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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04603300
Recruitment Status : Completed
First Posted : October 26, 2020
Last Update Posted : July 28, 2023
Information provided by (Responsible Party):
Intrommune Therapeutics

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

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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
Actual Primary Completion Date : June 30, 2023
Actual Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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

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: Forty-eight 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04603300

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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
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Responsible Party: Intrommune Therapeutics Identifier: NCT04603300    
Other Study ID Numbers: INT301-101
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: July 28, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Allergy Immunotherapy
Oral Mucosal Immunotherapy
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate