Salvage Peanut Oral Immunotherapy Study

Salvage Peanut Oral Immunotherapy Study is a single-arm, open label trial of peanut flour
with 6 month active treatment and 6 month follow-up on peanut food equivalent.

The first stage with 6 months treatment will involve approximately 3 months of build up phase
(desensitization) to a certain maintenance dose ( 300 mg peanut protein) then 3 months of
maintenance phase where subjects take daily 300 mg of peanut protein. After that the subjects
will start a food equivalent that contains 300 mg of peanut protein only.

During both phases subjects will be monitored for adverse events including gastrointestinal
side effects. They will also be monitored for any anaphylaxis or Epipen use. Data regarding
compliance with the drug will be collected as well.

Inclusion Criteria:

- Subjects who have completed an immunotherapy trial for peanut allergy within the last
6 months and are unable to tolerate ≥ 300mg of peanut.

- Age 1-65 years of either sex, any race, any ethnicity. Written informed consent from
patient or parent/guardian (if < 18 years) with participant's assent.

Exclusion Criteria:

- Current participation in an interventional study for peanut allergy

- History of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension,
or neurologic compromise (cyanosis or SpO2 ≤ 92% at any stage, hypotension, confusion,
collapse, loss of consciousness, or incontinence)

- Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease

- Severe asthma (2007 NHLBI Criteria Steps 5 or 6 , Appendix 2)

- Use of B blockers (oral), angiotensin-converting enzyme (ACE) inhibitors,
angiotensin-receptor blockers (ARB) or calcium channel blockers

- Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular,
hematologic, or pulmonary disease) which would put the subject at risk for induction
of severe food reactions.

Pregnancy or lactation.