Allergic AsthmaPhase 1NCT01544348
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
A Phase 1 study testing Omalizumab, MEDI4212 5 mg Subcutaneous and MEDI4212 15 mg Subcutaneous in people with Allergic Asthma and Atopic Dermatitis, run by MedImmune LLC at 7 sites in United States.
Trial summary
Phase 1 study to evaluate the safety of MEDI4212. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma, Atopic Dermatitis, Allergic Rhinitis
- What is being tested?
- Omalizumab, MEDI4212 5 mg Subcutaneous and MEDI4212 15 mg Subcutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Research Site
Baltimore, Maryland
Research Site
Cypress, California
Research Site
Denver, Colorado
Research Site
Glendale, California
Research Site
Madison, Wisconsin
Research Site
Miami, Florida
Research Site
Pittsburgh, Pennsylvania
About this study
Official title: A Phase 1 Randomized, Placebo-controlled, Dose-escalation Study to Evaluate the Safety of MEDI4212 in Subjects With IgE >= 30 IU/mL
Phase 1 study to evaluate the safety of MEDI4212.
Read the detailed description
A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects with immunoglobulin E (IgE) greater than or equal to (>=) 30 international units per milliliters (IU/mL).
- Being tested
- Placebo, Omalizumab, MEDI4212 5 mg Subcutaneous, MEDI4212 15 mg Subcutaneous, MEDI4212 60 mg Subcutaneous
- Keywords
- Allergic, Atopic Dermatitis, MEDI4212
- Medical subject headings
- Dermatitis, Atopic, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
OmalizumabBiological
Also called Xolair
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 SubcutaneousBiological
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
MEDI4212 15 mg SubcutaneousBiological
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
MEDI4212 60 mg SubcutaneousBiological
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
MEDI4212 150 mg SubcutaneousBiological
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
MEDI4212 300 mg SubcutaneousBiological
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
MEDI4212 300 mg IntravenousBiological
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1. Receives: Other: Placebo |
| Omalizumab | Active comparator | 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. Receives: Biological: Omalizumab |
| MEDI4212 5 mg Subcutaneous | Experimental | A single dose of MEDI4212 5 mg injection subcutaneously on Day 1. Receives: Biological: MEDI4212 5 mg Subcutaneous |
| MEDI4212 15 mg Subcutaneous | Experimental | A single dose of MEDI4212 15 mg injection subcutaneously on Day 1. Receives: Biological: MEDI4212 15 mg Subcutaneous |
| MEDI4212 60 mg Subcutaneous | Experimental | A single dose of MEDI4212 60 mg injection subcutaneously on Day 1. Receives: Biological: MEDI4212 60 mg Subcutaneous |
| MEDI4212 150 mg Subcutaneous | Experimental | A single dose of MEDI4212 150 mg injection subcutaneously on Day 1. Receives: Biological: MEDI4212 150 mg Subcutaneous |
| MEDI4212 300 mg Subcutaneous | Experimental | A single dose of MEDI4212 300 mg injection subcutaneously on Day 1. Receives: Biological: MEDI4212 300 mg Subcutaneous |
| MEDI4212 300 mg Intravenous | Experimental | A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1. Receives: Biological: MEDI4212 300 mg Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to 85
Secondary outcomes (3)
Observed Serum Concentration
Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.
Measured: 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
Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.
Measured: Days 1 (pre-dose), 15, 43, and 85
Free Immunoglobulin E (IgE) Serum Concentration
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544348
- Sponsor's protocol ID
- CD-RI-MEDI4212-1085
- Status last verified
- Dec 2014
- First submitted
- 31 Jan 2012
- Last updated
- 30 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26843086
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Placebo-controlled, Dose-escalation Study to Evaluate the Safety of MEDI4212 in Subjects With IgE >= 30 IU/mL
- ClinicalTrials.gov ID
- NCT01544348
- Acronym / sponsor ID
- CD-RI-MEDI4212-1085
- Keywords
- Allergic, Atopic Dermatitis, MEDI4212
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Posted 30 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 study to evaluate the safety of MEDI4212.
Detailed description
A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects with immunoglobulin E (IgE) greater than or equal to (>=) 30 international units per milliliters (IU/mL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboA single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1. |
| Omalizumab | Active comparator | Biological: OmalizumabA 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 | Experimental | Biological: MEDI4212 5 mg SubcutaneousA single dose of MEDI4212 5 mg injection subcutaneously on Day 1. |
| MEDI4212 15 mg Subcutaneous | Experimental | Biological: MEDI4212 15 mg SubcutaneousA single dose of MEDI4212 15 mg injection subcutaneously on Day 1. |
| MEDI4212 60 mg Subcutaneous | Experimental | Biological: MEDI4212 60 mg SubcutaneousA single dose of MEDI4212 60 mg injection subcutaneously on Day 1. |
| MEDI4212 150 mg Subcutaneous | Experimental | Biological: MEDI4212 150 mg SubcutaneousA single dose of MEDI4212 150 mg injection subcutaneously on Day 1. |
| MEDI4212 300 mg Subcutaneous | Experimental | Biological: MEDI4212 300 mg SubcutaneousA single dose of MEDI4212 300 mg injection subcutaneously on Day 1. |
| MEDI4212 300 mg Intravenous | Experimental | Biological: MEDI4212 300 mg IntravenousA single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboA single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1. | Other | Placebo |
| OmalizumabAlso: XolairA 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. | Biological | Omalizumab |
| MEDI4212 5 mg SubcutaneousA single dose of MEDI4212 5 mg injection subcutaneously on Day 1. | Biological | MEDI4212 5 mg Subcutaneous |
| MEDI4212 15 mg SubcutaneousA single dose of MEDI4212 15 mg injection subcutaneously on Day 1. | Biological | MEDI4212 15 mg Subcutaneous |
| MEDI4212 60 mg SubcutaneousA single dose of MEDI4212 60 mg injection subcutaneously on Day 1. | Biological | MEDI4212 60 mg Subcutaneous |
| MEDI4212 150 mg SubcutaneousA single dose of MEDI4212 150 mg injection subcutaneously on Day 1. | Biological | MEDI4212 150 mg Subcutaneous |
| MEDI4212 300 mg SubcutaneousA single dose of MEDI4212 300 mg injection subcutaneously on Day 1. | Biological | MEDI4212 300 mg Subcutaneous |
| MEDI4212 300 mg IntravenousA single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1. | Biological | MEDI4212 300 mg Intravenous |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 to 85
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.
3 secondary outcomes
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
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit
Time frame: Days 1 (pre-dose), 15, 43, and 85
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26843086Sheldon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omalizumab, MEDI4212 5 mg Subcutaneous and MEDI4212 15 mg Subcutaneous in people with Allergic Asthma and Atopic Dermatitis, run by MedImmune LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 to 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.