Peanut Allergy
Conditions
Keywords
Peanut allergy, Food allergy, Desensitization, Allergy Immunotherapy, OMIT, OIT, EPIT, SLIT, Oral Mucosal Immunotherapy
Brief summary
This is a phase 1, multi-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The treatment group will be blinded to the investigator, participants, and the Intrommune study team.
Interventions
DRUGINT301
INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste
DRUGPlacebo
Fully functional toothpaste containing no immunotherapy agents
Sponsors
Intrommune Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind is controlled by IWRS
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Participant must be 18-55 years of age inclusive, at the time of signing the informed consent. Female participants of childbearing potential or male participants with female partners of child-bearing potential must utilize highly effective birth control method(s) throughout the study and for 30 days after the final dose of study drug. Acceptable methods of contraception include: complete abstinence, male or female condoms with spermicide, oral or implanted contraceptives, or vasectomy. For female participants of child-bearing potential: Negative serum beta human chorionic gonadotrophin (HCG) pregnancy test at screening. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Meets at least one of the following conditions * Positive skin prick test (SPT) (wheal at least 3 mm greater than control) AND/OR Peanut specific IgE \>0.35 kU/L * Convincing clinical history of allergic reaction to peanut within 1 hour of ingestion for at least 3 months prior to screening. * Failed an oral food challenge (OFC) of \< 100mg of peanut protein at screening. * Participant willing and able to undergo the procedures required by the protocol, including, assessment completion, protocol compliance, and participation in the placebo dosing period(s).
Exclusion criteria
* History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence) * Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions * Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease * Psychiatric disorders that the Investigator believes will interfere with study assessments * Uncontrolled asthma, defined by at least one of the following conditions: * \- FEV1 \<80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) \<75% of predicted, with or without controller medications. * \- Inhaled corticosteroids (ICS) dosing of \>500mcg daily fluticasone (or equivalent ICS based on NHLBI dosing chart. * \- One hospitalization in the past year for asthma * \- An ER visit for asthma within six months prior to screening * Planned dental surgery during from screening until study exit * Moderate or advanced periodontal disease. * Current pregnancy or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study. | Forty-eight weeks | Percentage of participants able to consistently tolerate the protocol-specified highest dose; Incidence of systemic and non-systemic adverse reactions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301. | Forty-eight weeks | Number of participants requiring treatment for systemic reactions related to experimental treatment or placebo; Number of adverse events requiring treatment for systemic reactions related to experimental treatment or placebo; Adherence to study treatment. |
| To determine the maximally tolerated dose during the up-dosing phase for adults. | Twenty-six weeks | Dose amount tolerated without AEs requiring discontinuation for each participant. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To explore changes in peanut-specific IgG4, IgA, and IgE levels in participants (exploratory outcome). | Forty-eight weeks | Change from baseline of peanut-specific IgG4, IgA, and IgE in study subjects (exploratory outcome) |
| To explore changes in patient response to oral food challenge pre-treatment and post treatment. | Forty-eight weeks | Change from baseline of tolerated amount of peanut protein |
Countries
United States
Outcome results
None listed