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Tests treatment safety and results for Allergies
Official title Omalizumab Weight-Based Dosing Efficacy Trial
ClinicalTrials.gov ID: NCT06943534
What this study is testing
What is 5mg/kg omalizumab injection?
5mg/kg omalizumab injection is an investigational medicine, being studied as a potential treatment for allergies.
Also referred to as Xolair.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 55
You may be able to join if
- 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)
You likely can't join if
- 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...
- Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing...
See the full eligibility 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)
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Chapel Hill, North Carolina, United States
- Dallas, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Chapel Hill, North Carolina, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.