Trial · NCT01544348
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
NCT01544348, Phase 1, Completed, MedImmune LLC; results first posted 2014-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL. Trials, record NCT01544348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01544348
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
- NCT number
- NCT01544348
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 295 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Allergic Asthma, Atopic Dermatitis, Allergic Rhinitis, Healthy Volunteers
- Interventions
- 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
- First posted
- 2012-03-05
- Last updated
- 2014-12-30
- Results first posted
- 2014-12-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | 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. |
| Secondary | Observed Serum Concentration | Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85 | Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively. |
| Secondary | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | Days 1 (pre-dose), 15, 43, and 85 | Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis. |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 1 to 85 | Safety population included all participants who received any amount of investigational product and had safety data available. | participants | NUMBER |
| SECONDARY | Observed Serum Concentration | Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85 | Pharmacokinetic (PK) population included all participants who received any investigational product and had a sufficient number of serum concentration measurements for computing PK parameters. Here 'n' signifies participants evaluable for this outcome measure at specified time point, for each group respectively | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit | Days 1 (pre-dose), 15, 43, and 85 | Immunogenicity population included all participants who received any investigational product and had at least one valid immunogenicity test result. | participants | NUMBER |
| SECONDARY | 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 | Safety population included all participants who received any amount of investigational product and had safety data available. 'n' signifies those participants who evaluable for this outcome measure at specified time point for each group, respectively. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group219
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Placebo | TEAEs | 8 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Omalizumab | TEAEs | 2 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI4212 5 mg Subcutaneous | TEAEs | 2 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI4212 15 mg Subcutaneous | TEAEs | 1 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI4212 60 mg Subcutaneous | TEAEs | 4 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI4212 150 mg Subcutaneous | TEAEs | 9 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI4212 300 mg Subcutaneous | TEAEs | 7 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI4212 300 mg Intravenous | TEAEs | 6 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Placebo | TESAEs | 0 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Omalizumab | TESAEs | 0 | participants |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | STARTED | Omalizumab | 6 | |
| Overall Study | STARTED | MEDI4212 5 mg Subcutaneous | 3 | |
| Overall Study | STARTED | MEDI4212 15 mg Subcutaneous | 3 | |
| Overall Study | STARTED | MEDI4212 60 mg Subcutaneous | 16 | |
| Overall Study | STARTED | MEDI4212 150 mg Subcutaneous | 19 | |
| Overall Study | STARTED | MEDI4212 300 mg Subcutaneous | 14 | |
| Overall Study | STARTED | MEDI4212 300 mg Intravenous | 8 | |
| Overall Study | Treated | Placebo | 17 | |
| Overall Study | Treated | Omalizumab | 6 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events360
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Placebo | 1 | 17 | 1 |
| other | Palpitations | Cardiac disorders | Omalizumab | 0 | 6 | 0 |
| other | Palpitations | Cardiac disorders | MEDI4212 5 mg Subcutaneous | 0 | 3 | 0 |
| other | Palpitations | Cardiac disorders | MEDI4212 15 mg Subcutaneous | 0 | 3 | 0 |
| other | Palpitations | Cardiac disorders | MEDI4212 60 mg Subcutaneous | 0 | 15 | 0 |
| other | Palpitations | Cardiac disorders | MEDI4212 150 mg Subcutaneous | 0 | 18 | 0 |
| other | Palpitations | Cardiac disorders | MEDI4212 300 mg Subcutaneous | 0 | 14 | 0 |
| other | Palpitations | Cardiac disorders | MEDI4212 300 mg Intravenous | 0 | 8 | 0 |
| other | Dermoid cyst | Congenital, familial and genetic disorders | Placebo | 1 | 17 | 1 |
| other | Dermoid cyst | Congenital, familial and genetic disorders | Omalizumab | 0 | 6 | 0 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Omalizumab | ||
| Total, all-cause mortality | MEDI4212 5 mg Subcutaneous | ||
| Total, all-cause mortality | MEDI4212 15 mg Subcutaneous | ||
| Total, all-cause mortality | MEDI4212 60 mg Subcutaneous | ||
| Total, all-cause mortality | MEDI4212 150 mg Subcutaneous | ||
| Total, all-cause mortality | MEDI4212 300 mg Subcutaneous | ||
| Total, all-cause mortality | MEDI4212 300 mg Intravenous | ||
| Total, other adverse events | Placebo | 8 | 17 |
| Total, other adverse events | Omalizumab | 2 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26843086 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01544348
GET https://conductscience.org/api/trials/v1/NCT01544348/results?page=2