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Rituximab + Omalizumab for Bullous Pemphigoid
Study Summary
This trial is testing whether combining two drugs, rituximab and omalizumab, can help achieve sustained complete remission for patients with bullous pemphigoid (BP) who haven't responded well to rituximab alone.
- Bullous Pemphigoid
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have been diagnosed with a specific autoimmune blistering disease called mucous membrane pemphigoid or another similar condition.You have had an allergic reaction or bad side effects from humanized or murine monoclonal antibodies, or you are known to be hypersensitive to any ingredient in rituximab or omalizumab.You have received a live or weakened vaccine within the past 28 days before starting rituximab treatment.You have a serious ongoing illness that has not responded well to at least one cycle of rituximab treatment.
- Group 1: Rituximab combined with Omalizumab
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 clinical trial open to people who are under the age of 60?
"The age range for qualified applicants in this clinical trial is 18 to 90 years old. There are 62 trials for minors and 413 trials focused on geriatric patients."
What are the most frequently occurring side effects of Rituximab and Omalizumab in patients?
"There is both evidence of efficacy and rounds of data affirming safety, so this Rituximab-Omalizumab combination received a 3 on our team's 1-3 scale."
Are patients being actively sought for this experiment?
"Unfortunately, this specific trial is no longer recruiting patients. The study was originally posted on May 25th, 2023 but the most recent update was on September 1st, 2022. There are currently 442 clinical trials enrolling patients that involve Rituximab combined with Omalizumab and 13 other trials for patients with bullous pemphigoid (bp)."
How many participants are being recruited for this experiment?
"Bullous pemphigoid (bp) patients are not being recruited for this trial at the moment. This study was first advertised on May 25th, 2023 and has not been updated since September 1st, 2022. There are presently 13 studies actively looking for patients with bullous pemphigoid (bp) and 442 trials for Rituximab combined with Omalizumab enrolling patients."
What do Rituximab and Omalizumab work together to target?
"Rituximab in combination with Omalizumab is commonly used to treat diffuse large b-cell lymphoma (dlbcl), but this treatment method can also target other conditions like histamine h1 antagonists, non-sedating, b-cell lymphomas, and polyangium."
Are there any specific demographics that are being targeted for this research?
"The ideal candidate for this study is somebody 18 to 90 years old that has been diagnosed with bullous pemphigoid."
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