OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut

Study Overview
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Brief Summary
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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.

Official Title
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Oral Mucosal Escalation Goal Assessment (OMEGA) Study: A Randomized Placebo-Controlled Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut

Conditions
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Peanut Allergy

Intervention / Treatment
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* Drug: INT301
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active treatment<br>INT301 dosing as determined by cohort assignment | Drug: INT301<br>* INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste<br>|
| Placebo Comparator: Placebo<br>Placebo as determined by cohort assignment | Drug: Placebo<br>* Fully functional toothpaste containing no immunotherapy agents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study. | Percentage of participants able to consistently tolerate the protocol-specified highest dose; Incidence of systemic and non-systemic adverse reactions. | Forty-eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301. | 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. | Forty-eight weeks | 
| To determine the maximally tolerated dose during the up-dosing phase for adults. | Dose amount tolerated without AEs requiring discontinuation for each participant. | Twenty-six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanut allergy, Food allergy, Desensitization, Allergy Immunotherapy, OMIT, OIT, EPIT, SLIT, Oral Mucosal Immunotherapy