A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01544348
First received: January 31, 2012
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Allergic Asthma
Atopic Dermatitis
Allergic Rhinitis
Healthy Volunteers
Interventions: Other: Placebo
Biological: Omalizumab
Biological: MEDI4212 5 mg Subcutaneous
Biological: MEDI4212 15 mg Subcutaneous
Biological: MEDI4212 60 mg Subcutaneous
Biological: MEDI4212 150 mg Subcutaneous
Biological: MEDI4212 300 mg Subcutaneous
Biological: MEDI4212 300 mg Intravenous

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 295 participants were screened, out of which 209 were screen failures and 86 were randomized.

Reporting Groups
  Description
Placebo A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
Omalizumab A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
MEDI4212 5 mg Subcutaneous A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
MEDI4212 15 mg Subcutaneous A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
MEDI4212 60 mg Subcutaneous A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
MEDI4212 150 mg Subcutaneous A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
MEDI4212 300 mg Subcutaneous A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
MEDI4212 300 mg Intravenous A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.

Participant Flow:   Overall Study
    Placebo     Omalizumab     MEDI4212 5 mg Subcutaneous     MEDI4212 15 mg Subcutaneous     MEDI4212 60 mg Subcutaneous     MEDI4212 150 mg Subcutaneous     MEDI4212 300 mg Subcutaneous     MEDI4212 300 mg Intravenous  
STARTED     17     6     3     3     16     19     14     8  
Treated     17     6     3     3     15     18     14     8  
COMPLETED     15     6     3     3     15     16     12     8  
NOT COMPLETED     2     0     0     0     1     3     2     0  
Lost to Follow-up                 1                 0                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 1                 0                 0                 0                 1                 2                 1                 0  
Physician Decision                 0                 0                 0                 0                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all participants who received any amount of investigational product and had safety data available.

Reporting Groups
  Description
Placebo A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
Omalizumab A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
MEDI4212 5 mg Subcutaneous A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
MEDI4212 15 mg Subcutaneous A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
MEDI4212 60 mg Subcutaneous A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
MEDI4212 150 mg Subcutaneous A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
MEDI4212 300 mg Subcutaneous A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
MEDI4212 300 mg Intravenous A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Total Total of all reporting groups

Baseline Measures
    Placebo     Omalizumab     MEDI4212 5 mg Subcutaneous     MEDI4212 15 mg Subcutaneous     MEDI4212 60 mg Subcutaneous     MEDI4212 150 mg Subcutaneous     MEDI4212 300 mg Subcutaneous     MEDI4212 300 mg Intravenous     Total  
Number of Participants  
[units: participants]
  17     6     3     3     15     18     14     8     84  
Age  
[units: years]
Mean ± Standard Deviation
  39.6  ± 12.6     39.3  ± 9.2     44.7  ± 3.2     40.3  ± 9.6     38.7  ± 12.5     40.3  ± 11.1     35.9  ± 13.1     38.0  ± 8.6     39.0  ± 11.2  
Gender  
[units: participants]
                 
Female     7     2     1     2     4     4     2     0     22  
Male     10     4     2     1     11     14     12     8     62  



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)   [ Time Frame: Day 1 to 85 ]

2.  Secondary:   Observed Serum Concentration   [ Time Frame: Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85 ]

3.  Secondary:   Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit   [ Time Frame: Days 1 (pre-dose), 15, 43, and 85 ]

4.  Secondary:   Free Immunoglobulin E (IgE) Serum Concentration   [ Time Frame: Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Claire Birrell, Senior Clinical Scientist
Organization: MedImmune
phone: 301-398-0000
e-mail: birrellc@medimmune.com


No publications provided


Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01544348     History of Changes
Other Study ID Numbers: CD-RI-MEDI4212-1085
Study First Received: January 31, 2012
Results First Received: December 18, 2014
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration