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Trial · NCT01003301

The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge

NCT01003301, Phase 2, Completed, Johns Hopkins University; results first posted 2014-04-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge. Trials, record NCT01003301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01003301

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge
NCT number
NCT01003301
Status
Completed
Phases
Phase 2
Enrollment
19 participants, actual
Lead sponsor
Johns Hopkins University
Conditions
Cat Allergy
Interventions
Omalizumab, Placebo
First posted
2009-10-28
Last updated
2014-04-07
Results first posted
2014-04-07

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe the Size of the 8 Late-phase Skin ResponseBaseline, 2-6 wksReduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYThe the Size of the 8 Late-phase Skin ResponseBaseline, 2-6 wkspercentage decline from NAC-1MEAN

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
The the Size of the 8 Late-phase Skin ResponseOmalizumab54Standard Deviation 4percentage decline from NAC-1
The the Size of the 8 Late-phase Skin ResponsePlacebo0Standard Deviation 5percentage decline from NAC-1

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDOmalizumab10
Overall StudySTARTEDPlacebo9
Overall StudyCOMPLETEDOmalizumab10
Overall StudyCOMPLETEDPlacebo9
Overall StudyNOT COMPLETEDOmalizumab0
Overall StudyNOT COMPLETEDPlacebo0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityOmalizumab
Total, all-cause mortalityPlacebo
Total, other adverse eventsOmalizumab010
Total, other adverse eventsPlacebo09
Total, serious adverse eventsOmalizumab010
Total, serious adverse eventsPlacebo09

Papers30

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
1607547BACKGROUNDPubMed
2582257BACKGROUNDPubMed
8360482BACKGROUNDPubMed
9013989BACKGROUNDPubMed
9196082BACKGROUNDPubMed
9215248BACKGROUNDPubMed
9257795BACKGROUNDPubMed
9517609BACKGROUNDPubMed
10228046BACKGROUNDPubMed
10932067BACKGROUNDPubMed

1 to 10 of 30

See all 30 papers

Grants1

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U19AI070345Efficacy of IgE in Mediating Allergic Reactions in VivoMACGLASHAN, DONALD WJOHNS HOPKINS UNIVERSITYNATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES2006 to 2010

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Omalizumab vs Placebo: serious adverse events

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT01003301

GET https://conductscience.org/api/trials/v1/NCT01003301/papers?page=2