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Monoclonal Antibodies
Dupilumab for Chronic Sinusitis (Liberty CRSsNP Trial)
Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 64
Awards & highlights
Liberty CRSsNP Trial Summary
This trial is testing the efficacy of dupilumab in reducing symptoms of chronic sinusitis with nasal polyps. The trial will compare dupilumab to placebo in terms of sinus opacification, total symptom score, and quality of life at 24 and 52 weeks. The trial will also assess the safety and tolerability of dupilumab compared to placebo.
Who is the study for?
This trial is for individuals at least 12 years old with a body weight of ≥30 kg, suffering from chronic sinusitis and nasal congestion for over 12 weeks. They must have specific symptoms and CT scan results showing sinus inflammation. Excluded are those with recent surgery or certain treatments, active infections, history of cancer within 5 years (with exceptions), known allergies to dupilumab, unstable doses of nasal steroids, or severe other illnesses.Check my eligibility
What is being tested?
The trial tests the effectiveness and safety of Dupilumab in reducing sinus opacification seen on CT scans by week 24 compared to a placebo. It also assesses symptom scores, drug tolerability, how the body processes the drug (pharmacokinetics), and immune response to Dupilumab over time.See study design
What are the potential side effects?
Potential side effects include allergic reactions to Dupilumab's ingredients, issues related to immune system changes such as increased infection risk or inflammation in various organs due to its action on the immune system.
Liberty CRSsNP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 64
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 64
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using the Lund Mackay (LMK) score in the dupilumab group only
Secondary outcome measures
Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using the LMK score
Change from baseline to Week 24 in sTSS
Dupilumab concentration in serum
+2 moreSide effects data
From 2021 Phase 4 trial • 52 Patients • NCT0444741712%
Ecchymosis
8%
Limb Injury
8%
Myalgia
8%
Medical Device Site Haemorrhage
4%
Abdominal Pain
4%
Upper Respiratory Tract Infection
4%
Medical Device Site Pain
4%
Anxiety
4%
Dental Restoration Failure
4%
Petechiae
4%
Medical Device Site Urticaria
4%
Back Pain
4%
Pain In Extremity
4%
Covid-19
4%
Food Poisoning
4%
Tooth Abscess
4%
Dermatitis
4%
Medical Device Site Erythema
4%
Blood Pressure Abnormal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteer
Atopic Dermatitis Patients
Liberty CRSsNP Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Part A and B: DupilumabExperimental Treatment1 Intervention
Dupilumab administered every 2 weeks.
Group II: Part A and B: Matching placeboPlacebo Group1 Intervention
Placebo administered every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab SAR231893
2021
Completed Phase 4
~2070
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,409 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,776 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,228 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- For Part B of the study, you must be at least 12 years old or the legal age for teenagers in the country where the study is taking place when you sign the informed consent form.You weigh at least 30 kilograms.You have had a stuffy or blocked nose for at least 12 weeks before the first visit and have a stuffy nose score of 2 or more at both the first and second visits.You have received intravenous immunoglobulin therapy or plasmapheresis within 30 days before the screening visit.You have had cancer in the past 5 years, except for some specific types that were completely treated.You have had a severe allergic reaction to dupilumab or any of its ingredients in the past.You have participated in a previous dupilumab clinical trial, used commercially available dupilumab within the past year, or stopped using dupilumab because of a negative reaction.You have taken medication to treat inflammatory or autoimmune diseases within a certain amount of time before the start of the study.You have taken any experimental medication within 5 half-lives before the start of the study.You have started allergy shots in the last 3 months or plan to start or change the dose during the study.You have a tumor in your nasal cavity.You need to have inflammation in both of your sinuses and a certain level of opacification in the ethmoid sinuses in a CT scan to be included in the study.You have a suspected or confirmed serious fungal infection in your sinuses.You currently have active tuberculosis or a type of bacterial infection called non-tuberculous mycobacterial infection.You have nasal conditions or diseases that could affect the study results at the first visit or for the main evaluation.You must have a score of 5 or higher for symptoms like nasal congestion, runny nose, and facial pain/pressure at the first and second visits.You have been using an inconsistent dose of nasal corticosteroid spray in the 4 weeks before the screening visit.You have received omalizumab treatment within the 4 months before the first study visit.You had spinal cord stimulation treatment during the screening period.You are using certain types of nasal sprays or treatments during the screening period.Your ability to breathe out forcefully is less than half of what is expected for someone your age and size.You have had sinus surgery for chronic rhinosinusitis or have been treated with systemic corticosteroids for chronic rhinosinusitis in the past 2 years, or you cannot take systemic corticosteroids.You currently have a parasitic infection or are at high risk of getting one.You are taking certain medications that affect leukotrienes, unless you have been taking them continuously for at least 30 days before the start of the study.You have been experiencing loss of smell and runny nose for at least 12 weeks before the first visit.
Research Study Groups:
This trial has the following groups:- Group 1: Part A and B: Dupilumab
- Group 2: Part A and B: Matching placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there several research facilities within this city that are conducting this trial?
"There are a total of 24 clinical trial sites running this study, with 3 in Canada (Montreal, Quebec and Trois-Rivieres) and the rest being located elsewhere."
Answered by AI
What is the record for Dupilumab SAR231893 in terms of adverse effects?
"Dupilumab SAR231893 is a medication that has gone through multiple rounds of safety testing and has been shown to be effective, so it received a score of 3."
Answered by AI
Have there been other similar medical trials in the past?
"As of right now, 52 clinical trials involving Dupilumab SAR231893 are ongoing in 455 cities and 43 countries. The first such study began in 2015. That particular trial, which was sponsored by Sanofi, had 880 participants and reached Phase 3 approval. In the years since 2015, a total of 18319 have completed their clinical trials."
Answered by AI
What goals does this research team hope to accomplish with this experiment?
"The primary outcome of this 24-week study will be changes in sinus opacification, as measured by CT scan and the Lund Mackay score. The secondary outcomes include rhinosinusitis severity VAS scores, normalized enrichment scores for relative change from baseline in type 2 inflammation transcriptome signature, and dupilumab concentration in serum."
Answered by AI
Are there other drugs that have been trialed with Dupilumab SAR231893?
"Dupilumab SAR231893 was first studied in 2015 at the Regeneron Investigational Site. As of now, 18319 studies have been completed with 52 trials actively recruiting patients. Many of these locations for recruitment are in Montréal and Texas."
Answered by AI
Are participants being signed up for this research right now?
"The clinical trial appears to be ongoing, as the most recent update on clinicaltrials.gov was posted 5/3/2022. The study was originally advertised on 12/2/2020."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Investigational Site Number 1240001
What portion of applicants met pre-screening criteria?
Met criteria
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