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Clinical Study Using Biologics to Improve Multi OIT Outcomes

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ClinicalTrials.gov Identifier: NCT03679676
Recruitment Status : Not yet recruiting
First Posted : September 20, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
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 3-5% of adults. This is a prospective Phase 2, single-center, multi-allergen OIT in participants with proven allergies to up to 3 different foods in which one must be a peanut. The total of participants in the clinical study will be 160, ages 4 to 21 years with a history of multiple food allergies of up to 3 different foods including peanut. An additional 20 multi-food allergic participants and 20 non-allergic controls that will not undergo OIT, will be followed to help interpret immune mechanisms of OIT. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive at or before the 100 mg (144 mg cumulative) a 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 up to 3 different foods in which one must be peanut. The total population will be 160 participants, ages 6 to 21 years that present with a history of multiple food allergies of up to 3 different foods including peanut, food-allergen (FA)-specific IgE levels, and positive skin prick test (SPT). An additional 20 matched multi-food allergic participants and 20 non-allergic controls that will not undergo OIT, will be followed to help interpret immune mechanisms of OIT.

Enrolled participants must react positively during DBPCFCs at or before the 100 mg (144 mg cumulative) dosing level of FA proteins of up to 3 allergens in which one must be a peanut.

There will be four study cohorts: Cohort A (40 participants) will be treated with omalizumab for 8 weeks, followed by an additional 16 weeks of treatment with omalizumab. Cohort B (40 participants) will be treated with omalizumab for 8 weeks, followed by 16 weeks of treatment with dupilumab. Cohort C (40 participants) will be treated with dupilumab for 8 weeks, followed by an additional 16 weeks of treatment with dupilumab. Cohort D (40 participants) will be treated with placebo for 24 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 up to 3 different foods in which one must be peanut. Our intent to treat population will be 160 participants, ages 4 to 21 years with a history of multiple food allergies of up to 3 different foods including peanut. An additional 20 multi-food allergic participants and 20 non-allergic controls that will not undergo OIT, will be followed to help interpret immune mechanisms of OIT. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive at or before the 100 mg (144 mg cumulative) a 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
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : November 30, 2020

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 an additional 16 weeks of treatment with omalizumab.
Drug: Omalizumab
To compare immunological responses after 24 weeks of treatment with omalizumab, dupilumab, omalizumab dupilumab combination, or placebo.

Cohort B: Omalizumab/Dupilumab
Participants will be treated with omalizumab for 8 weeks, followed by 16 weeks of treatment with dupilumab.
Drug: Omalizumab
To compare immunological responses after 24 weeks of treatment with omalizumab, dupilumab, omalizumab dupilumab combination, or placebo.

Drug: Dupilumab
To compare immunological responses after 24 weeks of treatment with omalizumab, dupilumab, omalizumab dupilumab combination, or placebo.

Cohort C: Dupilumab
Participants will be treated with dupilumab for 8 weeks, followed by an additional 16 weeks of treatment with dupilumab.
Drug: Dupilumab
To compare immunological responses after 24 weeks of treatment with omalizumab, dupilumab, omalizumab dupilumab combination, or placebo.

Placebo Comparator: Cohort D: Placebo
Participants will be treated with placebo for 24 weeks.
Other: Placebo
To compare immunological responses after 24 weeks of treatment with omalizumab, dupilumab, omalizumab dupilumab combination, or placebo.




Primary Outcome Measures :
  1. Successful food challenges to two or more FA at week 38 between Cohort B and Cohort D [ Time Frame: Thirty Eight weeks ]
    The difference in proportion of participants who pass DBPCFCs to a cumulative dose of >/= 2000 mg of at least two or more FA proteins at week 38 between Cohort B and Cohort D.


Secondary Outcome Measures :
  1. Successful food challenges to two or more FA at week at week 38. [ Time Frame: Thirty Eight weeks ]
    Proportion of participants among cohorts A, B, C and D who successfully pass DBPCFCs to a cumulative dose of >/= 2000 mg protein of at least two FAs in their OIT at week 38.

  2. Successful food challenge to one FA at week 38. [ Time Frame: Thirty Eight weeks ]
    The proportion of participants among different cohorts who successfully pass DBPCFCs to a cumulative dose of >/= 2000 mg of at least one FA protein in their OIT at week 38.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 through 21 years (inclusive).
  • Clinical history of peanut allergy and 1-2 additional foods from the following foods: milk, almond, cashew, hazelnut, pecan, walnut, sesame seeds, soy, and wheat.
  • 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 PRACTALL DBPCFC to small doses of food defined as a dose of =/<144 mg food protein.
  • No clinical reaction observed during the placebo (oat) challenge.
  • Written informed consent from adult participants.
  • Written informed consent from parent/guardian for minor participants.
  • Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements).
  • Use of effective birth control by female participants of childbearing potential.

Exclusion Criteria:

  • History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension.
  • History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening.
  • 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 (2007 NHLBI Criteria Steps 5 or 6) Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4), if uncontrolled or difficult to control.
  • Inability to tolerate biological (antibody) therapies.
  • Use of immunomodulator therapy (not including corticosteroids).

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: Sharon Chinthrajah, M.D. 650-723-5227 snpcenterallergy_scheduler@stanford.edu
Contact: Andres Alvarez Pinzon, M.D.,Ph.D., MHA 650-962-4438 aalvarezpinzon@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Kari C Nadeau, M.D., Ph.D. Sean N Parker Center for Allergy and Asthma Center at Stanford

Additional Information:
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Responsible Party: Sharon Chinthrajah, Medical Director, Clinical Research Unit, Stanford University
ClinicalTrials.gov Identifier: NCT03679676     History of Changes
Other Study ID Numbers: Pending
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 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
Keywords provided by 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
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs