96. クローン病
[臨床試験数:2,209,薬物数:1,276(DrugBank:240),標的遺伝子数:166,標的パスウェイ数:210

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
38 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04263831
(ClinicalTrials.gov)
December 1, 20207/2/2020LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASELOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASECrohn DiseaseDrug: Interleukin-2 (aldesleukin).Boston Children's HospitalNULLNot yet recruiting18 Years80 YearsAll30Phase 1;Phase 2United States
2EUCTR2018-004346-42-AT
(EUCTR)
18/06/202021/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany
3EUCTR2018-004346-42-BG
(EUCTR)
28/05/202008/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany
4EUCTR2018-004346-42-BE
(EUCTR)
15/04/202003/03/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
5EUCTR2018-004346-42-HU
(EUCTR)
25/03/202031/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-004346-42-CZ
(EUCTR)
24/03/202022/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
7EUCTR2018-004346-42-DE
(EUCTR)
10/12/201917/06/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
8EUCTR2018-004346-42-GB
(EUCTR)
10/09/201930/05/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden
9EUCTR2017-004997-32-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
10EUCTR2017-004997-32-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-004997-32-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
12EUCTR2017-004997-32-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
13EUCTR2015-000609-38-GB
(EUCTR)
17/07/201710/05/2018A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
Allergan LimitedNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovenia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
14EUCTR2015-000609-38-DE
(EUCTR)
10/05/201628/01/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
Allergan LimitedNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
15EUCTR2015-000609-38-BE
(EUCTR)
21/04/201625/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UKNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-000609-38-HU
(EUCTR)
04/04/201624/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
Allergan LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
17EUCTR2015-000609-38-BG
(EUCTR)
30/03/201615/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
Allergan LimitedNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
18EUCTR2015-000609-38-NL
(EUCTR)
24/03/201602/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - MEDI2070-LUX Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UKNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of
19EUCTR2015-000609-38-IT
(EUCTR)
04/03/201621/02/2018A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to SevereCrohn's Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - nd Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
Other descriptive name: anticorpo monoclonale anti-IL-23
MEDIMMUNE, LLCNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
20EUCTR2015-000609-38-ES
(EUCTR)
29/02/201608/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn?s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UKNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-000609-38-CZ
(EUCTR)
15/02/201629/01/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
MedImmune LimitedNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
22EUCTR2013-002902-29-NL
(EUCTR)
12/02/201525/02/2014Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: BI 655066 10 mg/ml
Product Code: BI 655066 10 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Product Name: BI 655066 90 mg/ml
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of
23EUCTR2013-002902-29-DE
(EUCTR)
22/12/201408/08/2014Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: Risankizumab 10 mg/ml
INN or Proposed INN: Risankizumab
Product Code: Risankizumab 90 mg/ml
INN or Proposed INN: Risankizumab
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
24EUCTR2013-002902-29-IE
(EUCTR)
03/02/201428/11/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer Ingelheim LimitedNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
25NCT02031276
(ClinicalTrials.gov)
February 201416/12/2013Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF TherapyCrohn DiseaseDrug: risankizumab IV;Drug: risankizumab SC;Drug: PlaceboAbbVieBoehringer IngelheimCompleted18 Years75 YearsAll121Phase 2Belgium;Canada;France;Germany;Ireland;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2013-002902-29-ES
(EUCTR)
09/01/201405/12/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of
27EUCTR2013-002902-29-BE
(EUCTR)
09/01/201420/09/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
Other descriptive name: BI 655066
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
28EUCTR2013-002902-29-GB
(EUCTR)
10/12/201326/11/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer Ingelheim LimitedNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
29EUCTR2012-004098-26-DE
(EUCTR)
17/04/201303/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy
30EUCTR2012-004098-26-FR
(EUCTR)
10/04/201325/09/2015Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2aUnited States;France;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT02676622
(ClinicalTrials.gov)
April 201321/4/2013Autologous Stem Cell Transplant for Refractory Crohn's DiseaseA Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's DiseaseCrohn's DiseaseDrug: mobilization of stem cells to prepare for Leukapheresis;Other: Leukapheresis- Collection of stem cells;Drug: Preparative regimen 4-6 weeks after Leukapheresis;Other: Stem Cell Transplant;Drug: Low-dose IL-2 administrationNationwide Children's HospitalNULLWithdrawn12 Years29 YearsAll0Phase 2NULL
32EUCTR2012-004098-26-IT
(EUCTR)
25/02/201311/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active,moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 inSubjects with Moderate to Severe Crohn's Disease Who Have Failed or AreIntolerant to Anti-tumor Necrosis Factor-alpha Therapy - MEDI 2070 Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
Other descriptive name: anticorpo monoclonale anti IL-23
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
120Phase 2Spain;Germany;Italy;France;United States;Hungary;Czech Republic;Canada
33EUCTR2012-004098-26-HU
(EUCTR)
11/02/201311/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Czech Republic;Hungary;Canada;Spain;Poland;Germany;Italy
34EUCTR2012-004098-26-CZ
(EUCTR)
08/02/201307/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy
35EUCTR2012-004098-26-ES
(EUCTR)
28/01/201322/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn´s disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn´s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn´s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
INN or Proposed INN: Not available
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT01266785
(ClinicalTrials.gov)
December 201023/12/2010Infliximab, Regulatory T Cells, IL2 and Crohn's DiseaseAnalysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's DiseaseCrohn's DiseaseDrug: InfliximabOregon Health and Science UniversityCentocor, Inc.Withdrawn18 Years70 YearsAll0N/AUnited States
37EUCTR2019-001866-14-GB
(EUCTR)
09/04/2020Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
AstraZeneca ABNULLNAFemale: yes
Male: yes
1000Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of
38EUCTR2018-004346-42-PL
(EUCTR)
01/08/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNAFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany