A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
A Phase 1 Randomized, Placebo-controlled, Dose-escalation Study to Evaluate the Safety of MEDI4212 in Subjects With IgE >= 30 IU/mL
1 other identifier
interventional
295
1 country
7
Brief Summary
Phase 1 study to evaluate the safety of MEDI4212.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2012
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
December 30, 2014
CompletedDecember 30, 2014
December 1, 2014
1.4 years
January 31, 2012
December 18, 2014
December 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
Day 1 to 85
Secondary Outcomes (3)
Observed Serum Concentration
Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit
Days 1 (pre-dose), 15, 43, and 85
Free Immunoglobulin E (IgE) Serum Concentration
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
Study Arms (8)
Placebo
PLACEBO COMPARATORA single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
Omalizumab
ACTIVE COMPARATORA 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
EXPERIMENTALA single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
MEDI4212 15 mg Subcutaneous
EXPERIMENTALA single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
MEDI4212 60 mg Subcutaneous
EXPERIMENTALA single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
MEDI4212 150 mg Subcutaneous
EXPERIMENTALA single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
MEDI4212 300 mg Subcutaneous
EXPERIMENTALA single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
MEDI4212 300 mg Intravenous
EXPERIMENTALA single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Interventions
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
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.
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Eligibility Criteria
You may qualify if:
- Age 18 through 60 years
- 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.
You may not qualify if:
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (7)
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
Related Publications (1)
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.
PMID: 26843086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Claire Birrell, Senior Clinical Scientist
- Organization
- MedImmune
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2012
First Posted
March 5, 2012
Study Start
January 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 30, 2014
Results First Posted
December 30, 2014
Record last verified: 2014-12