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

May 7, 2021 updated by: AstraZeneca

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Research Site
    • Ontario
      • Guelph, Ontario, Canada, N1H 3R3
        • Research Site
      • Kingston, Ontario, Canada, K7L 5G2
        • Research Site
      • London, Ontario, Canada, N6A 5A5
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M5G 1X5
        • Research Site
      • Toronto, Ontario, Canada, M6H 3M1
        • Research Site
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Research Site
  • Czechia
      • Ceske Budejovice, Czechia, 370 01
        • Research Site
      • Hradec Kralove, Czechia, 500 12
        • Research Site
      • Litomerice, Czechia, 412 01
        • Research Site
      • Ostrava-Poruba, Czechia, 708 53
        • Research Site
      • Praha 10, Czechia, 100 34
        • Research Site
      • Praha 7, Czechia, 170 04
        • Research Site
  • France
      • Amiens Cedex 1, France, 88054
        • Research Site
      • Clichy, France, 92210
        • Research Site
      • Pessac, France, 33604
        • Research Site
      • Rouen, France, F-76031 CE
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
  • Germany
      • Hamburg, Germany, 20246
        • Research Site
      • Hamburg, Germany, 20249
        • Research Site
      • Munchen, Germany, 80331
        • Research Site
      • Potsdam, Germany, 14482
        • Research Site
  • Hungary
      • Budapest, Hungary, 1125
        • Research Site
      • Budapest, Hungary, 1062
        • Research Site
      • Budapest, Hungary, 1081
        • Research Site
      • Kaposvar, Hungary, 7400
        • Research Site
      • Szombathely, Hungary, 9700
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Research Site
      • Firenze, Italy, 50141
        • Research Site
      • Milano, Italy, 20100
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Roma, Italy, 133
        • Research Site
      • Roma, Italy, 196
        • Research Site
      • Rozzano, Italy, 20089
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Research Site
      • Bydgoszcz, Poland, 85-681
        • Research Site
      • Opole, Poland, 45-061
        • Research Site
      • Rzeszow, Poland, 35-301
        • Research Site
      • Sopot, Poland, 81-756
        • Research Site
      • Sosnowiec, Poland
        • Research Site
      • Warszawa, Poland, 02-507
        • Research Site
      • Wroclaw, Poland, 53-333
        • Research Site
  • Spain
      • Barcelona, Spain, 8035
        • Research Site
      • Barcelona, Spain, 8025
        • Research Site
      • Barcelona, Spain, 8916
        • Research Site
      • L'Hospitalet de Llobregat, Spain, 8907
        • Research Site
      • Sabadell(Barcelona), Spain, 8208
        • Research Site
      • Sevilla, Spain, 41014
        • Research Site
      • Sevilla, Spain, 41071
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
  • United States
    • California
      • Encinitas, California, United States, 92024
        • Research Site
      • Los Angeles, California, United States, 45242
        • Research Site
      • San Diego, California, United States, 92114
        • Research Site
      • Torrance, California, United States, 90505
        • Research Site
    • Colorado
      • Lakewood, Colorado, United States, 80215
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
      • Winter Park, Florida, United States, 32789
        • Research Site
    • Georgia
      • Macon, Georgia, United States, 31201
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Research Site
      • Hammond, Louisiana, United States, 70403
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
      • Chevy Chase, Maryland, United States, 20815
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Troy, Michigan, United States, 48098
        • Research Site
    • Missouri
      • Belton, Missouri, United States, 64012
        • Research Site
    • New York
      • New York, New York, United States, 10021
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Research Site
      • Charlotte, North Carolina, United States, 28207
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Lima, Ohio, United States, 45806
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
MEDI2070 iv infusion
Drug: MEDI2070
1 iv infusion on Week 0 and Week 4
Placebo Comparator: 2
placebo iv infusion
Drug: placebo
1 iv infusion on Week 0 and Week 4
Experimental: open-label
MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period
Drug: MEDI2070
1 iv infusion on Week 0 and Week 4

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8
Time Frame: 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.
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With CDAI-70 Point Improvement at Week 8
Time Frame: 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.
Week 8
Percentage of Participants With CDAI Response at Week 12
Time Frame: 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.
Week 12
Percentage of Participants With CDAI Remission at Week 8
Time Frame: 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.
Week 8
Percentage of Participants With CDAI-100 Point Improvement at Week 8
Time Frame: 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.
Week 8
Change From Baseline in CDAI Total Score at Week 8
Time Frame: 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.
Week 8
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period
Time Frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
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.
From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period
Time Frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
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.
From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
Number of Participants With TEAEs in Open-label Period
Time Frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
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.
From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
Number of Participants With TESAEs in Open-label Period
Time Frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
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.
From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period
Time Frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
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 to approximately 48 weeks). Subjects in the safety population were analysed for this end point.
From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period
Time Frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
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.
From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period
Time Frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
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). Subjects in the safety population were analysed for this end point.
From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period
Time Frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
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.
From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period
Time Frame: Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8
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).
Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8
Maximum Mean Serum Concentration of MEDI2070 in Open-label Period
Time Frame: Pre-dose on Weeks 12, 24, and 112
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).
Pre-dose on Weeks 12, 24, and 112
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period
Time Frame: Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)
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.
Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)
Number of Participants With ADA Positive to MEDI2070 in Open-label Period
Time Frame: Up to 28 week post last dose (approximately 140 weeks)
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.
Up to 28 week post last dose (approximately 140 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MedImmune Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5170C00001
  • EudraCT number: 2012-004098-26
  • 2012-004098-26 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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