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Omalizumab to Accelerate a Symptom-driven Multi-food OIT (BOOM)

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ClinicalTrials.gov Identifier: NCT04045301
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
The Hospital for Sick Children
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Information provided by (Responsible Party):
Philippe Bégin, St. Justine's Hospital

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 doses of omalizumab will be compared to placebo during an oral immunotherapy protocol for three simultaneous food allergens.

Condition or disease Intervention/treatment Phase
Food IgE-mediated Allergy Immunotherapy Omalizumab Physiological Effects of Drugs Biological: Omalizumab 16mg/kg Biological: Omalizumab 8mg/kg Biological: Placebo Other: Multi-food oral immunotherapy (OIT) Phase 2

Detailed Description:

This is a phase 2b, multi-center randomized controlled trial comparing 2 doses of omalizumab to placebo in subjects 6 to 25 years old with multiple food allergies undergoing a symptom-driven multi-food OIT protocol.

Subjects will undergo a screening period involving a DBPCFC to a mix of three allergens which will determine their eligibility and eliciting dose.

Eligible subjects will be randomized to one of 2 omalizumab dosages or placebo at a ratio of 2:2:1 for a total period of 20 weeks.

They will undergo initial food escalation (IFE) to determine their starting food treatment mix dose for three simultaneous food allergens after a pre-treatment period of 8 weeks with the study drug.

Subjects will undergo up-dosing OIT visits at the clinic every two weeks, until a maintenance dose of 1500mg of protein (500mg per food) is reached (primary endpoint).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 15 Months, Double-Blind, Randomized Controlled Trial Comparing 20 Weeks of Two Doses of Omalizumab to Placebo to Accelerate a Symptom-driven Oral Immunotherapy Schedule in Subjects Aged 6 to 25 Years With Multiple Food Allergies
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
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.

Biological: Omalizumab 16mg/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, for a total of 20 weeks including a taper period.

Other: Multi-food oral immunotherapy (OIT)
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.

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.

Biological: Omalizumab 8mg/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, for a total of 20 weeks including a taper period.

Other: Multi-food oral immunotherapy (OIT)
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.

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.

Biological: Placebo
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.

Other: Multi-food oral immunotherapy (OIT)
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.




Primary Outcome Measures :
  1. 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 ]
    Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein


Secondary Outcome Measures :
  1. Change in reactivity threshold to food treatment mix after pre-treatment with study drug. [ Time Frame: Measured 8 weeks after starting investigational product ]
    Measured as the amount of food allergen eliciting an objective allergic reaction on double-blinded oral food challenge or initial food escalation.

  2. Average up-dosing speed while on study drug. [ Time Frame: From week 0 to week 12 post IFE ]
    Average of (log of escalation %)/(days since last escalation) for all escalation visits while on study drug

  3. Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial. [ Time Frame: For one year following IFE ]
    AEs will be captured using the daily dosing diary throughout the trial, including during maintenance. Any systemic reaction having occurred since the last visit will be reviewed and graded by the investigator according to the CoFAR grading system.

  4. Rate of treatment failure [ Time Frame: At any time during the 12-month OIT phase ]
    Subject which stop daily ingestion of food treatment mix, prior to achieving study maintenance dose, for a period of 14 days or more



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male or female subjects 6 to 25 years old at screening visit.
  2. 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.
  3. Subjects currently following a strict avoidance of these three foods.
  4. Positive SPT with a largest wheal diameter ≥ 6 mm to all three foods.
  5. Food-specific IgE level greater than 15 kU/L for all three foods
  6. Positive DBPCFC to treatment food mix with an eliciting dose ≤ 300 mg of total food protein.
  7. Signed informed consent and assent.

Exclusion criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045301


Contacts
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Contact: Marie-Hélène Lavergne, B.Sc (514) 345-4931 ext 4180 marie-helene.lavergne@recherche-ste-justine.qc.ca
Contact: Isabelle Boisvert (514)-345-4931 ext 3200 isabelle.boisvert@recherche-ste-justine.qc.ca

Sponsors and Collaborators
Philippe Bégin
The Hospital for Sick Children
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Investigators
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Principal Investigator: Philippe Bégin, MD, PhD St. Justine's Hospital

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Responsible Party: Philippe Bégin, Principal Investigator, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT04045301     History of Changes
Other Study ID Numbers: ITO-OMA-2018-01
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Philippe Bégin, St. Justine's Hospital:
multi-food OIT
oral immunotherapy
omalizumab
symptom-driven protocol
double-Blind, randomized controlled trial
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Omalizumab
Immunologic Factors
Antibodies, Monoclonal
Physiological Effects of Drugs
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents