Trial Outcomes & Findings for Xolair Enhances Oral Desensitization in Peanut Allergic Patients (NCT NCT01290913)

NCT ID: NCT01290913

Last Updated: 2015-04-07

Results Overview

To tolerate refers to the ability of the patient to ingest the challenge dose of 500 mg peanut flour (1000 mg cumulatively) with either no or mild symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: First day of desensitization
• Results posted on: 2015-04-07

Participant Flow

Participant milestones

Measure	Omalizumab, Oral Desensitization Omalizumab treatment and oral peanut desensitization
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Xolair Enhances Oral Desensitization in Peanut Allergic Patients

Baseline characteristics by cohort

Measure	Omalizumab, Oral Desensitization n=13 Participants Omalizumab treatment and oral peanut desensitization
Age, Categorical <=18 years	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: First day of desensitization

To tolerate refers to the ability of the patient to ingest the challenge dose of 500 mg peanut flour (1000 mg cumulatively) with either no or mild symptoms.

Outcome measures

Measure	Omalizumab, Oral Desensitization n=13 Participants Omalizumab treatment and oral peanut desensitization
Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg)	13 participants

SECONDARY outcome

Timeframe: after 7-8 wks of desensitization

To tolerate refers to the ability of the patient to ingest the final challenge of 4000mg peanut flour, with either no or mild symptoms.

Outcome measures

Measure	Omalizumab, Oral Desensitization n=13 Participants Omalizumab treatment and oral peanut desensitization
Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 4,000 mg of Peanut Flour.	12 participants

Adverse Events

Omalizumab, Oral Desensitization

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omalizumab, Oral Desensitization n=13 participants at risk Omalizumab treatment and oral peanut desensitization
General disorders Anaphylaxis	15.4% 2/13 • Number of events 2

Other adverse events

Measure	Omalizumab, Oral Desensitization n=13 participants at risk Omalizumab treatment and oral peanut desensitization
Immune system disorders Allergic Reaction	76.9% 10/13

Additional Information

Clinical Coordinator

Boston Children's Hospital

Phone: 6173556127

Email: sara.little@childrens.harvard.edu

Results disclosure agreements

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