Trial Outcomes & Findings for Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy (NCT NCT00932282)
NCT ID: NCT00932282
Last Updated: 2018-03-01
Results Overview
The primary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical tolerance as measured by passing an oral food challenge to 20 grams of peanut flour, 2-4 weeks after discontinuing peanut OIT therapy
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
approximately 24 or 36 months
Results posted on
2018-03-01
Participant Flow
Participant milestones
| Measure |
12 Month Maintenance of PnOIT
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
|
24 Month Maintenance of PnOIT
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
|
|---|---|---|
|
Pre-OIT Anti-IgE Therapy Phase
STARTED
|
7
|
6
|
|
Pre-OIT Anti-IgE Therapy Phase
COMPLETED
|
6
|
5
|
|
Pre-OIT Anti-IgE Therapy Phase
NOT COMPLETED
|
1
|
1
|
|
Modified OIT Rush Desensitization Phase
STARTED
|
6
|
5
|
|
Modified OIT Rush Desensitization Phase
COMPLETED
|
6
|
5
|
|
Modified OIT Rush Desensitization Phase
NOT COMPLETED
|
0
|
0
|
|
Biweekly OIT Buildup Phase
STARTED
|
6
|
5
|
|
Biweekly OIT Buildup Phase
COMPLETED
|
5
|
4
|
|
Biweekly OIT Buildup Phase
NOT COMPLETED
|
1
|
1
|
|
OIT Maintenance Phase
STARTED
|
5
|
4
|
|
OIT Maintenance Phase
COMPLETED
|
4
|
2
|
|
OIT Maintenance Phase
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy
Baseline characteristics by cohort
| Measure |
12 Month Maintenance of PnOIT
n=7 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
|
24 Month Maintenance of PnOIT
n=6 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.4 years
n=5 Participants
|
14.1 years
n=7 Participants
|
14.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 24 or 36 monthsThe primary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical tolerance as measured by passing an oral food challenge to 20 grams of peanut flour, 2-4 weeks after discontinuing peanut OIT therapy
Outcome measures
| Measure |
12 Month Maintenance of PnOIT
n=7 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
|
24 Month Maintenance of PnOIT
n=6 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
|
|---|---|---|
|
The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 monthsA secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to a peanut oral immunotherapy protocol allows for a higher amount of peanut tolerated after the rush desensitization phase, thereby reducing the duration of buildup phase and achieving maintenance dosing more rapidly
Outcome measures
| Measure |
12 Month Maintenance of PnOIT
n=7 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
|
24 Month Maintenance of PnOIT
n=6 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
|
|---|---|---|
|
The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour.
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: approximately 24 or 36 monthsA secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical desensitization as measured by passing an oral food challenge to 20 grams of peanut flour on the final day of peanut OIT dosing.
Outcome measures
| Measure |
12 Month Maintenance of PnOIT
n=7 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
|
24 Month Maintenance of PnOIT
n=6 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
|
|---|---|---|
|
The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge Following the Desensitization Phase of the Study
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: approximately 24 or 36 monthsA secondary safety outcome of the study is to determine the frequency of SAEs during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of SAEs that occur during oral immunotherapy when compared to previously published results
Outcome measures
| Measure |
12 Month Maintenance of PnOIT
n=7 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
|
24 Month Maintenance of PnOIT
n=6 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
|
|---|---|---|
|
Incidence of All Serious Adverse Events During the Study
|
0 SAEs per 100 OIT doses taken
|
0 SAEs per 100 OIT doses taken
|
SECONDARY outcome
Timeframe: approximately 24 or 36 monthsThe primary safety outcome of the study is to determine the frequency of side effects during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of allergic symptoms that occur during oral immunotherapy when compared to previously published results
Outcome measures
| Measure |
12 Month Maintenance of PnOIT
n=7 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
|
24 Month Maintenance of PnOIT
n=6 Participants
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
|
|---|---|---|
|
Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy
|
2.8 side effects reported per 100 OIT doses
|
3.0 side effects reported per 100 OIT doses
|
Adverse Events
12 Month Maintenance of PnOIT
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
24 Month Maintenance of PnOIT
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
12 Month Maintenance of PnOIT
n=7 participants at risk
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
|
24 Month Maintenance of PnOIT
n=6 participants at risk
Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
33.3%
2/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
0.00%
0/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Skin and subcutaneous tissue disorders
Erythematous rash
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
16.7%
1/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
0.00%
0/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
16.7%
1/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Skin and subcutaneous tissue disorders
Oropharyngeal itching
|
42.9%
3/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
33.3%
2/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
0.00%
0/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
16.7%
1/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Respiratory, thoracic and mediastinal disorders
Nose itch
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
0.00%
0/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Skin and subcutaneous tissue disorders
Skin itch
|
28.6%
2/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
16.7%
1/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Skin and subcutaneous tissue disorders
Eye or lip swelling
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
0.00%
0/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Eye disorders
Eye itch
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
0.00%
0/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Eye disorders
Eye tearing
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
0.00%
0/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Skin and subcutaneous tissue disorders
Hives
|
28.6%
2/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
16.7%
1/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Gastrointestinal disorders
Abdominal pain
|
42.9%
3/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
33.3%
2/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • AE data collected over approximately 24-36 months depending on patient randomization
|
0.00%
0/6 • AE data collected over approximately 24-36 months depending on patient randomization
|
Additional Information
Edwin Kim, Director UNC Food Allergy Initiative
University of North Carolina at Chapel Hill
Phone: 919-843-9087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place