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Omalizumab for Chronic Urticaria
Study Summary
This trial will study why some people with Chronic Idiopathic Urticaria respond to omalizumab treatment while others do not, in hopes of better predicting who will respond to the treatment.
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.Side effects data
From 2016 Phase 4 trial • 17 Patients • NCT02023151Trial Design
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Who is running the clinical trial?
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- I have not used omalizumab in the last 3 months.I have not taken any steroids in the last month.I have severe asthma.I am starting Xolair for my severe hives that don't improve with antihistamines.I have not taken immunomodulatory drugs in the last month.My allergy symptoms are not managed by standard antihistamines.You have an illness that has not been treated.I have had hives for 6 weeks or more.My main symptom is frequent flushing.
- Group 1: Omalizumab
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is this research protocol accommodating individuals aged 25 and up?
"The requirements for this clinical trial stipulate that the ideal participants are aged between 18 and 75. Furthermore, there are 15 separate medical trials specifically tailored to patients under 18 years old and 46 studies with an upper age boundary of 65+."
What is the upper boundary for participants in this trial?
"Affirmative. According to clinicaltrials.gov, this medical investigation is actively recruiting patients and was initially announced on January 1st 2022 with a subsequent update occurring on March 23rd of the same year. 15 individuals are needed from one site for enrollment in the study."
What clinical indications can Omalizumab be utilized to treat?
"Omalizumab is prescribed for perennial aeroallergen reactivity, as well as symptoms that are not successfully managed with inhaled corticosteroids, histamine h1 antagonists, and moderate asthma."
Is this research endeavor actively recruiting participants?
"Yes, the data on clinicaltrials.gov concurs that this medical experiment is currently seeking to enroll patients. Initially posted on 1st January 2022 and recently revised on 23rd March of the same year, it requires 15 participants from a single center."
Has Omalizumab been investigated in other research studies?
"Currently, 6 clinical trials for Omalizumab are in the final phase of testing and 22 studies remain active. Despite being primarily based out of Los Angeles, California, there are 254 sites operating investigations into Omalizumab's potential therapeutic applications."
Has the FDA given its stamp of approval to Omalizumab?
"There are multiple studies in the public domain confirming Omalizumab's safety, thus it achieved a rating of 3."
How can I gain access to the clinical investigation?
"This clinical study seeks 15 persons aged 18-75 who are afflicted with chronic idiopathic urticaria and have not achieved relief from standard doses of antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5 mg daily)."
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