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Dupilumab for Severe Eosinophilic Chronic Sinusitis
Study Summary
This trial will test how well dupilumab works in patients with severe eosinophilic chronic rhinosinusitis who haven't responded to other treatments and have significant disease involving more than two sinuses bilaterally.
- Severe Eosinophilic Chronic Sinusitis
Timeline
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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- The person has bilateral sinusitis, meaning that they have infection in both of their sinuses, and it has not been cured by using a corticosteroid treatment for at least 8 weeks.You have received an experimental monoclonal antibody within the past 6 months or within five times its half-life if its duration is unknown.You have previously participated in a clinical trial for a medication called dupilumab.The patient's LMK-CT score is ≥ 10 (out of a maximum of 24) at screening.You should not be taking leukotriene antagonists/modifiers, unless you have been consistently taking them for at least 30 days before the screening.You have at least two of these symptoms before being screened: stuffy nose, runny nose, facial pain or pressure, or loss of smell.You have chronic sinusitis with nasal polyps.You have a runny nose or mucus dripping from the back of your nose.
- Group 1: Placebo
- Group 2: Active drug
- 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
Has Active drug obtained clearance from the Food and Drug Administration?
"The Active drug has been given a score of 2 on our metric scale since it is still in its Phase 2 trial with limited data supporting safety and no efficacy."
What is the capacity of this research study?
"Affirmative. Per the information on clinicaltrials.gov, this study is in need of participants and was initially announced on December 17th 2020 with a recent update occurring on November 14th 2022. The trial requires 30 individuals to be recruited from one single medical facility."
Has this kind of research been attempted before?
"Currently, 49 distinct studies for Active drug are live across 436 cities in 43 countries. The initial trials began back in 2015 with Sanofi as the sponser and 880 participants completing Phase 3 of the approval process. Subsequently, 18356 additional clinical evaluations have been completed since then."
Is this experiment accepting participants at the moment?
"According to clinicaltrials.gov, this trial is actively seeking participants as of November 14th 2022 - the date of its most recent update. Originally posted on December 17th 2020, the study aims to recruit a yet unspecified number of patients."
Have investigators carried out any earlier investigations of Active drug?
"Currently, there are 49 clinical trials assessing the efficacy of Active drug with 13 in their final phase. Though Palo Alto, California is conducting several studies on this medication, it can be found at 2602 unique sites around the world."
For what conditions is Active drug typically used?
"Active drug is frequently employed when treating dermatitis, atopic and other ailments such as corticosteroid resistance, eosinophil-mediated reactions, and asthma."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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