Chronic Sinusitis Clinical Trial
Official title:
Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP): a Randomized Double Blind Placebo Controlled Phase II Study
The overarching objective of this study is to determine the clinical effectiveness of dupilumab for the treatment of CRS that includes several potential disease endotypes with the exclusion of the nasal polyp cluster that has previously been determined. The additional information gained from secondary and exploratory outcomes will help provide important insight for applied research studies and may also provide practical guidance to clinicians on how to select patients for treatment.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 15, 2024 |
Est. primary completion date | October 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age 18-75 with history of chronic sinusitis without polyps - SNOT-22 score of at least 30 at baseline - Bilateral Lund-Mackay CT score 4 or more and/or MLK endoscopy score 4 or more - Blood eosinophil count of at least 300/ul and/or SPT positive to at least 5/30 allergens, or eosinophil less than 300/ul and SPT negative (Th2 low group). - Prior oral steroid or antibiotic use is acceptable but not required for entry - Informed Consent - Effective birth control (with <1% failure rate), post menopausal or documented abstinence - Women =50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. - All male subjects who are sexually active must agree to use an acceptable method of contraception (condom or vasectomy) from V1-V16 Exclusion Criteria: - Immunosuppression other than oral steroids in the past 3 months - History of nasal polyps within the past 3 years or noted at screening by CT or endoscopy - Acute sinusitis at the time of entry - Acute fungal sinusitis at the time of entry - Uncontrolled asthma - Cystic fibrosis - Primary immune deficiency including CVID - Other; serious concomitant illness or sinus disease that the investigator determines to disqualify - A history of known immunodeficiency disorder including HIV - History of hepatitis B or C - Primary ciliary dyskinesia (PCD) - Use of any biologic medication within the last 5 months or 5 half-lives whichever is longer - Receipt of any investigational non-biologic within 5 half-lives prior to visit 0 - Receipt of immunoglobulin or blood products within 30 days prior to V1 - Scheduled sinus surgery - Significant structural abnormalities or severe septal deviation - Symptomatic or untreated life threatening cardiopulmonary disorders - History of cancer not in remission at least 5 years prior to the date informed consent - Subjects who are febrile (=38°C; =100.4°F); - Untreated helminth parasitic infection within 24 weeks prior to informed consent - Pregnant or nursing - Any other medical illness that precludes study involvement - History of anaphylaxis to any biologic therapy or vaccine - The following medications are excluded: - Any type of anti-interleukin therapy (e.g. Omalizumab, benralizumab, dupilumab mepolizumab, reslizumab, lebrikizumab etc.) within the last 5 months or 5 half-lives whichever is longer - Receipt of any investigational non-biologic within 30 days or 5 half-lives prior to visit 0, whichever is longer. - Immunosuppressive medications such as methotrexate, azathioprine, cyclosporine, tacrolimus - Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained. - Daily high dose aspirin greater than 81mg daily - Allergen Immunotherapy during build-up phase during the last three months - Other medications that could interfere with the action of dupilumab or suppress eosinophils |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SNOT-22 | Sino-Nasal Outcome Test (SNOT-22) survey score after six months treatment (range 0-110). Higher score means worse symptoms. | Every two weeks for six months | |
Secondary | Mini-RQLQ | Mini-RQLQ (Rhinoconjunctivitis Quality of Life) validated survey (0-84). Higher score means worse symptoms. | Every two weeks for six months | |
Secondary | UPSIT | University of Pennsylvania Smell Identification Test (UPSIT) smell test (0-40). Higher score means better sense of smell. | Every two weeks for six months | |
Secondary | Rescue medication | Rescue medication use of corticosteroids. Specifically, prednisone mg use total over six month period. | Every two weeks for six months | |
Secondary | CT Score | Sinus CT Lund-Mackay (LM) score (0-24). Higher score means larger polyps. | Once at screening and then at six month final visit | |
Secondary | Rhinoscopy Score | Rhinoscopy modified Lund-Kennedy (MLK) score (0-12). Higher score means worse sinus disease. | Once at screening and then at six month final visit | |
Secondary | Drop out rate rate | Number of patients who leave the study. Individual participants will be considered to have dropped out if they leave the study for any reason during the six month treatment period. A total count will be collected over the entire study length estimated to be three years. This number will be divided by the total enrollment number to determine the rate of drop out. | Continuous during entire length of study which is three years. | |
Secondary | Adverse event rate | Significant Adverse Reactions (SAE). Individual participants will be monitored for serious adverse events during the six month treatment period. A total count will be collected over the entire study length estimated to be three years. This number will be divided by the total enrollment number to determine the rate of adverse events. | Continuous during entire length of study which is three years. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02266810 -
Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus
|
Phase 3 | |
Completed |
NCT01706484 -
Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis
|
Phase 3 | |
Completed |
NCT01197612 -
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
|
Phase 3 | |
Completed |
NCT04163978 -
Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)
|
Phase 2 | |
Completed |
NCT04418622 -
Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis
|
||
Not yet recruiting |
NCT06070311 -
Wound Healing After Endoscopic Sinus Surgery
|
N/A | |
Not yet recruiting |
NCT05454163 -
Post-radiotherapy Rhinosinusitis in Children
|
||
Withdrawn |
NCT01185808 -
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
|
N/A | |
Completed |
NCT01700725 -
Gulf War Illness Nasal Irrigation Study
|
Phase 2 | |
Withdrawn |
NCT00671281 -
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery
|
N/A | |
Completed |
NCT00447837 -
Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
|
Phase 2 | |
Completed |
NCT05035654 -
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
|
Phase 2 | |
Completed |
NCT02562924 -
The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
|
N/A | |
Completed |
NCT01007799 -
Vitamin D for Chronic Sinusitis
|
N/A | |
Completed |
NCT03358329 -
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
|
Phase 3 | |
Withdrawn |
NCT02981017 -
Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure
|
N/A | |
Completed |
NCT04041609 -
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
|
Phase 2 | |
Recruiting |
NCT01854619 -
Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT00924404 -
Xylitol Versus Saline in Chronic Sinusitis
|
N/A | |
Not yet recruiting |
NCT03903432 -
The Feasibility of Using MRI During ESS
|
N/A |