Your session is about to expire
← Back to Search
Dupilumab for Chronic Rhinosinusitis with Nasal Polyps
Study Summary
This trial will test whether Dupilumab can prevent recurrences of chronic rhinosinusitis with nasal polyps (CRSwNP) after surgery. Dupilumab is administered before and after surgery to reduce type 2 inflammation. The primary outcome is the absence of recurrence of mucosal oedema of the sinus cavity as assessed by endoscopy.
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
Find a Location
Who is running the clinical trial?
Media Library
- I am 18 years old or older.I haven't taken immune system drugs for my autoimmune disease in the last 2 months or 5 half-lives, whichever is longer.I have complications in my nose or sinuses, possibly due to a tumor or fungal infection.I haven't needed strong medication for an infection in the last 4 weeks.My liver is generally healthy and my ALT levels are not more than three times the normal limit.I have a condition like cystic fibrosis or similar.I have a history of weak immune system or serious infections.I have been diagnosed with or am at high risk for a parasitic infection.I have HIV or tested positive for HIV.I have active or untreated tuberculosis, or a history of incomplete TB treatment.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were fully treated.I have an active autoimmune disease or am on immunosuppressive therapy.I am scheduled for another surgery due to severe nasal polyps causing blockage, loss of smell, infections, or asthma issues.I started allergy shots less than 3 months ago or plan to start or change the dose soon.I have been on leukotriene modifiers for at least 30 days.I have not received any live vaccines in the last 4 weeks and do not plan to during the study.You have been treated with Dupilumab before.I have active hepatitis.I do not have any conditions that the medication's label warns against.I've had nose surgery that altered its structure, affecting nasal symptom evaluation.I do not have major nasal issues like severe polyps, deviated septum blocking a nostril, or ongoing infections.I have not had nose or sinus surgery in the last 6 months.Your blood test results at the beginning of the study show very high levels of creatine phosphokinase, very low levels of platelets, or very high levels of eosinophils.I have taken omalizumab within the last 130 days.I am a postmenopausal woman and do not need to use birth control.Women who can have children and have not had a confirmed negative pregnancy test, and are not using birth control or abstaining from sex as they normally would.I haven't taken any experimental antibody drugs recently.You have had a serious allergic reaction to any biologic drug in the past.You have a known or suspected problem with alcohol or drug abuse.I have had symptoms for at least 8 weeks.
- Group 1: Placebo
- Group 2: Dupilumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Are individuals still able to enroll in this research initiative?
"Clinicaltrials.gov data shows that recruitment is ongoing for this medical trial, which was first published on May 25th 2021 and most recently updated November 10th 2022."
Does this research offer an opportunity for elderly individuals to participate?
"In accordance with the eligibility criteria, individuals must be aged 18 or older and 70 or younger in order to qualify for this clinical trial."
Do I fulfill the prerequisites for this medical study?
"This clinical trial is searching for 36 adults aged 18-70 suffering from nasal polyps. Qualifying individuals must have experienced symptoms for 8 weeks or longer before V1, and must meet the standard criteria for revision surgery due to anosmia, recurrent infections, untolerable obstruction, or difficultly controlling asthma."
Has the Dupilumab drug been given clearance by the Food and Drug Administration?
"Dupilumab has been approved for use, making it eligible to receive a 3 on the safety scale. This is due to its Phase 4 trial status."
Are there any additional experiments that have utilized Dupilumab?
"Presently, 54 trials for Dupilumab are live with 13 of them attaining Phase 3. Most studies for this medication come from Palo Alto, California but it is being trialled in 2,608 different sites worldwide."
What is the uppermost cap on participation for this clinical trial?
"Affirmative. According to clinicaltrials.gov, this experiment initially posted on May 25th 2021 is presently recruiting individuals for participation. Recently updated on November 10th 2022, the trial requires 36 volunteers from a single medical site."
What maladies has Dupilumab demonstrated efficacy in treating?
"Dupilumab is commonly employed to alleviate nasal congestion, as well as various skin illnesses such as eczematous dermatitis and inadequately controlled atopic conditions."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger