Peanut AllergyPhase 1NCT04603300
OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
A Phase 1 study testing INT301 in people with Peanut Allergy, run by Intrommune Therapeutics at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- INT301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2021to 30 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- - 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hudson-Essex Allergy
Belleville, New Jersey, 07109
Weiss Medical
Riverdale, New Jersey, 07457
About this study
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
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
- Being tested
- INT301, Placebo
- Keywords
- Peanut allergy, Food allergy, Desensitization, Allergy Immunotherapy, OMIT, OIT, EPIT, SLIT, Oral Mucosal Immunotherapy
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INT301Drug
INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste
PlaceboDrug
Fully functional toothpaste containing no immunotherapy agents
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | INT301 dosing as determined by cohort assignment Receives: Drug: INT301 |
| Placebo | Placebo comparator | Placebo as determined by cohort assignment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Forty-eight weeks
Secondary outcomes (2)
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.
Measured: Forty-eight weeks
To determine the maximally tolerated dose during the up-dosing phase for adults.
Dose amount tolerated without AEs requiring discontinuation for each participant.
Measured: Twenty-six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start15 May 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intrommune Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603300
- Sponsor's protocol ID
- INT301-101
- Status last verified
- Jul 2023
- First submitted
- 25 Sep 2020
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39842774
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04603300
- Acronym / sponsor ID
- INT301-101
- Conditions
- Peanut Allergy
- Keywords
- Peanut allergy, Food allergy, Desensitization, Allergy Immunotherapy, OMIT, OIT, EPIT, SLIT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Intrommune TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Drug: INT301INT301 dosing as determined by cohort assignment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo as determined by cohort assignment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INT301INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste | Drug | Active treatment |
| PlaceboFully functional toothpaste containing no immunotherapy agents | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301.
Time frame: Forty-eight weeks
To determine the maximally tolerated dose during the up-dosing phase for adults.
Time frame: Twenty-six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 39842774Berger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INT301 in people with Peanut Allergy, run by Intrommune Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.