Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
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ClinicalTrials.gov Identifier: NCT01714726 |
Recruitment Status :
Completed
First Posted : October 26, 2012
Results First Posted : March 6, 2019
Last Update Posted : May 26, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: MEDI2070 Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 121 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 1, 2013 |
Actual Primary Completion Date : | May 20, 2014 |
Actual Study Completion Date : | December 14, 2016 |

Arm | Intervention/treatment |
---|---|
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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714726

Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01714726 |
Other Study ID Numbers: |
D5170C00001 EudraCT number: 2012-004098-26 2012-004098-26 ( EudraCT Number ) |
First Posted: | October 26, 2012 Key Record Dates |
Results First Posted: | March 6, 2019 |
Last Update Posted: | May 26, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
MEDI2070 inflammatory bowel disease moderate to severe Crohn's disease |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |