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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Feb 2024

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At a glance

  • Drugs INT 301 (Primary)
  • Indications Peanut hypersensitivity
  • Focus Adverse reactions
  • Acronyms OMEGA
  • Sponsors Intrommune Therapeutics

    • Most Recent Events

    • 22 Feb 2024 According to an Intrommune Therapeutics media release, During the course of the trial, the United States Food and Drug Administration allowed amendments to the OMEGA Clinical Study protocol to determine the maximally tolerated dose and to allow the addition of a maintenance period which included a DBPCOFC at the end of the trial.
    • 25 Jul 2023 According to an Intrommune Therapeutics media release, the company announced that they have achieved Last Patient Last Visit in the Phase 1 OMEGA Clinical Study for patients with peanut allergy, and expect to present the full safety and efficacy results in the fourth quarter of this year
    • 25 Jul 2023 Status changed from active, no longer recruiting to completed.
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