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

NCT ID: NCT04603300

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active treatment

INT301 dosing as determined by cohort assignment

Group Type: ACTIVE_COMPARATOR

INT301

Intervention Type: DRUG

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

Placebo

Placebo as determined by cohort assignment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Fully functional toothpaste containing no immunotherapy agents

Interventions

INT301

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

Intervention Type: DRUG

Placebo

Fully functional toothpaste containing no immunotherapy agents

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intrommune Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hudson-Essex Allergy

Belleville, New Jersey, United States

Weiss Medical

Riverdale, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39842774 (View on PubMed)

Other Identifiers

INT301-101

Identifier Type: -

Identifier Source: org_study_id