Trial Outcomes & Findings for Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial (NCT NCT01781637)
NCT ID: NCT01781637
Last Updated: 2023-02-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
6 weeks after last dose of omalizumab/placebo
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
Omalizumab Group
Patients will receive omalizumab.
Omalizumab: subcutaneous injection
|
Placebo
Patients will receive placebo.
placebo: subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
8
|
|
Overall Study
COMPLETED
|
24
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Omalizumab Group
Patients will receive omalizumab.
Omalizumab: subcutaneous injection
|
Placebo
Patients will receive placebo.
placebo: subcutaneous injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One subject declined treatment after being randomized but before beginning treatment
Baseline characteristics by cohort
| Measure |
Omalizumab Group
n=29 Participants
Patients will receive omalizumab.
Omalizumab: subcutaneous injection
|
Placebo
n=8 Participants
Patients will receive placebo.
placebo: subcutaneous injection
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10 years
n=5 Participants
|
10 years
n=7 Participants
|
10 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Baseline population
|
29 Participants
n=5 Participants • One subject declined treatment after being randomized but before beginning treatment
|
8 Participants
n=7 Participants • One subject declined treatment after being randomized but before beginning treatment
|
37 Participants
n=5 Participants • One subject declined treatment after being randomized but before beginning treatment
|
PRIMARY outcome
Timeframe: 6 weeks after last dose of omalizumab/placeboOutcome measures
| Measure |
Omalizumab Group
n=29 Participants
Patients will receive omalizumab.
Omalizumab: subcutaneous injection
|
Placebo
n=8 Participants
Patients will receive placebo.
placebo: subcutaneous injection
|
|---|---|---|
|
Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
|
23 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after last dose of omalizumab/placeboOutcome measures
| Measure |
Omalizumab Group
n=29 Participants
Patients will receive omalizumab.
Omalizumab: subcutaneous injection
|
Placebo
n=8 Participants
Patients will receive placebo.
placebo: subcutaneous injection
|
|---|---|---|
|
Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo
|
20 Participants
|
1 Participants
|
Adverse Events
Omalizumab Group
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omalizumab Group
n=28 participants at risk
Patients will receive omalizumab.
Omalizumab: subcutaneous injection
|
Placebo
n=8 participants at risk
Patients will receive placebo.
placebo: subcutaneous injection
|
|---|---|---|
|
Immune system disorders
Anaphylaxis
|
10.7%
3/28 • Number of events 3
|
37.5%
3/8 • Number of events 3
|
|
Psychiatric disorders
Psychiatric
|
3.6%
1/28 • Number of events 1
|
0.00%
0/8
|
Other adverse events
| Measure |
Omalizumab Group
n=28 participants at risk
Patients will receive omalizumab.
Omalizumab: subcutaneous injection
|
Placebo
n=8 participants at risk
Patients will receive placebo.
placebo: subcutaneous injection
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
35.7%
10/28
|
62.5%
5/8
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
14.3%
4/28
|
0.00%
0/8
|
|
Immune system disorders
Anaphylaxis
|
7.1%
2/28
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
6/28
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
4/28
|
0.00%
0/8
|
|
General disorders
Fever
|
7.1%
2/28
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
39.3%
11/28
|
25.0%
2/8
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.1%
9/28
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
10.7%
3/28
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
7.1%
2/28
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
10.7%
3/28
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/28
|
25.0%
2/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28
|
25.0%
2/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place