Trial Outcomes & Findings for Inhibition of Anaphylaxis by Ibrutinib (NCT NCT03149315)

NCT ID: NCT03149315

Last Updated: 2025-01-17

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2025-01-17

Participant Flow

Participants were excluded if baseline skin prick tests to peanut/tree nuts were all negative.

Participant milestones

Measure	Ibrutinib All participants received 420 mg of ibrutinib orally for 2 to 7 days after undergoing baseline screening criteria.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhibition of Anaphylaxis by Ibrutinib

Baseline characteristics by cohort

Measure	All Participants n=6 Participants All participants received ibrutinib after undergoing baseline screening criteria.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.8 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants
Skin prick test to peanut and/or tree nuts	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

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).

Outcome measures

Measure	Ibrutinib n=6 Participants All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria.
Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods	2 doses Standard Deviation 0

SECONDARY outcome

Timeframe: 7 days

The primary outcome was to determine the fewest ibrutinib doses (2, 4, or 7 doses) required to suppress basophil reactivity (BAT). All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Basophil activation testing was perfmored at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib).

Outcome measures

Measure	Ibrutinib n=6 Participants All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria.
Number of Doses of Ibrutinib for Maximal Suppression of Basophil Reactivity	2 doses Standard Deviation 0

SECONDARY outcome

Timeframe: 30 days

Another secondary outcome was to determine the timing of when skin prick testing (SPT) response to peanut or tree nuts returned to baseline compared to basophil activation test (BAT) responses. Participants underwent SPT and BAT weekly after cessation of ibrutinib therapy. SPT and BAT that were ≥80% of baseline values were considered to have "returned to baseline."

Outcome measures

Measure	Ibrutinib n=6 Participants All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria.
Time to Recovery of Skin Test Reactivity	1.24 weeks Standard Deviation 0.6633

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=6 participants at risk All participants received ibrutinib after undergoing baseline screening criteria.
Respiratory, thoracic and mediastinal disorders Shortness of breath	16.7% 1/6 • Number of events 6 • Adverse events were monitored over a period of 4 months for each participant - this covers the time from enrollment (and baseline screening procedures) to the 3 month follow-up visit which included laboratory testing for potential toxicity.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 6 • Adverse events were monitored over a period of 4 months for each participant - this covers the time from enrollment (and baseline screening procedures) to the 3 month follow-up visit which included laboratory testing for potential toxicity.

Additional Information

Melanie Dispenza, MD, PhD

Johns Hopkins University School of Medicine

Phone: 410-550-1815

Email: mdispen1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place