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

Peanut allergy is a common ailment in the United States. Research suggests that the
prevalence of peanut allergy in the United States has doubled over the last 5 years.
Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick
access to self-injectable epinephrine in the event of peanut exposure. The sublingual route
is a potential method to administer immunotherapy for the treatment of food allergies. The
intent of this study is to induce desensitization and eventually tolerance to peanut protein
and evaluate the safety and immunologic effects of daily sublingual immunotherapy (SLIT) for
individuals with peanut allergy. The trial will enroll 40 participants. After the first 10
participants between the ages of 18 and 40 are enrolled, safety information will be reviewed.
If there are no safety concerns, the study will continue to enroll the remaining participants
between the ages of 12 and 40.

This clinical trial will last 172 to 216 weeks. Participants will be randomly assigned to
receive peanut SLIT or placebo SLIT. All participants will have an entry oral food challenge
(OFC). The treatment group will receive gradual dosing escalations of peanut SLIT and
maintenance therapy over a 44-week period, followed by another OFC. Following the OFC,
participants will be unblinded, and the placebo group will receive peanut SLIT escalated to a
higher maximum dose than the first treatment group. Maintenance therapy will continue for
both groups for more than 2 years.

Study visits will occur every 2 weeks during dosing escalations of peanut SLIT, followed by
visits gradually spacing out during maintenance to every 12 weeks. At selected visits, a
physical examination, skin prick tests, blood and urine collection, and atopic dermatitis and
asthma evaluations will occur. Approximately 6 OFCs will be administered to each participant
throughout the course of the study. Additionally, 10 participants will be enrolled as control
participants who will not receive any study therapy and will only have blood drawn at 3
visits throughout the course of the trial.

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