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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01714726
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: MEDI2070
Drug: placebo
Enrollment 121
Recruitment Details  
Pre-assignment Details Out of 174 screened subjects, 53 were considered screen failures. A total of 121 subjects were randomized, of which 2 did not receive study drug. Those 2 subjects were not included in the mITT population; therefore, those subjects are not counted in the participant flow.
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4. Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4. Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Period Title: Double-Blinded Induction Period
Started 60 59 0 0
Completed 52 52 0 0
Not Completed 8 7 0 0
Reason Not Completed
Subject not in open label period             3             1             0             0
Adverse Event             0             1             0             0
Withdrawal by Subject             5             3             0             0
Lost to Follow-up             0             2             0             0
Period Title: Open-Label Period
Started 0 0 52 52
Completed 0 0 33 24
Not Completed 0 0 19 28
Reason Not Completed
Other             0             0             1             3
Adverse Event             0             0             1             0
Withdrawal by Subject             0             0             9             19
Developed specific withdrawal criteria             0             0             5             2
Lost to Follow-up             0             0             3             4
Arm/Group Title Placebo Experimental: MEDI2070 700mg Total
Hide Arm/Group Description Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4. Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4. Total of all reporting groups
Overall Number of Baseline Participants 60 59 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 59 participants 119 participants
38.1  (10.7) 34.8  (11.1) 36.45  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 119 participants
Female
37
  61.7%
37
  62.7%
74
  62.2%
Male
23
  38.3%
22
  37.3%
45
  37.8%
1.Primary Outcome
Title Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Number
Unit of Measure: Percentage of Participants
26.7 49.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Experimental: MEDI2070 700mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.01
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 22.5
Confidence Interval (2-Sided) 90%
8.3 to 36.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With CDAI Remission at Week 8
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Number
Unit of Measure: Percentage of Participants
15 27.1
3.Secondary Outcome
Title Percentage of Participants With CDAI-100 Point Improvement at Week 8
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Number
Unit of Measure: Percentage of Participants
25.0 45.8
4.Secondary Outcome
Title Percentage of Participants With CDAI-70 Point Improvement at Week 8
Hide 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 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Number
Unit of Measure: Percentage of Participants
46.7 52.5
5.Secondary Outcome
Title Percentage of Participants With CDAI Response at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Number
Unit of Measure: Percentage of Participants
28.3 37.3
6.Secondary Outcome
Title Change From Baseline in CDAI Total Score at Week 8
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-62.7  (13.5) -99.0  (15.0)
7.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period
Hide Description 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.
Time Frame From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
41
  68.3%
40
  67.8%
8.Secondary Outcome
Title Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period
Hide Description 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.
Time Frame From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
5
   8.3%
5
   8.5%
9.Secondary Outcome
Title Number of Participants With TEAEs in Open-label Period
Hide Description 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.
Time Frame From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the double-blind portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 0 0 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
44
  84.6%
43
  82.7%
10.Secondary Outcome
Title Number of Participants With TESAEs in Open-label Period
Hide Description 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.
Time Frame From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the double-blind portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 0 0 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
8
  15.4%
12
  23.1%
11.Secondary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period
Hide 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 (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point.
Time Frame From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Anaemia
2
   3.3%
1
   1.7%
Leukopenia
0
   0.0%
1
   1.7%
Neutropenia
0
   0.0%
1
   1.7%
Urine analysis Abnormal
1
   1.7%
0
   0.0%
Urine Abnormality
0
   0.0%
1
   1.7%
Urine bilirubin increased
0
   0.0%
1
   1.7%
Proteinuria
0
   0.0%
1
   1.7%
12.Secondary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period
Hide 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 (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.
Time Frame From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the double-blind portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 0 0 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
Anaemia
5
   9.6%
5
   9.6%
Lymphocyte
0
   0.0%
1
   1.9%
Lymphopenia
0
   0.0%
1
   1.9%
Neutrophil count increased
0
   0.0%
1
   1.9%
Platelet count increased
0
   0.0%
1
   1.9%
Red cell distribution width increased
0
   0.0%
1
   1.9%
White blood cell count decreased
0
   0.0%
1
   1.9%
Chromaturia
0
   0.0%
1
   1.9%
Blood uric acid increased
1
   1.9%
0
   0.0%
Hypokalaemia
1
   1.9%
1
   1.9%
Hepatic enzyme increased
0
   0.0%
1
   1.9%
Hyperlipidemia
1
   1.9%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period
Hide 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 48 weeks). Subjects in the safety population were analysed for this end point.
Time Frame From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the double-blind portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
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Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 0 0 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period
Hide Description 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).
Time Frame Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8
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Hide Analysis Population Description
Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the open-label portion of the trial.
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Mean (Standard Deviation)
Unit of Measure: mcg/ML
Week 0 Post-dose (60, 58) Number Analyzed 60 participants 58 participants 0 participants 0 participants
NA [1]   (NA) 186  (83.8)
Week 4 Pre-dose (54, 53) Number Analyzed 54 participants 53 participants 0 participants 0 participants
NA [1]   (NA) 37.4  (52.3)
Week 4 Post-dose (52, 51) Number Analyzed 52 participants 51 participants 0 participants 0 participants
NA [1]   (NA) 209  (68.9)
Week 8 Pre-dose (55, 51) Number Analyzed 55 participants 51 participants 0 participants 0 participants
NA [1]   (NA) 39.2  (18.4)
[1]
Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frame
16.Secondary Outcome
Title Maximum Mean Serum Concentration of MEDI2070 in Open-label Period
Hide Description 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).
Time Frame Pre-dose on Weeks 12, 24, and 112
Hide Outcome Measure Data
Hide Analysis Population Description
Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the double-blind portion of the trial.
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 0 0 52 52
Mean (Standard Deviation)
Unit of Measure: mcg/ML
Week 12 Pre-dose (51, 52) Number Analyzed 0 participants 0 participants 51 participants 52 participants
NA [1]   (NA) 16.7  (11.8)
Week 24 Pre-dose (48, 43) Number Analyzed 0 participants 0 participants 48 participants 43 participants
14.5  (7.0) 15.1  (6.38)
Week 112 Pre-dose (24, 20) Number Analyzed 0 participants 0 participants 24 participants 20 participants
18.3  (7.73) 22.4  (7.97)
[1]
Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames
17.Secondary Outcome
Title Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period
Hide Description 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.
Time Frame Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the open-label portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 60 59 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.7%
18.Secondary Outcome
Title Number of Participants With ADA Positive to MEDI2070 in Open-label Period
Hide Description 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.
Time Frame Up to 28 week post last dose (approximately 140 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Value of 0 represents the double-blind portion of the trial
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description:
Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.
Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.
Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.
Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
Overall Number of Participants Analyzed 0 0 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.9%
1
   1.9%
Time Frame From study drug administration (Day 1) to 36 weeks post last dose (approximately 148 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Hide Arm/Group Description Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4. Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4. Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period. Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.
All-Cause Mortality
Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/60 (8.33%)      5/59 (8.47%)      8/52 (15.38%)      12/52 (23.08%)    
Blood and lymphatic system disorders         
Anemia  1  1/60 (1.67%)  1 0/59 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Lymphopenia  1  0/60 (0.00%)  0 0/59 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Gastrointestinal disorders         
Crohn's disease  1  2/60 (3.33%)  2 2/59 (3.39%)  2 1/52 (1.92%)  1 6/52 (11.54%)  6
Diarrhoea  1  1/60 (1.67%)  1 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Gastrointestinal haemorrhage  1  1/60 (1.67%)  1 0/59 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Large intestine perforation  1  0/60 (0.00%)  0 1/59 (1.69%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0
Abdominal pain  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Anal fistula  1  0/60 (0.00%)  0 0/59 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
General disorders         
Pyrexia  1  0/60 (0.00%)  0 1/59 (1.69%)  1 1/52 (1.92%)  1 0/52 (0.00%)  0
Adverse drug reaction  1  0/60 (0.00%)  0 0/59 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Infections and infestations         
Abdominal abscess  1  1/60 (1.67%)  1 0/59 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Cellulitis  1  0/60 (0.00%)  0 1/59 (1.69%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0
Pelvic abscess  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Pyelonephritis  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Anal abscess  1  0/60 (0.00%)  0 0/59 (0.00%)  0 0/52 (0.00%)  0 12/52 (23.08%)  12
Subcutaneous abscess  1  0/60 (0.00%)  0 0/59 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Peritonitis  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Injury, poisoning and procedural complications         
Intestinal anastomosis complication  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Accidental exposure to product  1  0/60 (0.00%)  0 0/59 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Metabolism and nutrition disorders         
Dehydration  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Hypokalaemia  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/60 (0.00%)  0 0/59 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Nervous system disorders         
Seizure  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  0/60 (0.00%)  0 0/59 (0.00%)  0 1/52 (1.92%)  1 1/52 (1.92%)  1
Vascular disorders         
Shock  1  0/60 (0.00%)  0 0/59 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Experimental: MEDI2070 700mg Placebo/MEDI2070 210mg MEDI2070 700mg/MEDI2070 210mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/60 (63.33%)      38/59 (64.41%)      43/52 (82.69%)      42/52 (80.77%)    
Blood and lymphatic system disorders         
Anaemia  1  1/60 (1.67%)  1 1/59 (1.69%)  1 5/52 (9.62%)  5 4/52 (7.69%)  4
Gastrointestinal disorders         
Abdominal pain  1  6/60 (10.00%)  6 6/59 (10.17%)  6 9/52 (17.31%)  9 10/52 (19.23%)  10
Crohn's disease  1  3/60 (5.00%)  3 3/59 (5.08%)  3 6/52 (11.54%)  6 7/52 (13.46%)  7
Diarrhoea  1  4/60 (6.67%)  4 0/59 (0.00%)  0 7/52 (13.46%)  7 7/52 (13.46%)  7
Nausea  1  3/60 (5.00%)  3 3/59 (5.08%)  3 5/52 (9.62%)  5 6/52 (11.54%)  6
Vomiting  1  2/60 (3.33%)  2 3/59 (5.08%)  3 8/52 (15.38%)  8 3/52 (5.77%)  3
Constipation  1  1/60 (1.67%)  1 2/59 (3.39%)  2 0/52 (0.00%)  0 5/52 (9.62%)  5
Toothache  1  1/60 (1.67%)  1 2/59 (3.39%)  2 4/52 (7.69%)  4 1/52 (1.92%)  1
General disorders         
Pyrexia  1  4/60 (6.67%)  4 1/59 (1.69%)  1 5/52 (9.62%)  5 3/52 (5.77%)  3
Asthenia  1  1/60 (1.67%)  1 2/59 (3.39%)  2 1/52 (1.92%)  1 5/52 (9.62%)  5
Infections and infestations         
Nasopharyngitis  1  6/60 (10.00%)  6 9/59 (15.25%)  9 8/52 (15.38%)  8 15/52 (28.85%)  15
Sinusitis  1  4/60 (6.67%)  4 0/59 (0.00%)  0 3/52 (5.77%)  3 1/52 (1.92%)  1
Gastroenteritis  1  0/60 (0.00%)  0 2/59 (3.39%)  2 5/52 (9.62%)  5 2/52 (3.85%)  2
Gastroenteritis viral  1  2/60 (3.33%)  2 1/59 (1.69%)  1 2/52 (3.85%)  2 2/52 (3.85%)  2
Influenza  1  1/60 (1.67%)  1 0/59 (0.00%)  0 8/52 (15.38%)  8 5/52 (9.62%)  5
Upper respiratory tract infection  1  1/60 (1.67%)  1 1/59 (1.69%)  1 8/52 (15.38%)  8 1/52 (1.92%)  1
Bronchitis  1  1/60 (1.67%)  1 1/59 (1.69%)  1 5/52 (9.62%)  5 2/52 (3.85%)  2
Urinary tract infection  1  1/60 (1.67%)  1 0/59 (0.00%)  0 4/52 (7.69%)  4 4/52 (7.69%)  4
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/60 (3.33%)  2 3/59 (5.08%)  3 5/52 (9.62%)  5 5/52 (9.62%)  5
Nervous system disorders         
Dizziness  1  0/60 (0.00%)  0 3/59 (5.08%)  3 1/52 (1.92%)  1 3/52 (5.77%)  3
Headache  1  4/60 (6.67%)  4 10/59 (16.95%)  10 12/52 (23.08%)  12 11/52 (21.15%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
A formal statistical analysis was not performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

(Note that this agreement language may appear in the study protocol)

Results Point of Contact
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Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01714726    
Other Study ID Numbers: D5170C00001
2012-004098-26 ( EudraCT Number )
First Submitted: October 24, 2012
First Posted: October 26, 2012
Results First Submitted: September 21, 2018
Results First Posted: March 6, 2019
Last Update Posted: March 6, 2019