Clinical trial NCT04603300: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peanut Allergy
Keywords: Peanut allergy
Food allergy
Desensitization
Allergy Immunotherapy
OMIT
OIT
EPIT
SLIT
Oral Mucosal Immunotherapy
Lead sponsor: Intrommune Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study.
timeFrame: Forty-eight weeks
Secondary outcomes:
measure: To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301.
timeFrame: Forty-eight weeks
measure: To determine the maximally tolerated dose during the up-dosing phase for adults.
timeFrame: Twenty-six weeks
Other outcomes:
measure: To explore changes in peanut-specific IgG4, IgA, and IgE levels in participants (exploratory outcome).
timeFrame: Forty-eight weeks
measure: To explore changes in patient response to oral food challenge pre-treatment and post treatment.
timeFrame: Forty-eight weeks
Locations:
city: Belleville
country: United States
facility: Hudson-Essex Allergy
state: New Jersey
city: Riverdale
country: United States
facility: Weiss Medical
state: New Jersey
Study officials:
References: