Omalizumab to Accelerate a Symptom-driven Multi-food OIT

NCT04045301 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ITO-OMA-2018-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

multi-food OIT; oral immunotherapy; omalizumab; symptom-driven protocol; double-Blind, randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.

  Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein

  Assessed up to 52 weeks after IFE

Secondary Outcomes (4)

• Change in reactivity threshold to food treatment mix after pre-treatment with study drug.

  Measured 8 weeks after starting investigational product

• Average up-dosing speed while on study drug.

  From week 0 to week 12 post IFE

• Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial.

  For one year following IFE

• Rate of treatment failure

  At any time during the 12-month OIT phase

Study Arms (3)

Omalizumab 16 mg/kg

EXPERIMENTAL

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.

Biological: Omalizumab 16mg/kg; Other: Multi-food oral immunotherapy (OIT)

Omalizumab 8 mg/kg

EXPERIMENTAL

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.

Biological: Omalizumab 8mg/kg; Other: Multi-food oral immunotherapy (OIT)

Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo; Other: Multi-food oral immunotherapy (OIT)

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 16 mg/kg

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.

Omalizumab 8 mg/kg

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.

Placebo

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.

Omalizumab 16 mg/kg; Omalizumab 8 mg/kg; Placebo

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female subjects 6 to 25 years old at screening visit.
• History of IgE-mediated allergy to at least three foods within the following list: peanut, milk, egg, wheat, oat, soy, barley, rye, buckwheat, hazelnut, pecan, cashew, pistachio, almond, walnut and sesame.
• Subjects currently following a strict avoidance of these three foods.
• Positive SPT with a largest wheal diameter ≥ 6 mm to all three foods.
• Food-specific IgE level greater than 15 kU/L for all three foods
• Positive DBPCFC to treatment food mix with an eliciting dose ≤ 300 mg of total food protein.
• Signed informed consent and assent.

You may not qualify if:

• Subjects reacting objectively to the placebo during the screening DBPCFC.
• Severe asthma as defined by GINA 201948.
• Active or past confirmed eosinophilic oesophagitis.
• Subject currently under allergen immunotherapy.
• Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion.
• Subject/parent unwillingness to comply with study requirements.
• Subject unwillingness to ingest a daily food dose of up to 1500 mg of allergen protein.
• Inability to discontinue anti-histamine medication prior to study procedures.
• Known allergy to omalizumab or its excipients.
• Known allergy to components of the placebo food treatment mix that cannot be substituted without interfering with the blind (e.g.: dates, banana, chocolate syrup)
• Use of immunosuppression or immunomodulatory drug (including omalizumab) or food oral immunotherapy or investigational treatment or procedure within 1 year.
• Relative contraindication or inability to use epinephrine auto-injector.
• Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors.
• Pregnancy or lactation for the duration of the study.
• Any condition that is not compatible with the study treatment or procedures as per investigator judgment.

Sponsors & Collaborators

• Philippe Bégin: lead
• The Hospital for Sick Children: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator

Study Sites (3)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Langlois A, Lavergne MH, Leroux H, Killer K, Azzano P, Paradis L, Samaan K, Lacombe-Barrios J, Masse B, Des Roches A, Begin P. Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy. Allergy Asthma Clin Immunol. 2020 Apr 17;16:25. doi: 10.1186/s13223-020-00419-z. eCollection 2020.

  PMID: 32328115 DERIVED

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Philippe Bégin, MD, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: August 5, 2019
• Study Start: November 11, 2019
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)