A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
NCT ID: NCT01544348
Last Updated: 2014-12-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
295 participants
INTERVENTIONAL
2012-01-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
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.
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 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 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 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 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 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.
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent and any locally required authorization
* Body weight 45-150 kilogram (kg) for Cohorts 1-3, 4b, and 5-9. Body weight 45-90 kg for Cohort 4a
* Females must have been surgically sterilized or postmenopausal
* Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85; Both partners to use contraception
* Sterilized males must be at least 1-year post vasectomy or use a highly effective contraceptive method
* Healthy Japanese population as determined by a responsible physician
* Current diagnosis of allergic rhinitis, allergic asthma, or atopic dermatitis (cohorts 1-6) with a diagnostic immunoglobulin E (IgE) of 30 international units per milliliter (IU/mL) at Screening. Diagnostic IgE levels are further restricted for subjects enrolling into each cohort, with the following levels required at Screening: Cohorts 1 and 2: 30-700 IU/mL; Cohort 3: 30-700 IU/mL (4 subjects), greater than (\>) 700-1,200 IU/mL (4 subjects), and \>1,200 IU/mL (4 subjects); Cohort 4a: 30-500 IU/mL; Cohort 4b: \>700 IU/mL; Cohorts 5 and 6: 30-700 IU/mL (4 subjects per cohort) and \>700 IU/mL (6 subjects per cohort) or Japanese Cohorts 7-9: greater than or equal to (\>=) 30 IU/mL
* Nonsmoker for \>=6 months
* Obsolete criteria as no longer require Positive in vitro IgE fluorescence enzyme immunoassay (FEIA) response
* A forced expiration volume in one second (FEV1) \>= 80 percent (%) predicted in subjects with asthma. Non-asthmatic subjects with FEV1 \>=80% predicted, or with FEV1 less than (\<) 80% predicted but who, in the opinion of the investigator, do not have lung disease
* Ability and willingness to complete the follow-up period through Day 85 as required by the protocol.
Exclusion Criteria
* Concurrent enrollment in another clinical study
* Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
* Exposure to an anti-IgE monoclonal antibodies (MAb) within 12 months prior to Screening
* Positive drug screen at Screening or Day -1. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines
* History of regular alcohol abuse within 12 months prior to Screening
* History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation
* Subjects with abnormal liver function test values (aspartate transaminase \[AST\] and alanine transaminase \[ALT\]) at Screening as defined as follows: a) Liver function test values \>= 1.5 times upper limit of normal (ULN)
* Unwillingness or inability to follow the procedures outlined in the protocol
* Positive test or history of hepatitis B or positive hepatitis C
* Positive test or history of human immunodeficiency virus (HIV) or subject is known to be HIV seropositive
* History of cancer, with the exception of basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success
* Women who are pregnant, breastfeeding, or lactating
* Plans to donate blood during the study period
* Hyper-IgE syndrome or bronchopulmonary aspergillosis
* Prior history of Immune Complex Disease or type 3 hypersensitivity reactions to MAb administration
* Known history of prior infusion reaction to MAb administration
* History of untreated parasitic/helminthic infection within 6 months prior to Screening
* Uses any of the following medications: a) Oral corticosteroids b) Medium to high dose Immunocorticosteroids (ICS)/ long-acting beta agonists (LABA) c) Immunosuppressives d) Beta blockers
* If receiving allergy immunotherapy, must be on stable dose for 3 months. Must not receive allergy immunotherapy within 7 days of investigational product administration.
18 Years
60 Years
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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Research Site
Cypress, California, United States
Research Site
Glendale, California, United States
Research Site
Denver, Colorado, United States
Research Site
Miami, Florida, United States
Research Site
Baltimore, Maryland, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Madison, Wisconsin, United States
Countries
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References
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Sheldon E, Schwickart M, Li J, Kim K, Crouch S, Parveen S, Kell C, Birrell C. Pharmacokinetics, Pharmacodynamics, and Safety of MEDI4212, an Anti-IgE Monoclonal Antibody, in Subjects with Atopy: A Phase I Study. Adv Ther. 2016 Feb;33(2):225-51. doi: 10.1007/s12325-016-0287-8. Epub 2016 Feb 3.
Other Identifiers
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CD-RI-MEDI4212-1085
Identifier Type: -
Identifier Source: org_study_id