NCT04603300 is a Phase 1 clinical trial of INT301 in Peanut Allergy, sponsored by Intrommune Therapeutics.

Who is sponsoring NCT04603300?

NCT04603300 is sponsored by Intrommune Therapeutics.

What drugs are being tested in NCT04603300?

Interventions in NCT04603300: INT301, Placebo.

What condition does NCT04603300 study?

NCT04603300 studies Peanut Allergy.

Is NCT04603300 still recruiting?

NCT04603300 is currently completed. Last updated 28 July 2023.

Last reviewed 2023-07-28 · How we verify

NCT04603300

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 28 July 2023

What this trial tests

Phase 1 trial testing INT301 in Peanut Allergy in 32 participants. Completed in 30 June 2023.

Timeline

15 May 2021

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Intrommune Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	32
Start date	15 May 2021
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	2 locations across United States

Drugs / interventions tested

INT301 — full drug profile →
Placebo

Conditions studied

Peanut Allergy — all drugs for Peanut Allergy →

Sponsor

Intrommune Therapeutics — full company profile →

Who can join

Adults 18 to 55, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Feast for thought: A comprehensive review of food allergy 2021-2023.
Bartha I, Almulhem N, Santos AF. · · 2024 · cited 74× · PMID 38101757 · DOI 10.1016/j.jaci.2023.11.918
Novel Approaches in the Inhibition of IgE-Induced Mast Cell Reactivity in Food Allergy.
Tontini C, Bulfone-Paus S. · · 2021 · cited 24× · PMID 34456900 · DOI 10.3389/fimmu.2021.613461
Moving Beyond Desensitization to Tolerance in Food Allergy.
Flom JD, Shreffler WG, Perrett KP. · · 2025 · cited 7× · PMID 40010566 · DOI 10.1016/j.jaip.2025.02.014
Update on clinical research for food allergy treatment.
Fowler J, Lieberman J. · · 2023 · cited 4× · PMID 37520143 · DOI 10.3389/falgy.2023.1154541
The Etiology of IgE-Mediated Food Allergy: Potential Therapeutics and Challenges.
Carnazza M, Werner R, Tiwari RK, Geliebter J, et al · · 2025 · cited 3× · PMID 40004029 · DOI 10.3390/ijms26041563
Randomized, placebo-controlled, phase 1 safety study of oral mucosal immunotherapy in adults with peanut allergy.
Berger WE, Faris N, Weinstein M, Wilding GE, et al · · 2025 · cited 2× · PMID 39842774 · DOI 10.1016/j.anai.2025.01.013

Verify or expand the search:

Other recruiting trials for Peanut Allergy

Currently open trials in the same condition.

NCT07349212 — UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies · Phase 1, PHASE2 · recruiting
NCT05695261 — Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients · Phase 2 · recruiting
NCT05503446 — Using Commonly Available Food Products To Treat Food Allergy · NA · active not recruiting
NCT05667610 — Immune-supportive Diet and Gut Permeability in Allergic Children · NA · recruiting
NCT06256146 — Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04603300 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Intrommune Therapeutics
Last refreshed: 28 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04603300.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing