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NCT03149315 · ClinicalTrials.gov registry record · Phase 2

Inhibition of Anaphylaxis by Ibrutinib

A Phase 2 study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

Completed
Registry status
Phase 2
Development phase
6
Enrollment target

NCT03149315: Completed Phase 2 study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

NCT03149315 is a Phase 2 study that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03149315, a Phase 2 study, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

COMPLETED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's macroglobulineia (WM). We propose to administer this approved drug to adults with food allergy to inhibit food allergy responses.

Primary Outcome

The primary outcome was the number of ibrutinib doses (2, 4, or 7 doses) required to maximally suppress food skin prick reactivity to foods. All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Skin testing to peant and tree nuts was done at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib).

Interventions

  • DRUG Ibrutinib

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2017-04-10
Est. Completion 2018-11-14
Phase Phase 2

What the finished NCT03149315 record still lists

NCT03149315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Ibrutinib is the first listed.

NCT03149315 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03149315 about?

NCT03149315 is a clinical study titled "Inhibition of Anaphylaxis by Ibrutinib". This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's mac...

What is the current status of trial NCT03149315?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2017-04-10. Estimated completion is 2018-11-14.

What interventions are being tested in trial NCT03149315?

The interventions under investigation include: Ibrutinib (DRUG).

Who is sponsoring clinical trial NCT03149315?

This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03149315's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03149315, the US trial registry maintained by the National Library of Medicine. NCT03149315 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.