Back to results

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

Primary Purpose

Peanut Allergy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

INT301

Placebo

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut allergy, Food allergy, Desensitization, Allergy Immunotherapy, OMIT, OIT, EPIT, SLIT, Oral Mucosal Immunotherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hudson-Essex Allergy
Weiss Medical

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active treatment

Placebo

Arm Description

INT301 dosing as determined by cohort assignment

Placebo as determined by cohort assignment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Dose amount tolerated without AEs requiring discontinuation for each participant.

Full Information

NCT ID

NCT04603300

First Posted

September 25, 2020

Last Updated

July 26, 2023

Sponsor

Intrommune Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04603300

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

May 15, 2021 (Actual)

Primary Completion Date

June 30, 2023 (Actual)

Study Completion Date

June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intrommune Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double blind is controlled by IWRS

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active treatment

Arm Type

Active Comparator

Arm Description

INT301 dosing as determined by cohort assignment

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo as determined by cohort assignment

Intervention Type

Drug

Intervention Name(s)

INT301

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Fully functional toothpaste containing no immunotherapy agents

Primary Outcome Measure Information:

Title

To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study.

Description

Percentage of participants able to consistently tolerate the protocol-specified highest dose; Incidence of systemic and non-systemic adverse reactions.

Time Frame

Forty-eight weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Forty-eight weeks

Title

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

Description

Dose amount tolerated without AEs requiring discontinuation for each participant.

Time Frame

Twenty-six weeks

Other Pre-specified Outcome Measures:

Title

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

Description

Change from baseline of peanut-specific IgG4, IgA, and IgE in study subjects (exploratory outcome)

Time Frame

Forty-eight weeks

Title

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

Description

Change from baseline of tolerated amount of peanut protein

Time Frame

Forty-eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Hudson-Essex Allergy

City

Belleville

State/Province

New Jersey

ZIP/Postal Code

07109

Country

United States

Facility Name

Weiss Medical

City

Riverdale

State/Province

New Jersey

ZIP/Postal Code

07457

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs