Trial record 3 of 4750 for:    Open Studies | "Immune System"

A Phase 2 Randomized, Controlled, Blinded Study Omalizumab With Oral Food Immunotherapy in Children and Adults With Multiple Food Allergies

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02062814
First received: February 4, 2014
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

To develop a potentially curative therapy for patients with multi food allergy.We hypothesize that study subjects with multi food allergy who receive a combination of amalizumab and multi oral food therapy (OIT) can be rapidly desensitized and tolerate higher doses of food with fewer overall reactions than those who receive placebo and OIT.


Condition Intervention Phase
Immune System Disease
Drug: omalizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Controlled, Blinded Study in a Single Center Using Omalizumab With Oral Food Immunotherapy in Children and Adults With Multiple Food Allergies

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Number of omalizumbab treated subjects who have the ability to tolerate an oral dose of 4000mg of each food protein 6 weeks after discontinuing omalizumab. [ Time Frame: Week 25 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: omalizumab
45 pts will receive study drug. Study drug will be dosed per Genentech Global Dosing schedule.
Drug: omalizumab
Xolair will be randomized to 45 participants, and 15 pts will receive placebo.
Other Name: xolair
Placebo Comparator: placebo
15 pts will receive placebo study drug, 45 will receive omalizumbab
Drug: Placebo

Detailed Description:

Our phase 1 study results show that multiple oral immunotherapy given in the same method with omalizumab can be safe and show trends towards efficacy (attachment 3). Therefore, a phase 2 randomized, controlled, blinded study has been proposed to further test safety and efficacy in a larger group of subjects.

  Eligibility

Ages Eligible for Study:   4 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.

    2.Sensitivity to food allergen will be documented by a positive skin prick test result (see Appendix for details) or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.

    3.Sensitivity to food allergen based on a double-blind, placebo-controlled, oral food challenge (DBPCFC), at maximum of cumulative 182.7 mg of food allergen protein dose (see Appendix for details).

    4.All female subjects of child-bearing potential will be required to provide a human chorionic gonadotropin urine sample for pregnancy testing that must be negative 48 hours before being allowed to participate in the study.

    5.Subjects must plan to remain in the study area during the trial. 6.Subjects must be trained on the proper use of the EpiPen (see Appendix) to be allowed to enroll in the study.

    7.All female subjects of child-bearing potential must be compliant with a medically-approved method of contraception (please see Pregnancy section under Patient Disposition in this IND document)

Exclusion Criteria:

  • No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).

    1. Subjects with a total IgE at screening of >2,000 kU/L
    2. Previous reaction to omalizumab
    3. Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.
    4. Subjects with unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation or administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease).
    5. Subjects with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with or without controller medication (if able to perform the maneuver) at screening, an oral desensitization visit, or a food challenge visit.
    6. Subjects who are current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical).
    7. Subjects routinely using medication that could induce adverse gastrointestinal reactions during the study.
    8. Subjects refusing to sign the EpiPen Training Form (see Appendix).
    9. Women who are pregnant or breast feeding.
    10. Subjects with a history of oat allergy (since oat is the placebo agent in the DBPCFC, as per IND 14477) .
    11. Subjects with other food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study.
    12. Subjects with a diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062814

Contacts
Contact: Tina Dominguez, PA safar_inquiry@stanford.edu

Locations
United States, California
Stanford Alliance for Food Allergy Research Recruiting
Mountain View, California, United States, 94040
Principal Investigator: Kari Nadeau, MD PhD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kari Nadeau, MD PhD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02062814     History of Changes
Other Study ID Numbers: 01
Study First Received: February 4, 2014
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Multiple food allergies

Additional relevant MeSH terms:
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Hypersensitivity
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014