OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
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|ClinicalTrials.gov Identifier: NCT04603300|
Recruitment Status : Active, not recruiting
First Posted : October 26, 2020
Last Update Posted : October 18, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Drug: INT301 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind is controlled by IWRS|
|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|
Active Comparator: Active treatment
INT301 dosing as determined by cohort assignment
INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste
Placebo Comparator: Placebo
Placebo as determined by cohort assignment
Fully functional toothpaste containing no immunotherapy agents
- 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.
- 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.
- 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.
- 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)
- 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
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT04603300
|United States, New Jersey|
|Belleville, New Jersey, United States, 07109|
|Riverdale, New Jersey, United States, 07457|
|Responsible Party:||Intrommune Therapeutics|
|Other Study ID Numbers:||
|First Posted:||October 26, 2020 Key Record Dates|
|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|
Oral Mucosal Immunotherapy
Immune System Diseases
Nut and Peanut Hypersensitivity