUCTR2016-000642-62-FI13/11/201816/10/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
462Phase 3Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
20NCT03653026November 12, 201828/8/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis (UC)Drug: Upadacitinib (ABT-494);Drug: PlaceboAbbVieNULLActive, not recruiting16 Years75 YearsAll523Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Egypt;Romania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-000641-31-BE29/03/201831/10/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
22EUCTR2016-000674-38-HR21/08/201706/11/2017Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;Serbia;Belarus;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
23EUCTR2016-000674-38-IE19/06/201704/10/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
24EUCTR2016-000674-38-CZ06/04/201722/09/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
25EUCTR2016-000641-31-LT31/03/201711/10/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2016-000674-38-LT31/03/201725/10/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
27EUCTR2016-000641-31-CZ02/03/201729/09/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil
28EUCTR2016-000674-38-FI21/02/201726/09/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
950 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Germany;Norway;Japan;New Zealand;Sweden
29EUCTR2016-000641-31-FI07/02/201726/09/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
30NCT03006068January 31, 201720/12/2016A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative ColitisUlcerative Colitis (UC)Drug: Upadacitinib (ABT-494);Drug: PlaceboAbbVieNULLEnrolling by invitation16 Years75 YearsAll950Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Egypt;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2016-000674-38-SE30/01/201728/09/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
32EUCTR2016-000641-31-SE30/01/201729/09/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
33EUCTR2016-000674-38-PT09/01/201711/10/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;Belarus;Taiwan;Slovakia;Greece;Ukraine;Chile;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
34EUCTR2016-000641-31-PT09/01/201706/10/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Portugal;Belarus;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
35EUCTR2016-000674-38-BE06/01/201731/10/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
950 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Germany;Norway;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-000641-31-IE22/12/201604/10/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
37EUCTR2016-000674-38-GR21/12/201603/10/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
38EUCTR2016-000674-38-EE08/12/201604/10/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;Serbia;Belarus;United States;Saudi Arabia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden
39EUCTR2016-000641-31-EE08/12/201603/11/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden;Argentina;Belgium;Poland;Brazil;Portugal;Serbia;Belarus;United States;Saudi Arabia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada
40EUCTR2016-000641-31-GB07/12/201611/01/2017Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2016-000641-31-HU29/11/201628/09/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
42EUCTR2016-000674-38-GB25/11/201628/09/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
43EUCTR2016-000641-31-NL23/11/201608/08/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1055 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noBelarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
44EUCTR2016-000674-38-NL23/11/201622/08/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
950 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Germany;Norway;Japan;New Zealand;Sweden
45EUCTR2016-000674-38-AT23/11/201623/09/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Greece;Ukraine;Chile;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2016-000641-31-PL25/10/201630/09/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1055 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noBelarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
47EUCTR2016-000674-38-PL25/10/201627/09/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Germany;Norway;Japan;Sweden
48EUCTR2016-000641-31-AT17/10/201611/10/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
49NCT02819635September 26, 201628/6/2016A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis (UC)Drug: Placebo;Drug: Updacitinib (ABT-494)AbbVieNULLRecruiting16 Years75 YearsAll844Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Egypt;Romania
50EUCTR2016-000674-38-SK20/09/201626/07/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2016-000641-31-SK20/09/201626/07/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
52EUCTR2016-000674-38-DE28/09/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib - Direct compression-yellow
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib -Direct compression-yellow
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib -Direct compression-yellow
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib - Wet Granulation-Yellow
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib - Wet Granulation-Yellow
Product Code: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
950Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
53EUCTR2016-000674-38-NO01/11/2016Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
950Phase 3Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
54EUCTR2016-000641-31-NO07/11/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
1055Phase 2;Phase 3Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico
55EUCTR2016-000641-31-DE06/10/2016Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
1055Phase 2;Phase 3Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan