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

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

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.

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Drug: INT301; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • Hudson-Essex Allergy
    • Riverdale, New Jersey, United States, 07457
      • Weiss Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore changes in peanut-specific IgG4, IgA, and IgE levels in participants (exploratory outcome).	Change from baseline of peanut-specific IgG4, IgA, and IgE in study subjects (exploratory outcome)	Forty-eight weeks
To explore changes in patient response to oral food challenge pre-treatment and post treatment.	Change from baseline of tolerated amount of peanut protein	Forty-eight weeks

Collaborators and Investigators

• Sponsor: Intrommune Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Peanut allergy; Desensitization; Food allergy; OIT; EPIT; SLIT; Allergy Immunotherapy; OMIT; Oral Mucosal Immunotherapy
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: INT301-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes