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Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

Primary Purpose

Crohn's Disease

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Brazikumab IV Infusion

Brazikumab SC Injection

Placebo

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring MEDI2070, inflammatory bowel disease, moderate to severe Crohn's Disease, IL-23

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior to screening
Men or women age 18 - 80 years at the time of screening
Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) and endoscopic demonstration of inflammation
Stable dose of medications for Crohn's disease therapy
Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent
Effective contraception from screening, and for 36 weeks after the last dose of investigational product
No known history of active tuberculosis (TB) & negative assessment for TB/latent TB

Exclusion Criteria:

Severe underlying immunosuppression
Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization
Recent treatment with approved or investigational biologic therapy for Crohn's disease
Recent or planned live attenuated vaccine
History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the cervix with apparent cure ≥ 12 months before screening
Pregnancy/breast feeding
Drug abuse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Brazikumab High Dose

Brazikumab High-Medium Dose

Brazikumab Low-Medium Dose

Brazikumab Low Dose

Arm Description

Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.

Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.

Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.

Outcomes

Primary Outcome Measures

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8

CDAI remission was defined as a CDAI score of <150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Secondary Outcome Measures

Percentage of Participants With Loose/Liquid Stool Frequency Response

Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response

CDAI response was defined as a decrease from baseline in the CDAI score of ≥100. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Percentage of Participants With CDAI Clinical Remission

CDAI clinical remission was defined as a CDAI score of <150. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response

SES-CD response was defined as a decrease from baseline in SES-CD score of ≥ 50%. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.

Percentage of Participants With Loose/Liquid Stool Frequency Remission

Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Remission

SES-CD remission was defined as a Total SES-CD score of ≤4 and no subscore >2. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.

Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission

PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain (on an 11-point scale where 0=no pain to 10=worst imaginable pain). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2-remission was defined as PRO2 less than 8 points. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.

Percentage of Participants With PRO2 Response

PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. PRO2 response was defined as remission or response in one symptom (either abdominal pain or stool frequency) plus response in the other: a) abdominal pain remission: On an 11-point (0 to 10) pain scale: During 1 week, no daily score > 2, b) abdominal pain response: On an 11-point (0 to 10) pain scale: ≥ 30% reduction in weekly pain score from baseline, c) loose/liquid stool frequency remission: Counting stools identified as Type 6 or 7 on Bristol Stool Form Scale (BSFS), (The BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool), during 1 week, each daily loose/liquid stool count ≤ 3, d) loose/liquid stool frequency response: Counting stools identified as Type 6 or 7 on BSFS, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline.

Serum Interleukin (IL)-22 and Serum Lipocalin 2 (LCN2) Concentration as a Biomarker of Brazikumab's Efficacy

Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28

CDAI modified sustained clinical remission was defined as a CDAI score of <150 at both Weeks 8 and 28. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=mild to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

Serum Brazikumab Concentration

Number of Participants With Serum Anti-drug Antibodies for Brazikumab

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest and TEAEs Leading to Discontinuation

An AE is any untoward medical occurrence in a patient/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not related to the investigational product. A TEAE is any new AE or worsening of an existing condition after initiation of treatment. An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life threatening, a congenital anomaly/birth defect, or an important medical event. AE of special interest were infusion/injection-site reactions, hypersensitivity reactions, malignancies, cardiac events like myocardial infarction, stroke/cardiovascular death, ocular AE including cataracts.

Number of Participants With Clinically Significant Laboratory Values

Laboratory parameters included tests for hematology, serum chemistry and urinalysis. Laboratory values that were outside the reference range, considered clinically significant were reported.

Percentage of Participants With Abdominal Pain Response

Abdominal pain response is defined as a ≥ 30% reduction in weekly pain score from baseline on an 11-point (0 to 10) pain scale, where 0 = no pain and 10 = worst imaginable pain.

Percentage of Participants With Abdominal Pain Remission

Abdominal pain remission is defined as no daily score > 2 on an 11-point (0 to 10) pain scale during 1 week, where 0 = no pain and 10 = worst imaginable pain.

Full Information

NCT ID

NCT02574637

First Posted

September 24, 2015

Last Updated

May 6, 2021

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02574637

Brief Title

Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

Official Title

A 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated for business reasons; not due to safety or efficacy concerns.

Study Start Date

January 5, 2016 (Actual)

Primary Completion Date

July 28, 2017 (Actual)

Study Completion Date

January 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.

Detailed Description

This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled, Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week, Open-label Period and a post-treatment 28 week observational safety follow-up period designed to evaluate the short-term efficacy and the short- and long term safety of brazikumab in participants with moderate to severe, active Crohn's disease (CD) who have failed or are intolerant to anti-TNFα therapy as determined by the Investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

MEDI2070, inflammatory bowel disease, moderate to severe Crohn's Disease, IL-23

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Brazikumab High Dose

Arm Type

Experimental

Arm Description

Arm Title

Brazikumab High-Medium Dose

Arm Type

Experimental

Arm Description

Arm Title

Brazikumab Low-Medium Dose

Arm Type

Experimental

Arm Description

Arm Title

Brazikumab Low Dose

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Brazikumab IV Infusion

Other Intervention Name(s)

MEDI2070

Intervention Description

Brazikumab IV infusion as per protocol specified dosing schedule.

Intervention Type

Drug

Intervention Name(s)

Brazikumab SC Injection

Other Intervention Name(s)

MEDI2070

Intervention Description

Brazikumab IV infusion as per protocol specified dosing schedule.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.

Primary Outcome Measure Information:

Title

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8

Description

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Percentage of Participants With Loose/Liquid Stool Frequency Response

Description

Time Frame

Baseline, Weeks 8, 16 and 28

Title

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response

Description

Time Frame

Baseline, Weeks 8, 16 and 28

Title

Percentage of Participants With CDAI Clinical Remission

Description

Time Frame

Weeks 16 and 28

Title

Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response

Description

Time Frame

Baseline, Weeks 16 and 28

Title

Percentage of Participants With Loose/Liquid Stool Frequency Remission

Description

Time Frame

Baseline, Weeks 8, 16 and 28

Title

Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Remission

Description

Time Frame

Weeks 16 and 28

Title

Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission

Description

Time Frame

Weeks 8, 16 and 28

Title

Percentage of Participants With PRO2 Response

Description

Time Frame

Baseline, Weeks 8, 16 and 28

Title

Serum Interleukin (IL)-22 and Serum Lipocalin 2 (LCN2) Concentration as a Biomarker of Brazikumab's Efficacy

Time Frame

Weeks 16 and 28

Title

Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28

Description

Time Frame

Weeks 8 and 28

Title

Serum Brazikumab Concentration

Time Frame

Predose at Weeks 0, 1, 4, 8, 12, 16, 28; Postdose at Weeks 0 and 4

Title

Number of Participants With Serum Anti-drug Antibodies for Brazikumab

Time Frame

Predose at Weeks 0, 4, 12, 16, 28, 40 and 52

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest and TEAEs Leading to Discontinuation

Description

Time Frame

From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)

Title

Number of Participants With Clinically Significant Laboratory Values

Description

Laboratory parameters included tests for hematology, serum chemistry and urinalysis. Laboratory values that were outside the reference range, considered clinically significant were reported.

Time Frame

From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)

Title

Percentage of Participants With Abdominal Pain Response

Description

Abdominal pain response is defined as a ≥ 30% reduction in weekly pain score from baseline on an 11-point (0 to 10) pain scale, where 0 = no pain and 10 = worst imaginable pain.

Time Frame

Baseline; Weeks 8, 16 and 28

Title

Percentage of Participants With Abdominal Pain Remission

Description

Abdominal pain remission is defined as no daily score > 2 on an 11-point (0 to 10) pain scale during 1 week, where 0 = no pain and 10 = worst imaginable pain.

Time Frame

Weeks 8, 16 and 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior to screening Men or women age 18 - 80 years at the time of screening Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) and endoscopic demonstration of inflammation Stable dose of medications for Crohn's disease therapy Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent Effective contraception from screening, and for 36 weeks after the last dose of investigational product No known history of active tuberculosis (TB) & negative assessment for TB/latent TB Exclusion Criteria: Severe underlying immunosuppression Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization Recent treatment with approved or investigational biologic therapy for Crohn's disease Recent or planned live attenuated vaccine History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the cervix with apparent cure ≥ 12 months before screening Pregnancy/breast feeding Drug abuse

Facility Information:

Facility Name

Arizona Arthritis & Rheumatology Research, PLLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

South Denver Gastroenterology, PC

City

Lone Tree

State/Province

Colorado

ZIP/Postal Code

80124-5520

Country

United States

Facility Name

Research Site

City

Lone Tree

State/Province

Colorado

ZIP/Postal Code

80124

Country

United States

Facility Name

Clinical Research of West Florida - Corporate

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Borland-Groover Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Advanced Pharma CR, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

IMIC, Inc.

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

University of Chicago Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

NorthShore University HealthSystem

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Research Site

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Research Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Cotton-O'Neil Clinical Research Center, Digestive Health

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Research Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Graves Gilbert Clinic

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Research Site

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

University of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Clinical Trials of SW Louisiana, LLC

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Research Site

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Clinical Trials Management, LLC

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Research Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Research Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Research Site

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Revival Research Institute, LLC

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Mayo Clinic - Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Ehrhardt Clinical Research, LLC

City

Belton

State/Province

Missouri

ZIP/Postal Code

64012

Country

United States

Facility Name

Research Site

City

Belton

State/Province

Missouri

ZIP/Postal Code

64012

Country

United States

Facility Name

New York University Medical Center

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Premier Medical Group of the Hudson Valley, PC

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

Research Site

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28205

Country

United States

Facility Name

Clinical Inquest Center Ltd

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Donald Guthrie Foundation

City

Sayre

State/Province

Pennsylvania

ZIP/Postal Code

18840

Country

United States

Facility Name

Research Site

City

Sayre

State/Province

Pennsylvania

ZIP/Postal Code

18840

Country

United States

Facility Name

Erlanger Health System

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Gastroenterology Research of America

City

Houston

State/Province

Texas

ZIP/Postal Code

77098

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77098

Country

United States

Facility Name

Baylor Research Institute

City

Temple

State/Province

Texas

ZIP/Postal Code

76508-0001

Country

United States

Facility Name

Research Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Allegiance Research Specialists, LLC

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Research Site

City

Wauwatosa

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Princess Alexandra Hospital

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Research Site

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Imeldaziekenhuis

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Research Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

London Health Science Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

LHSC - Victoria Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Research Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Royal University Hospital

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

CHU de Toulouse - Hôpital Rangueil

City

Toulouse Cedex 09

State/Province

Haute Garonne

ZIP/Postal Code

31059

Country

France

Facility Name

CHU Rennes - Hôpital Pontchaillou

City

Rennes cedex 09

State/Province

Ille Et Vilaine

ZIP/Postal Code

35033

Country

France

Facility Name

CHU Saint Etienne - Hôpital Nord

City

Saint Etienne

State/Province

Loire

ZIP/Postal Code

42055

Country

France

Facility Name

Hôpital de Brabois Adultes

City

Vandoeuvre les Nancy

State/Province

Meurthe Et Moselle

ZIP/Postal Code

54511

Country

France

Facility Name

Research Site

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Research Site

City

Saint-Priez En Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

Research Site

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Research Site

City

Vandoeuvre-Les-Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Medizinische Hochschule Hannover

City

Marburg

State/Province

Hessen

ZIP/Postal Code

30625

Country

Germany

Facility Name

St. Johannes Hospital

City

Dortmund

State/Province

Nordrhein Westfalen

ZIP/Postal Code

44137

Country

Germany

Facility Name

Research Site

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Magyar Honvedseg Egeszsegugyi Kozpont

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

Semmelweis Egyetem

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Kaplan Medical Center

City

Rechovot

ZIP/Postal Code

7610001

Country

Israel

Facility Name

Research Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Istituto Clinico Humanitas

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Research Site

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Maastricht University Medical Center

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Research Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Erasmus Medisch Centrum

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Research Site

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

TSBIH "Territorial Clinical Hospital"

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

Pavlov First Saint Petersburg State Medical University

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Hospital Universitari Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Universitari de Bellvitge

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Research Site

City

L'Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

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Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

Crohn's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial