Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Clinical Trial
Official title:
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Efficacy and Safety Study of Lebrikizumab/ LY3650150 in Adults With Chronic Rhinosinusitis With Nasal Polyps on a Background Therapy With Intranasal Corticosteroids
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.
| Status | Recruiting |
| Enrollment | 510 |
| Est. completion date | October 2026 |
| Est. primary completion date | November 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP). - Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both. - Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline. - Ongoing symptoms for at least 8 weeks prior to study entry (screening), including: 1. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and 2. At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea. - Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment. Exclusion Criteria: - Have received a dose of lebrikizumab. - Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period. - Allergen immunotherapy (subcutaneous immunotherapy [SCIT]/sublingual immunotherapy [SLIT]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening) or may require a dose change during study. - Prior or current biologic treatment for CRSwNP and/or asthma including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab. - Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit: 1. B cell-depleting biologics, including rituximab, within 6 months. 2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. 3. Systemic immunosuppressants within 4 weeks prior to baseline. - Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening - Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS - Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline: 1. Nasal septal deviation occluding at least one nostril. 2. Antrochoanal polyps. 3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection. 4. Ongoing rhinitis medicamentosa. 5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). 6. A nasal cavity tumor (malignant or benign). 7. Evidence of fungal rhinosinusitis. - Have anosmia from COVID or any reason other than CRSwNP. - Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening. - Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Pneumocare | Erpent | |
| Belgium | UZ Gent | Gent | Oost-Vlaanderen |
| Belgium | Cliniques Universitaires Saint-Luc Avenue Hippocrate 10 | Sint-Lambrechts-Woluwe | |
| Bulgaria | Multiprofile Hospital For Active Treatment Dr Tota Venkova A | Gabrovo | |
| Bulgaria | Medical Center Medconsult Pleven OOD | Pleven | |
| Bulgaria | Diagnostic-Consultative Centre Ascendent EOOD | Sofia | |
| Bulgaria | Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia, | Sofia | |
| Bulgaria | University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna | Sofia | |
| Bulgaria | Multiprofile Hospital for Active treatment Trakia EOOD | Zagora | |
| Italy | AOU Careggi- University of Florence | Florence | |
| Italy | Ospedale San Raffaele | Milano | Lombardia |
| Italy | AOU Federico II Via Pansini | Napoli | |
| Italy | Fondazione Policlinico A. Gemelli IRCCS | Rome | |
| Italy | ASST Brianza - Vimercate Hospital | Vimercate | |
| United States | Treasure Valley Medical Research | Boise | Idaho |
| United States | Colorado ENT & Allergy | Colorado Springs | Colorado |
| United States | South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS | Mandeville | Louisiana |
| United States | Ear Nose and Throat Associates of Texas PA | McKinney | Texas |
| United States | Richmond Ear Nose and Throat | Richmond | Virginia |
| United States | DaVinci Research LLC | Roseville | California |
| United States | Alamo ENT Associates | San Antonio | Texas |
| United States | Chesapeake Clinical Research, Inc. | White Marsh | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Belgium, Bulgaria, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity | NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary. | Baseline, Week 24 | |
| Primary | Mean CFBL in Endoscopic Nasal Polyp Score (NPS) | The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps. | Baseline, Week 24 | |
| Secondary | Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) | Central read on sinus computed tomography (CT) scans for the Lund Mackay score (LMK) will be performed. Review of the CT scans of the right and left frontal sinuses will include the use of a scoring system. The LMK scoring system is a 3-point grading scale where 0 = normal, 1 = partial opacification, and 2 = total opacification. The total score is the sum of the scores from each side and ranges from 0 to 24, where 0 indicates no disease and 24 indicates the most severe disease. | Baseline, Week 24 | |
| Secondary | Mean change in Forced Expiratory Volume in 1 Second (FEV1) | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. | Baseline, Week 24 | |
| Secondary | Mean CFBL in Severity of Loss of Smell | Participants will be asked about the severity of loss of smell using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of loss of smell, for the previous 24 hours. This assessment will be collected in the participant eDiary. | Baseline, Week 24 | |
| Secondary | Mean CFBL in Postnasal Drip | Postnasal drip is rated by study participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours. This assessment will be collected in the participant eDiary. | Baseline, Week 24 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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