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Study Summary
This trial is for a new treatment of food allergies. The study will test if the treatment is safe and works for people with allergies to multiple foods, including peanuts. A total of 110 people will be in the study, and they will be given different doses of the treatment to see if it works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently receiving immunotherapy for allergies or venom.I have had issues like severe acid reflux, trouble swallowing, or unexplained stomach problems.You have a history of being allergic to peanuts and one or two other foods from a list that includes milk, almond, shellfish, fish, cashew, hazelnut, egg, walnut, sesame seeds, soy, and wheat. If you cannot eat both cooked and uncooked forms of milk and egg, it is considered an allergy.My asthma is severe, shown by hospital visits or specific breathing test results.My asthma is mild or moderate but hard to control.You have had a severe allergic reaction in the past that caused difficulty breathing or required a breathing tube, specifically to the foods used in this study.I am under 18 and have given my written agreement to participate.I am currently using or have used immunomodulator therapy.I am taking medication for blood pressure or heart conditions.I have a chronic disease that is stable and doesn't require frequent medication changes, excluding asthma, eczema, or hay fever.I have given my written consent to participate.I weigh less than 15 kg.I cannot tolerate treatments that involve antibodies.You cannot have taken any experimental drugs within the past 16 weeks before joining the study.I am between 4 and 55 years old.I have a history of heart disease or high blood pressure that is not well controlled.I have severe asthma.
- Group 1: Cohort B: Omalizumab/Dupilumab
- Group 2: Cohort C: Dupilumab
- Group 3: Cohort A: Omalizumab
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could I meet the standards to join this research project?
"This medical trial is looking for individuals with a peanut allergy whose ages range from 4 to 55 years old. A total of 110 participants will be recruited in order to meet the study's requirements."
Is the age limit for participation in this investigation greater than twenty-five years old?
"The lower age limit for this experimental protocol is 4 and the upper bound is 55."
Are there any US healthcare facilities conducting this research at present?
"The current trial is taking place across 4 distinctive sites, situated in San Diego, Los Angeles and Mountain View. There are also additional locations for participants to choose from that can reduce the need for extended travel times."
For which maladies is this remedy commonly prescribed?
"This treatment is popularly used to treat histamine h1 antagonists and those exhibiting non-sedating symptoms. It also appears effective at handling dermatitis, atopic allergies, chronic idiopathic urticaria as well as eosinophil issues."
What is the highest number of individuals that have been recruited for this medical experiment?
"Affirmative. The information stored on clinicaltrials.gov suggests that recruitment for this experiment is ongoing and began on the 5th of February 2020, with its most recent edit occurring on November 21st 2022. The research team seeks to recruit 110 people from 4 different locations."
Are there any vacancies in this clinical experiment for prospective participants?
"Confirmative. Clinicaltrials.gov verifies that enrollment for this clinical trial, initially published on February 5th 2020, is ongoing at the moment. 4 medical centres need to recruit 110 participants in total."
What potential risks could patients who take this treatment face?
"This trial has only recorded safety information, so it scored a 2 on our scale at Power. There is currently no evidence of efficacy associated with this treatment."
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