Trial Outcomes & Findings for Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants (NCT NCT03881696)

NCT ID: NCT03881696

Last Updated: 2025-09-10

Results Overview

Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 471 participants
• Primary outcome timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation
• Results posted on: 2025-09-10

Participant Flow

Enrollment was open from July 2019 through March 2023.

471 Participants were enrolled during the recruitment period. 289 of the participants that enrolled did not meet the required eligibility criteria and therefore were considered trial screen failures. 180 participants went on to randomize in Stage 1. 2 participants met eligibility criteria after Stage 1 was completed and randomized directly into Stage 2.

Participant milestones

Measure	Omalizumab Omalizumab	Placebo for Omalizumab Placebo for Omalizumab
Overall Study STARTED	120	60
Overall Study COMPLETED	114	60
Overall Study NOT COMPLETED	6	0

Reasons for withdrawal

Measure	Omalizumab Omalizumab	Placebo for Omalizumab Placebo for Omalizumab
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	2	0
Overall Study Subject withdrawal by parent or guardian	1	0
Overall Study Failure to meet continuation criteria	1	0

Baseline Characteristics

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Baseline characteristics by cohort

Measure	Omalizumab n=120 Participants Omalizumab	Placebo for Omalizumab n=60 Participants Placebo for Omalizumab	Total n=180 Participants Total of all reporting groups
Age, Continuous	7.8 years STANDARD_DEVIATION 4.87 • n=5 Participants	8.0 years STANDARD_DEVIATION 5.19 • n=7 Participants	7.8 years STANDARD_DEVIATION 4.97 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	28 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	32 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	110 Participants n=5 Participants	56 Participants n=7 Participants	166 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	37 Participants n=7 Participants	111 Participants n=5 Participants
Race (NIH/OMB) More than one race	23 Participants n=5 Participants	7 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants	60 participants n=7 Participants	180 participants n=5 Participants
Body Mass Index	17.457 kg/m² STANDARD_DEVIATION 3.0438 • n=5 Participants	17.215 kg/m² STANDARD_DEVIATION 3.6763 • n=7 Participants	17.377 kg/m² STANDARD_DEVIATION 3.2599 • n=5 Participants

PRIMARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Population: Pediatric Full Analysis Set - Stage 1 (PFA-S1): All participants aged less than 18 years at randomization who have been randomized to either omalizumab or placebo for omalizumab in Stage 1. Participants will be analyzed according to the treatment arm to which they were randomized in Stage 1, regardless of the treatment actually received in Stage 1.

Number of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Measure	Omalizumab n=118 Participants Omalizumab	Placebo for Omalizumab n=59 Participants Placebo for Omalizumab
Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without Dose-Limiting Symptoms During the DBPCFC Conducted at the End of Treatment Stage 1 Success	79 Participants	4 Participants
Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without Dose-Limiting Symptoms During the DBPCFC Conducted at the End of Treatment Stage 1 Failure	39 Participants	55 Participants

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Number of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation]

Proportion of participants who successfully consume 2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume 2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume 2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume 2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume 2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume 2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume 2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants who successfully consume 2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 600 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold ≥ 1 dose of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of 2 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 1 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab or placebo for omalizumab. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥600 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume a single dose of ≥1000mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time Frame: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥1 dose of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume ≥2 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of milk protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of egg protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of wheat protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of cashew protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of hazelnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of walnut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for at least two treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants who successfully consume 3 doses of 2000 mg of food protein without dose-limiting symptoms for all three treated food allergens during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 600 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of ≥ 1 dose of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of 2 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the DBPCFC at the end of Stage 2: 60 to 64 Weeks after Stage 2 treatment initiation

Proportion of participants that were able to consume 0, 1, 2, or 3 foods at a threshold of 3 doses of 2000 mg food protein during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting, at the end of Stage 2 treatment, to compare the ability of participants to consume foods without dose-limiting symptoms during a DBPCFC after treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 20 Weeks after initiating Stage 1 randomized treatment initiation

To evaluate safety during treatment with either omalizumab or placebo for omalizumab during Stage 1 masked (blinded) treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 Weeks after initiating Stage 1 Open Label omalizumab study therapy regimen

To evaluate safety during this open label omalizumab study therapy regimen during Stage 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 64 Weeks after initiating Stage 2 study therapy regimen

To evaluate safety during treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT during Stage 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years after initiating Stage 3 Oral Food Intake regimen

To evaluate safety after the conclusion of treatment with either omalizumab-facilitated oral immunotherapy (OIT) or omalizumab + placebo OIT during a follow-up period in which participants either received guided dietary instructions and/or rescue OIT for up to three foods (Stage 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From initial 8-week period during Stage 3 up to the last possible 8-week period during Stage 3 (i.e., Up to N=13 possible 8-week intervals during a 2-year period of time in Stage 3)

To compare dietary consumption of foods after the conclusion of treatment with either omalizumab facilitated OIT or omalizumab + placebo OIT during a follow-up period in which participants either received guided dietary instructions and/or rescue oral immunotherapy (OIT) for up to three foods (Stage 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From initial 8-week period during Stage 3 up to the last possible 8-week period during Stage 3 (i.e., Up to N=13 possible 8-week intervals during a 2-year period of time in Stage 3)

To compare dietary consumption of foods after the conclusion of treatment with either omalizumab facilitated OIT or omalizumab + placebo OIT during a follow-up period in which participants either received guided dietary instructions and/or rescue oral immunotherapy (OIT) for up to three foods (Stage 3).

Outcome measures

Outcome data not reported

Adverse Events

Omalizumab

Serious events: 4 serious events

Other events: 62 other events

Deaths: 0 deaths

Placebo for Omalizumab

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omalizumab n=120 participants at risk Omalizumab	Placebo for Omalizumab n=60 participants at risk Placebo for Omalizumab
General disorders Systemic inflammatory response syndrome	0.83% 1/120 • Number of events 1 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	0.00% 0/60 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Immune system disorders Hypersensitivity	0.00% 0/120 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	1.7% 1/60 • Number of events 1 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Infections and infestations Infectious mononucleosis	0.83% 1/120 • Number of events 1 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	0.00% 0/60 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Investigations Liver function test increased	0.83% 1/120 • Number of events 1 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	0.00% 0/60 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Psychiatric disorders Depression	0.83% 1/120 • Number of events 1 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	0.00% 0/60 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Psychiatric disorders Suicidal ideation	0.83% 1/120 • Number of events 1 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	0.00% 0/60 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.

Other adverse events

Measure	Omalizumab n=120 participants at risk Omalizumab	Placebo for Omalizumab n=60 participants at risk Placebo for Omalizumab
Gastrointestinal disorders Diarrhoea	4.2% 5/120 • Number of events 5 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
General disorders Injection site reaction	9.2% 11/120 • Number of events 20 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	8.3% 5/60 • Number of events 6 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
General disorders Pyrexia	5.8% 7/120 • Number of events 7 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	3.3% 2/60 • Number of events 2 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Immune system disorders Hypersensitivity	20.8% 25/120 • Number of events 34 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	38.3% 23/60 • Number of events 34 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Infections and infestations Corona virus infection	6.7% 8/120 • Number of events 8 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Infections and infestations Gastroenteritis	1.7% 2/120 • Number of events 2 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 4 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Infections and infestations Influenza	2.5% 3/120 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 4 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Infections and infestations Nasopharyngitis	2.5% 3/120 • Number of events 4 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Infections and infestations Upper respiratory tract infection	4.2% 5/120 • Number of events 8 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Infections and infestations Viral infection	4.2% 5/120 • Number of events 6 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Respiratory, thoracic and mediastinal disorders Asthma	4.2% 5/120 • Number of events 5 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 5/120 • Number of events 5 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Skin and subcutaneous tissue disorders Eczema	3.3% 4/120 • Number of events 4 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 5 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/120 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.
Skin and subcutaneous tissue disorders Urticaria	2.5% 3/120 • Number of events 3 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.	5.0% 3/60 • Number of events 5 • Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study. Treatment-emergent AEs for all 180 participants that randomized into Stage 1. Reporting does not include the OLE period.

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 202-604-9855

Email: DAITClinicalTrialsGov@niaid.nih.gov

Results disclosure agreements

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