Phase 2 N=40 Randomized Triple-blind Treatment

A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial

Food Hypersensitivity · Hypersensitivity · Immediate Hypersensitivity · Peanut Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT00580606 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Oct 2012

Primary outcome: Primary: Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge — 70; 15 Percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Glycerinated peanut allergenic extract (Drug); Placebo for peanut extract (glycerin) (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge	70; 15	<0.001 sig
SECONDARY Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg	85.0; 95.0	—
SECONDARY Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption	43.8	—
SECONDARY Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg	88.2	—
SECONDARY Number of Participants With Serious Adverse Events (SAEs)	1; 0	—
SECONDARY Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption	—	—
SECONDARY Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder	10.0; 11.8	—

Summary

The purpose of this study is to evaluate the safety and immune response to daily sublingual (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with peanut allergies.

Eligibility Criteria

Inclusion Criteria

Physician-diagnosed peanut allergy OR convincing clinical history of peanut allergy
Reacts to a cumulative dose of 2,000 mg or less of peanut powder
Positive peanut allergy skin prick test OR detectable serum peanut-specific IgE level
Willing to use an acceptable method of contraception for the duration of the study
Ability to perform spirometry maneuver in accordance with the American Thoracic Society guidelines

Exclusion Criteria

History of severe anaphylaxis to peanut
Currently participating in a study using a new investigational new drug
Participation in any interventional study for the treatment of food allergy in the 12 months prior to study entry
Allergic to placebo ingredients (glycerin or oat flour) OR reacts to any dose of placebo during study entry oral food challenge (OFC)
Currently in a buildup phase of any allergy immunotherapy
Poor control of atopic dermatitis
Moderate or severe asthma despite therapy
Current treatment with greater than medium daily doses of inhaled corticosteroids
Use of steroid medications
Use of omalizumab or other nontraditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry
Use of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers
Inability to discontinue antihistamines for skin testing and OFCs
History of ischemic cardiovascular disease
History of alcohol or drug abuse
Other significant medical conditions that, in the opinion of the investigator, prevent participation in the study
Previous intubation due to allergies or asthma
Uncontrolled high blood pressure
Pregnancy or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00580606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.