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Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

Primary Purpose

Crohn's Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MEDI2070

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.
Men or women age 18 - 65 years at the time of screening.
Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.
No known history of active tuberculosis (TB).
Received at least one anti-TNFα agent for the treatment of CD and did not initially respond.

Exclusion Criteria:

Pregnant or breastfeeding women.
Presence of ileostomy and/or colostomy.
Short bowel syndrome.
Bowel perforation or obstruction.
History of cancer.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

open-label

Arm Description

MEDI2070 iv infusion

placebo iv infusion

MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period

Outcomes

Primary Outcome Measures

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

A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.

Secondary Outcome Measures

Percentage of Participants With CDAI-70 Point Improvement at Week 8

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.

Percentage of Participants With CDAI Response at Week 12

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.

Percentage of Participants With CDAI Remission at Week 8

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of < 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point.

Percentage of Participants With CDAI-100 Point Improvement at Week 8

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.

Change From Baseline in CDAI Total Score at Week 8

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period

An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.

Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period

Number of Participants With TEAEs in Open-label Period

An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.

Number of Participants With TESAEs in Open-label Period

Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period

The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment (up toapproximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.

Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period

Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period

The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.

Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period

Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070(either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (NA).

Maximum Mean Serum Concentration of MEDI2070 in Open-label Period

The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (NA).

Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period

Number of Participants With ADA Positive to MEDI2070 in Open-label Period

Full Information

NCT ID

NCT01714726

First Posted

October 24, 2012

Last Updated

May 7, 2021

Sponsor

AstraZeneca

Collaborators

MedImmune Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01714726

Brief Title

Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2013 (Actual)

Primary Completion Date

May 20, 2014 (Actual)

Study Completion Date

December 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

MedImmune Ltd

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

The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period

Detailed Description

This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled, treatment period followed by a 100-week, open label, treatment period to evaluate short-term efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the 12-week, double-blind, placebo-controlled, treatment period. At the completion of the double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070 (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28 weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after their last dose of IP for safety.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

MEDI2070 iv infusion

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo iv infusion

Arm Title

open-label

Arm Type

Experimental

Arm Description

MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period

Intervention Type

Drug

Intervention Name(s)

MEDI2070

Intervention Description

1 iv infusion on Week 0 and Week 4

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

1 iv infusion on Week 0 and Week 4

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Percentage of Participants With CDAI-70 Point Improvement at Week 8

Description

Time Frame

Week 8

Title

Percentage of Participants With CDAI Response at Week 12

Description

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.

Time Frame

Week 12

Title

Percentage of Participants With CDAI Remission at Week 8

Description

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of < 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point.

Time Frame

Week 8

Title

Percentage of Participants With CDAI-100 Point Improvement at Week 8

Description

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.

Time Frame

Week 8

Title

Change From Baseline in CDAI Total Score at Week 8

Description

The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point.

Time Frame

Week 8

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period

Description

Time Frame

From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)

Title

Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period

Description

Time Frame

From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)

Title

Number of Participants With TEAEs in Open-label Period

Description

Time Frame

From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)

Title

Number of Participants With TESAEs in Open-label Period

Description

Time Frame

From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)

Title

Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period

Description

Time Frame

From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)

Title

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period

Description

Time Frame

From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)

Title

Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period

Description

Time Frame

From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)

Title

Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period

Description

The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.

Time Frame

From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)

Title

Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period

Description

Time Frame

Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8

Title

Maximum Mean Serum Concentration of MEDI2070 in Open-label Period

Description

Time Frame

Pre-dose on Weeks 12, 24, and 112

Title

Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period

Description

Time Frame

Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)

Title

Number of Participants With ADA Positive to MEDI2070 in Open-label Period

Description

Time Frame

Up to 28 week post last dose (approximately 140 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening. Men or women age 18 - 65 years at the time of screening. Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1. No known history of active tuberculosis (TB). Received at least one anti-TNFα agent for the treatment of CD and did not initially respond. Exclusion Criteria: Pregnant or breastfeeding women. Presence of ileostomy and/or colostomy. Short bowel syndrome. Bowel perforation or obstruction. History of cancer.

Facility Information:

Facility Name

Research Site

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

45242

Country

United States

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Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92114

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United States

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Research Site

City

Torrance

State/Province

California

ZIP/Postal Code

90505

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United States

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Research Site

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80215

Country

United States

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Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

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Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Research Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

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Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

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United States

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Research Site

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Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

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United States

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Research Site

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Hammond

State/Province

Louisiana

ZIP/Postal Code

70403

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United States

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Research Site

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Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

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United States

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Research Site

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Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

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United States

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Research Site

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Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

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United States

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Troy

State/Province

Michigan

ZIP/Postal Code

48098

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United States

Facility Name

Research Site

City

Belton

State/Province

Missouri

ZIP/Postal Code

64012

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United States

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Research Site

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New York

State/Province

New York

ZIP/Postal Code

10021

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United States

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New York

State/Province

New York

ZIP/Postal Code

10029

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United States

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Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

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United States

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Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

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United States

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Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

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United States

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Research Site

City

Lima

State/Province

Ohio

ZIP/Postal Code

45806

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United States

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Research Site

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Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

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United States

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Research Site

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San Antonio

State/Province

Texas

ZIP/Postal Code

78229

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United States

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Research Site

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Seattle

State/Province

Washington

ZIP/Postal Code

98195

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United States

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Research Site

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Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2X8

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Canada

Facility Name

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City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2K5

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Canada

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Research Site

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St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

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Canada

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Research Site

City

Guelph

State/Province

Ontario

ZIP/Postal Code

N1H 3R3

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Canada

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Research Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5G2

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Canada

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City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

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Canada

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Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

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Canada

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Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

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Canada

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Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6H 3M1

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Canada

Facility Name

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City

Vaughan

State/Province

Ontario

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L4L 4Y7

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Canada

Facility Name

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Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

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Canada

Facility Name

Research Site

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Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czechia

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 12

Country

Czechia

Facility Name

Research Site

City

Litomerice

ZIP/Postal Code

412 01

Country

Czechia

Facility Name

Research Site

City

Ostrava-Poruba

ZIP/Postal Code

708 53

Country

Czechia

Facility Name

Research Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Research Site

City

Praha 7

ZIP/Postal Code

170 04

Country

Czechia

Facility Name

Research Site

City

Amiens Cedex 1

ZIP/Postal Code

88054

Country

France

Facility Name

Research Site

City

Clichy

ZIP/Postal Code

92210

Country

France

Facility Name

Research Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Research Site

City

Rouen

ZIP/Postal Code

F-76031 CE

Country

France

Facility Name

Research Site

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Research Site

City

Munchen

ZIP/Postal Code

80331

Country

Germany

Facility Name

Research Site

City

Potsdam

ZIP/Postal Code

14482

Country

Germany

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1081

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Research Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Research Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Research Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Research Site

City

Firenze

ZIP/Postal Code

50141

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20100

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

133

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

196

Country

Italy

Facility Name

Research Site

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-681

Country

Poland

Facility Name

Research Site

City

Opole

ZIP/Postal Code

45-061

Country

Poland

Facility Name

Research Site

City

Rzeszow

ZIP/Postal Code

35-301

Country

Poland

Facility Name

Research Site

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Facility Name

Research Site

City

Sosnowiec

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

53-333

Country

Poland

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

8025

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

8916

Country

Spain

Facility Name

Research Site

City

L'Hospitalet de Llobregat

ZIP/Postal Code

8907

Country

Spain

Facility Name

Research Site

City

Sabadell(Barcelona)

ZIP/Postal Code

8208

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

28390867

Citation

Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5.

Results Reference

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Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

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Evaluation of Efficacy and Safety of MEDI2070 in Patients 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

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