FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Study Purpose

This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 2 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study participants: 1. Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable; 2. Peanut allergic: participant must meet all of the following criteria to minimize the chance that the participant will develop natural tolerance to peanut over the course of the study: 1. Positive skin prick test (SPT) defined as ≥4 mm wheal greater than saline control) to peanut, 2. Positive peanut immunoglobulin E (IgE), ≥6 kUA/L, at Screening or within three months of Screening, determined by ImmunoCap, and 3. Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein. 3. Allergic to at least two of the six other foods (milk, egg, wheat, cashew, hazelnut, walnut): each participant must meet all of the following criteria for at least two of the six other foods to minimize the chance that the participant will develop natural tolerance to at least two of the six other foods over the course of the study: 1. Positive SPT (≥4 mm wheal) to food, 2. Positive food specific IgE (≥6 kUA/L) at Screening or within three months of Screening, determined by ImmunoCap, and 3. Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein. 4. With body weight (as measured at Screening) and total serum IgE level (as measured within three months of Screening) suitable for omalizumab dosing; 5. If female of child-bearing potential, must have a negative urine or serum pregnancy test; 6. For women of childbearing potential, must agree to:
  • - remain abstinent (refrain from heterosexual intercourse), - use acceptable contraceptive methods (barrier methods, - oral, injected, or implanted hormonal methods of contraception, or - other forms of hormonal contraception that have comparable efficacy), - during the treatment period and for 60 days after the last dose of study drug.
7. Plan to remain in the study area of a Consortium for Food Allergy Research (CoFAR) clinical research unit (CRU) during the trial; and 8. Be willing to be trained on the proper use of the Epinephrine Autoinjector.

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for enrollment as study participants: 1. Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol; 2. Clinically significant laboratory abnormalities at Screening; 3. Dose-limiting symptoms to the placebo portion of the Screening DBPCFC; 4. Sensitivity or suspected/known allergy to any ingredients (including excipients) of the
  • - active or placebo oral food challenge (OFC) material, - multi-allergen oral immunotherapy (OIT), or - drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
  • - Note: Guidance for determination of sensitivity to excipients will be detailed in the study's Manual of Procedures (MOP).
5. Poorly controlled atopic dermatitis (AD) at Screening, per the Principal Investigator's PI's) discretion; 6. Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria: 1. Global Initiative for Asthma (GINA) criteria regarding asthma control latest guidelines, 2. History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing, 3. Prior intubation/mechanical ventilation for asthma/wheezing, 4. One hospitalization or Emergency Department (ED) visit for asthma/wheezing within six months of Screening, 5. Forced expiratory volume in one second (FEV1) <80 percent of predicted or FEV1/forced vital capacity (FVC) <75 percent, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry), or 6. Inhaled corticosteroid (ICS) dosing of >500 mcg daily fluticasone (or equivalent ICS based on the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) dosing chart). 7. History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation; 8. Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of Screening; 9. Currently receiving oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical); 10. Past or current history of eosinophilic gastrointestinal (GI) disease within three years of Screening; 11. Past or current history of cancer, or currently being investigated for possible cancer; 12. Previous adverse reaction to omalizumab; 13. Past or current history of any immunotherapy to any of the foods being treated in this study (e.g., OIT, sublingual immunotherapy [SLIT], EPIT) within 12 months of Screening; 14. Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within six months of Screening; 15. Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Note: Individuals tolerating maintenance allergen immunotherapy can be enrolled; 16. Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs, food challenges, and initial dose escalation (IDE) Visits; 17. Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening; 18. Use of investigational drugs within 24 weeks of Screening; 19. Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab or placebo for omalizumab; 20. Has a first-degree relative already enrolled in the study; or 21. Past or current medical problems, history of other chronic diseases (other than asthma/wheezing, AD, or rhinitis) requiring therapy (e.g., heart disease, diabetes), findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which, in the opinion of the PI, may:
  • - pose additional risks from participation in the study, - may interfere with the participant's ability to comply with study requirements, or - may impact the quality or interpretation of the data obtained from the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03881696
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robert A. Wood, MDSharon Chinthrajah, MD
Principal Investigator Affiliation Department of Pediatrics at the Johns Hopkins University School of MedicineDepartment of Medicine, Stanford University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIHIndustryIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy, Multi-food Allergy
Study Website: View Trial Website
Additional Details

Food allergy affects about 15 million people in the United States. This includes 6 million children. The current treatment for food allergy is to avoid eating the foods that may cause an allergic reaction and have medications such as epinephrine (adrenaline) in case of a reaction. However, accidental exposures can be extremely difficult to avoid, particularly if you are allergic to multiple foods. The risks of accidental exposures and life-threatening reactions can place a large burden on patients and their families. Investigators in this study would like to learn if omalizumab injections alone or in combination with multi-allergen oral immunotherapy (OIT) will help people with multiple food allergies eat foods to which they are allergic. Oral means that you will take the food allergen (peanut and 2 other foods to which you are allergic) by mouth. If you are allergic to more than 3 foods, this study will only provide OIT for peanut and 2 other foods. There are 3 stages to the study: In Stage 1, investigators would like to learn: • If omalizumab stops or decreases allergic reactions to peanut and other common food allergens after taking it for a length of time. Stage 1 will also have an extra part so that 60 participants will receive omalizumab and everyone (the investigators conducting the research and study participants) will know it. This is why it is called the open label extension. This part of the study will assist investigators in learning if receiving omalizumab for a longer time may work better at decreasing allergic reactions. In Stage 2, investigators would like to learn: • How a short course of omalizumab combined with Multi-allergen OIT compares with a longer course of omalizumab in decreasing allergic reactions. In Stage 3, investigators would like to learn: • If, after participants stop both treatments, will they be able to eat the peanut and the 2 other foods in the form that is normally eaten. In all stages, investigators would like to learn:

  • - How safe and effective the treatments are and - How the OIT affects the immune system.
Participation will last up to 56 months (4 years and 8 months).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dallas, Texas

Status

Not yet recruiting

Address

University of Texas Southwestern Medical Center: Division of Allergy and Immunology

Dallas, Texas, 75390

Site Contact

Amy Arneson

amy.arneson@childrens.com

214-456-1438

Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Children's Hospital of Philadelphia: Division of Allergy and Immunology

Philadelphia, Pennsylvania, 19104

Site Contact

Noreen Dugan

DUGANN@EMAIL.CHOP.EDU

267-425-0100

Chapel Hill, North Carolina

Status

Not yet recruiting

Address

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

Chapel Hill, North Carolina, 27599-7000

Site Contact

Sarah Bennick, MSN,APRN,CPNP

sbennick@email.unc.edu

919-962-4409

New York, New York

Status

Not yet recruiting

Address

Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

New York, New York, 10029

Site Contact

Jaime Ross, RN, MSN

jaime.ross@mssm.edu

212-241-6577

Boston, Massachusetts

Status

Not yet recruiting

Address

Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit

Boston, Massachusetts, 02114

Site Contact

Cynthia Esteban

cesteban@mgh.harvard.edu

617-724-2081

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Children's Center: Department of Allergy & Immunology

Baltimore, Maryland, 21287

Site Contact

Maureen Jones

mjone241@JHMI.edu

410-502-1711

Atlanta, Georgia

Status

Not yet recruiting

Address

Emory University School of Medicine: Children's Healthcare of Atlanta Pediatrics

Atlanta, Georgia, 30307

Site Contact

Eric Hoar

eric.hoar@choa.org

404-785-1376

Denver, Colorado

Status

Recruiting

Address

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Denver, Colorado, 80206

Site Contact

Caroline Bronchick

bronchickc@njhealth.org

303-270-2207

Stanford, California

Status

Not yet recruiting

Address

Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research

Stanford, California, 94305

Site Contact

MacKenzie Cox

mkcox@stanford.edu

650-724-0293

Little Rock, Arkansas

Status

Not yet recruiting

Address

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

Little Rock, Arkansas, 72202

Site Contact

Darlene Robertson

LDRobertson@uams.edu

501-364-3749

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.