Clinical Trials

Omalizumab Weight-Based Dosing Efficacy Trial

Study Purpose

This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.

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	1 Year - 55 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk) - Positive food specific IgE (≥2.0 kUA/L) to at least two of the relevant foods.

- A positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food.

(If meeting above criteria):

- Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)
Exclusion Criteria:
- Weight >80 kg at time of screening.

- Clinically significant laboratory abnormalities at screening.

- Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab.

- Poorly controlled or severe asthma/wheezing at screening.

- History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, PICU admission f for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation.

- 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.

- Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers.

- Past or current history of eosinophilic gastrointestinal disease within three years of screening.

- Past or current history of cancer, or currently being investigated for possible cancer.

- Past or current history of any food immunotherapy (e.g., OIT, SLIT, EPIT) within 6 months of screening.

- Treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening.

- Inability to discontinue antihistamines for minimum wash-out periods required for SPTs or OFCs.

- Pregnant or breastfeeding or intending to become pregnant during the study.

- Evidence of clinically significant chronic disease.

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.	NCT06943534
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 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massachusetts General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Wayne Shreffler, MD, PhD
Principal Investigator Affiliation	Massachusetts General Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergies, Food Allergy

Additional Details

This research is being conducted to assess the safety and effectiveness of omalizumab for food allergies dosed differently from what is currently FDA approved. The study hypothesizes the current way of dosing omalizumab may not work well for all patients with food allergy and it unnecessarily excludes some individuals with very high allergic antibody (IgE) who may benefit. This study will include subjects regardless of IgE level. One of the goals is to learn more about how safe and effective Omalizumab is for people with these high IgE levels, since this has not been fully studied before.

Arms & Interventions

Arms

Active Comparator: Patients Receiving 5mg/kg of omalizumab

Participants randomized to this arm will receive a does of 5mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.

Active Comparator: Patients Receiving 15mg/kg of omalizumab

Participants randomized to this arm will receive a does of 15mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.

Interventions

Drug: - 5mg/kg omalizumab injection

5mg/kg of omalizumab

Drug: - 15mg/kg omalizumab injection

15mg/kg of omalizumab

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.

Chapel Hill, North Carolina

Status

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Lauren Herlihy

[email protected]

617-643-8683

University of Texas Southwestern, Dallas, Texas

Status

Address

University of Texas Southwestern

Dallas, Texas, 75390