Omalizumab to Accelerate a Symptom-driven Multi-food OIT

Sponsor
Philippe Bégin
Study ID
NCT04045301
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Food IgE-mediated Allergy
  • Immunotherapy
  • Omalizumab
  • Physiological Effects of Drugs

Eligibility Criteria

Sex
ALL
Age
6 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab 16mg/kg — BIOLOGICAL
    Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
  • Omalizumab 8mg/kg — BIOLOGICAL
    Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
  • Placebo — BIOLOGICAL
    Participants will receive placebo for 8 weeks prior to the initiation of oral immunotherapy and 12 weeks after for a total of 20 weeks including a taper period.
  • Multi-food oral immunotherapy (OIT) — OTHER
    Multi-food oral immunotherapy will be conducted to a mix of three foods. It will be started 8 weeks after study drug with an initial food escalation. Participants will undergo biweekly increase until they tolerate a maintenance dose of 1500 mg (500 mg per food) of food protein.

Study Details

This study will determine the dose-related efficacy of a 20-week treatment of omalizumab started 8 weeks before the onset of a symptom-driven multi-food oral immunotherapy (OIT) protocol at decreasing time to OIT maintenance dose. Two dosages of omalizumab will be compared to placebo during an oral immunotherapy protocol for three simultaneous food allergens.

Key Dates

Start date
Nov 11, 2019
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab 16 mg/kg
    Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
  • Experimental: Omalizumab 8 mg/kg
    Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
  • Placebo Comparator: Placebo
    Participants will receive placebo doses for 20 weeks. The doses will be injected every 2 or 4 weeks depending on the weight of the participant. Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.

Primary Outcome Measure

To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol. [ Time Frame: Assessed up to 52 weeks after IFE ]

Related Studies