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

NCT04603300 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: INT301-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Peanut Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301.

  Forty-eight weeks

• To determine the maximally tolerated dose during the up-dosing phase for adults.

  Twenty-six weeks

Other Outcomes (2)

• To explore changes in peanut-specific IgG4, IgA, and IgE levels in participants (exploratory outcome).

  Forty-eight weeks

• To explore changes in patient response to oral food challenge pre-treatment and post treatment.

  Forty-eight weeks

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

INT301 dosing as determined by cohort assignment

Drug: INT301

Placebo

PLACEBO COMPARATOR

Placebo as determined by cohort assignment

Drug: Placebo

Interventions

INT301 DRUG

INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste

Active treatment

Placebo DRUG

Fully functional toothpaste containing no immunotherapy agents

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Intrommune Therapeutics: lead

Study Sites (2)

Hudson-Essex Allergy

Belleville, New Jersey, 07109, United States

Location

Weiss Medical

Riverdale, New Jersey, 07457, United States

Location

Related Publications (1)

• Berger WE, Faris N, Weinstein M, Wilding GE, Berglund E. Randomized, placebo-controlled, phase 1 safety study of oral mucosal immunotherapy in adults with peanut allergy. Ann Allergy Asthma Immunol. 2025 Apr;134(4):448-456. doi: 10.1016/j.anai.2025.01.013. Epub 2025 Jan 20.

  PMID: 39842774 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind is controlled by IWRS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 26, 2020
• Study Start: May 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)