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

• ClinicalTrials.gov Identifier: NCT04603300
• Recruitment Status: Active, not recruiting
• First Posted: October 26, 2020
• Last Update Posted: October 18, 2022
• Sponsor: Intrommune Therapeutics
• Information provided by (Responsible Party): Intrommune Therapeutics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peanut Allergy	Drug: INT301; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blind is controlled by IWRS
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: May 15, 2021
• Estimated Primary Completion Date: July 30, 2023
• Estimated Study Completion Date: August 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study. [ Time Frame: Twenty-six weeks ]
   Percentage of participants able to consistently tolerate the protocol-specified highest dose; Incidence of systemic and non-systemic adverse reactions.

Secondary Outcome Measures :

1. To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301. [ Time Frame: 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.
2. To determine the maximally tolerated dose during the up-dosing phase for adults. [ Time Frame: Twenty-six weeks ]
   Dose amount tolerated without AEs requiring discontinuation for each participant.

Other Outcome Measures:

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New Jersey

Hudson-Essex Allergy

Belleville, New Jersey, United States, 07109

Weiss Medical

Riverdale, New Jersey, United States, 07457

Sponsors and Collaborators

Intrommune Therapeutics

More Information

• Responsible Party: Intrommune Therapeutics
• ClinicalTrials.gov Identifier: NCT04603300
• Other Study ID Numbers: INT301-101
• First Posted: October 26, 2020
• Last Update Posted: October 18, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Intrommune Therapeutics:

Peanut allergy; Food allergy; Desensitization; Allergy Immunotherapy; OMIT; OIT; EPIT; SLIT; Oral Mucosal Immunotherapy

Additional relevant MeSH terms:

Hypersensitivity; Peanut Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate