Trial Outcomes & Findings for A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy (NCT NCT01084174)
NCT ID: NCT01084174
Last Updated: 2017-04-07
Results Overview
Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
12 months
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Active SLIT/Placebo OIT
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Active SLIT/Placebo OIT
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Overall Study
gastrointestinal symptoms
|
1
|
1
|
|
Overall Study
Eosinophilic esophagitis
|
0
|
1
|
|
Overall Study
Anaphylaxis
|
0
|
1
|
|
Overall Study
Participant noncompliance
|
0
|
1
|
Baseline Characteristics
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
Baseline characteristics by cohort
| Measure |
Active SLIT/Placebo OIT
n=10 Participants
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
n=11 Participants
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Prior history of peanut anaphylaxis
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Other food allergies
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Atopic dermatitis
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPeanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.
Outcome measures
| Measure |
Active SLIT/Placebo OIT
n=9 Participants
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
n=7 Participants
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Number of Participants With Induced Peanut Desensitization at 12 Months
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and end of dose build-up (up to 16 weeks)Serum immunoglobulin G4 (IgG4) levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at the end of dose build-up (up to 16 weeks)
Outcome measures
| Measure |
Active SLIT/Placebo OIT
n=10 Participants
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
n=11 Participants
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)
Baseline
|
0.9 mga/L
Interval 0.19 to 1.76
|
1.3 mga/L
Interval 0.22 to 5.89
|
|
Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)
End of dose build-up (up to 16 weeks)
|
2.5 mga/L
Interval 0.47 to 7.07
|
11.3 mga/L
Interval 0.99 to 58.7
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: One participant in the Active sublingual immunotherapy (SLIT)/Placebo oral immunotherapy (OIT) arm and 4 participants in the Active OIT/Placebo SLIT arm discontinued prior to month 6.
IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 6 months
Outcome measures
| Measure |
Active SLIT/Placebo OIT
n=9 Participants
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
n=7 Participants
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Between Arm Change in IgG4 From Baseline to 6 Months
Baseline
|
0.9 mga/L
Interval 0.19 to 1.76
|
1.3 mga/L
Interval 0.22 to 5.89
|
|
Between Arm Change in IgG4 From Baseline to 6 Months
6 months
|
7.9 mga/L
Interval 1.51 to 76.2
|
83.4 mga/L
Interval 21.2 to 677.0
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: One participant in the Active SLIT/Placebo OIT arm and 4 participants in the Active OIT/Placebo SLIT arm discontinued prior to month 12.
IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 12 months
Outcome measures
| Measure |
Active SLIT/Placebo OIT
n=9 Participants
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
n=7 Participants
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Between Arm Change in IgG4 From Baseline to 12 Months
Baseline
|
0.9 mga/L
Interval 0.19 to 1.76
|
1.3 mga/L
Interval 0.22 to 5.89
|
|
Between Arm Change in IgG4 From Baseline to 12 Months
12 months
|
8.5 mga/L
Interval 2.42 to 69.1
|
76 mga/L
Interval 28.8 to 1790.0
|
SECONDARY outcome
Timeframe: Baseline to end of dose build-up (up to 16 weeks)Outcome measures
| Measure |
Active SLIT/Placebo OIT
n=9 Participants
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
n=7 Participants
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)
Baseline
|
163 kUa/L
Interval 37.5 to 746.0
|
169 kUa/L
Interval 35.1 to 716.0
|
|
Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)
End of dose build-up (up to 16 weeks)
|
369 kUa/L
Interval 47.4 to 1960.0
|
392 kUa/L
Interval 84.0 to 1069.0
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsSerum immunoglobulin E (IgE) levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 6 months
Outcome measures
| Measure |
Active SLIT/Placebo OIT
n=9 Participants
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
n=7 Participants
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Between Arm Change in IgE From Baseline to 6 Months
Baseline
|
163 kUa/L
Interval 37.5 to 746.0
|
169 kUa/L
Interval 35.1 to 716.0
|
|
Between Arm Change in IgE From Baseline to 6 Months
6 months
|
387 kUa/L
Interval 34.1 to 1032.0
|
68 kUa/L
Interval 50.9 to 204.0
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsIgE levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 12 months
Outcome measures
| Measure |
Active SLIT/Placebo OIT
n=9 Participants
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Peanut powder: Delivered orally
Placebo extract: Delivered sublingually
|
Active OIT/Placebo SLIT
n=7 Participants
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Peanut extract: Delivered sublingually
Placebo powder: Delivered orally
|
|---|---|---|
|
Between Arm Change in IgE From Baseline to 12 Months
12 months
|
273 kUa/L
Interval 21.0 to 1111.0
|
53 kUa/L
Interval 32.4 to 82.9
|
|
Between Arm Change in IgE From Baseline to 12 Months
Baseline
|
163 kUa/L
Interval 37.5 to 746.0
|
169 kUa/L
Interval 35.1 to 716.0
|
Adverse Events
Active SLIT/Placebo OIT
Serious events: 0 serious events
Other events: 416 other events
Deaths: 0 deaths
Active OIT/Placebo SLIT
Serious events: 0 serious events
Other events: 1736 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active SLIT/Placebo OIT
n=4578 participants at risk
Adverse event information is based on percentages of doses. There were 4578 total doses in the Active SLIT/Placebo OIT treatment arm
|
Active OIT/Placebo SLIT
n=4049 participants at risk
Adverse event information is based on percentages of doses. There were 4049 total doses in the Active OIT/Placebo SLIT treatment arm
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
7.1%
325/4578 • Number of events 325
|
33.2%
1344/4049 • Number of events 1344
|
|
Skin and subcutaneous tissue disorders
skin symptoms
|
1.4%
64/4578 • Number of events 64
|
2.8%
113/4049 • Number of events 113
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Symptoms
|
0.59%
27/4578 • Number of events 27
|
6.9%
279/4049 • Number of events 279
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place