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Clinical Study Using Biologics to Improve Multi OIT Outcomes

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ClinicalTrials.gov Identifier: NCT03679676
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
R. Sharon Chinthrajah, Stanford University

Brief Summary:
Food allergy (FA) is a serious public health concern that causes potentially-life threatening reactions in affected patients. The prevalence of food allergy in the United States (U.S.) has increased substantially and now affects 15 million patients:4-8% of children (6 million children, 30% with multiple food allergies) and about 9% of adults. This is a prospective Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be a peanut. The total of participants in the clinical study will be 110, ages 6 to 25 years with a history of multiple food allergies of 2 to 3 different foods including peanut. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive during the Double-blind Placebo-controlled Food challenge (DBPCFC) at or before the 300 mg (444 mg cumulative) dosing level of FA proteins.

Condition or disease Intervention/treatment Phase
Hypersensitivity Food Allergy Hypersensitivity, Food Peanut Hypersensitivity Peanut Allergy Drug: Omalizumab Drug: Dupilumab Other: Placebo Phase 2

Detailed Description:

This is a prospective Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The total population will be 110 participants, ages 6 to 25 years that present with a history of multiple food allergies of 2 or 3 different foods including peanut, food-allergen (FA)-specific IgE levels, and positive skin prick test (SPT).

Enrolled participants must react positively during DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins of 2 or 3 allergens in which one must be a peanut.

There will be three study cohorts, all will be double blinded:

Cohort A (50 participants) will be treated with omalizumab for 8 weeks followed by 24 weeks of treatment with placebo. Cohort B (50 participants) will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab. Cohort C (10 participants) will be treated with placebo for 8 weeks followed by 24 weeks treatment with dupilumab. All cohorts will receive multifood allergen oral immunotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective Phase 2, single-center, multi-allergen OIT in participants with proven allergies to 2 or 3 different foods in which one must be peanut. Our intent to treat population will be 110 participants, ages 6 to 21 years with a history of multiple food allergies of 2 or 3 different foods including peanut. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive during the DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Randomized Controlled Trial Using Biologics to Improve Multi OIT Outcomes
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Cohort A: Omalizumab
Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with placebo
Drug: Omalizumab
Omalizumab is injected every 2 to 4 weeks
Other Name: Xolair

Other: Placebo
Placebo is injected every 2 to 4 weeks

Cohort B: Omalizumab/Dupilumab
Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.
Drug: Omalizumab
Omalizumab is injected every 2 to 4 weeks
Other Name: Xolair

Drug: Dupilumab

Dupilumab is injected every 2 weeks

combination, or placebo.

Other Name: Dupixent

Cohort C: Dupilumab
Participants will be treated with placebo for 8 weeks, followed by 24 weeks of treatment with dupilumab.
Drug: Dupilumab

Dupilumab is injected every 2 weeks

combination, or placebo.

Other Name: Dupixent

Other: Placebo
Placebo is injected every 2 to 4 weeks




Primary Outcome Measures :
  1. The success rates of passing a peanut Food Challenge (FC) [ Time Frame: 44 weeks ]
    Success is defined as passing a cumulative dose of >=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B.

  2. The success rates of passing a FC to peanut and at least one other FA [ Time Frame: 44 weeks ]
    Success is defined as passing a cumulative dose of >=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B.

  3. The success rates of passing a FC to peanut and two other FAs [ Time Frame: 44 weeks ]
    Success is defined as passing a cumulative dose of >=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B.


Secondary Outcome Measures :
  1. Proportion of participants who successfully pass DBPCFCs to a cumulative dose of >=1,043 mg protein to 1, 2, or 3 FAs when applicable at week 44 [ Time Frame: 44 weeks ]
  2. Proportion of participants who successfully pass DBPCFCs to a cumulative dose of ≥2,043 mg to 1, 2, or 3 FAs when applicable at week 32 [ Time Frame: 32 weeks ]
  3. Proportion of participants who pass DBPCFCs for each FA at a cumulative dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at week 32 and/or week 44. [ Time Frame: week 32 and/or 44 ]
  4. Proportion of participants who have a 10-fold change in the cumulative tolerance dose for each FA at weeks 32 and/or week 44, compared to baseline [ Time Frame: Baseline and week 32 and/or 44 ]


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:

  • Age 6 through 25 years (inclusive).
  • Clinical history of peanut allergy and 1 or 2 additional foods from the following foods: milk, almond, shellfish, fish, cashew, hazelnut, egg, walnut, sesame seeds, soy, and wheat. Allergy to milk and egg is defined as unable to tolerate both cooked and uncooked forms.
  • Positive allergy test determined by:
  • ImmunoCAP serum IgE level >4 kUA/L for each allergen within the past 12 months OR
  • Skin prick test (SPT) ≥6 mm wheal diameter to each allergen.
  • A clinical reaction during a DBPCFC to small doses of food defined as a cumulative dose of =/<444 mg food protein.
  • No clinical reaction observed during the placebo (oat) challenge.
  • Subject and/or parent guardian must be able to understand and provide informed consent.
  • Written informed consent from adult participants.
  • Written informed consent from parent/guardian for minor participants.
  • Written assent from minor participants as appropriate (e.g., at and above the age of 7 years).
  • Use of effective birth control by female participants of childbearing potential.

Exclusion Criteria:

  • History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension.
  • Individuals less than 20 kg in weight at start of the study
  • History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation.
  • History of chronic disease (other than asthma, atopic dermatitis or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen.
  • History of eosinophilic esophagitis (EoE), another eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology.
  • Severe asthma (NAEPP EPR-3 Medication Criteria Steps 5 or 6)
  • Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if uncontrolled or difficult to control.
  • Uncontrolled asthma as evidenced by:

    • FEV1 < 80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) < 75% of predicted, with or without controller medications (only for age 6 or greater and able to do spirometry reliably. If unable to do spirometry, PEF of >80% is acceptable) or;
    • One overnight admission to a hospital in the past year for asthma or;
    • Emergency room (ER) visit for asthma within six months prior to screening.
  • Inability to tolerate biological (antibody) therapies.
  • Use of immunomodulator therapy (not including corticosteroids).
  • Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers.
  • Current participation or within the last 4 months in any other interventional study.
  • Pregnancy or lactation.
  • Allergy to oat (placebo in DBPCFC).
  • Use of investigational drugs within 16 weeks of participation.
  • In build up phase of immunotherapy for aeroallergens or venom.

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): NCT03679676


Contacts
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Contact: MacKenzie Cox, BS 650-521-7237 snpcenterallergy_scheduler@stanford.edu

Locations
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United States, California
University of California Los Angeles (UCLA) Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Stacey Zedeck, RN    310-993-4878    SSkura@mednet.ucla.edu   
Principal Investigator: Maria Garcia-Lloret, MD         
Sean N. Parker Center for Allergy & Asthma Research at Stanford University Recruiting
Mountain View, California, United States, 94040
Contact: Mackenzie Cox, BS    650-521-7237    snpcenterallergy_scheduler@stanford.edu   
University of California San Diego (UCSD) Not yet recruiting
San Diego, California, United States, 92123
Contact: Kayleigh Prowse, MSN    858-576-1700 ext 224213    KProwse@rchsd.org   
Contact: Susan Laubach, MD    858-576-1700 ext 224213    slaubach@rchsd.org   
Principal Investigator: Stephanie Leonard, MD         
Sub-Investigator: Susan Laubach, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Rebecca S Chinthrajah, M.D. Sean N Parker Center for Allergy and Asthma Center at Stanford
Additional Information:
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Responsible Party: R. Sharon Chinthrajah, Medical Director, Clinical Research Unit, Stanford University
ClinicalTrials.gov Identifier: NCT03679676    
Other Study ID Numbers: IRB-47935
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
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
Keywords provided by R. Sharon Chinthrajah, Stanford University:
Food Allergy
Hypersensitivity, Peanut
Food Hypersensitivity
Allergy, Food
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Nut and Peanut Hypersensitivity
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents