RecruitingPhase 3NCT06338995
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/LY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids
Sponsor
Eli Lilly and Company
Enrollment
510 participants
Start Date
Apr 29, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.
Eligibility
Min Age: 12 Years
Inclusion Criteria8
- 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:
- 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
- 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.
- Adolescent participants ≥12 to \<18 years of age and weighing ≥40 kg at time of Visit 1.
Exclusion Criteria21
- 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).
- Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.
- Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:
- B cell-depleting biologics, including rituximab, within 6 months.
- other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
- 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:
- Nasal septal deviation occluding at least one nostril.
- Antrochoanal polyps.
- Acute sinusitis, acute nasal infection, or acute upper respiratory infection.
- Ongoing rhinitis medicamentosa.
- Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.
- A nasal cavity tumor (malignant or benign).
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGLY3650150
Administered SC.
DRUGPlacebo
Administered SC.
DRUGStandard therapy for INCS
Administered as intranasal spray.
Locations(190)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06338995
Related Trials
ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
NCT073996656 locations
Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy
NCT071255861 location
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
NCT0710725660 locations
Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
NCT067760421 location
Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
NCT066832618 locations