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Clinical Trials in China / NCT06338995
Recruiting Phase 3

A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

NCT06338995 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2024-04-29
Last updated
2026-09-08

Condition(s) studied

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Investigational drug(s) / intervention(s)

LY3650150PlaceboStandard therapy for INCS

LY3650150: Administered SC.

Placebo: Administered SC.

Standard therapy for INCS: Administered as intranasal spray.

Study 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

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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. * Adolescent participants ≥12 to \<18 years of age and weighing ≥40 kg at time of Visit 1. 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). * 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: 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). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required. 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.

Primary outcome measure(s)

Trial sites (202)

FacilityCityRegionStatus
AllerVie Clinical Research Birmingham Alabama Not Yet Recruiting
University of Alabama at Birmingham Birmingham Alabama Recruiting
Medovation Research Huntsville Alabama Not Yet Recruiting
Novak Clinical Research - Tucson - North La Cholla Boulevard Tucson Arizona Recruiting
Keck Medicine of USC Arcadia California Not Yet Recruiting
University of California, Irvine Irvine California Recruiting
ADCRC La Mesa California Not Yet Recruiting
Ark Clinical Research Long Beach California Not Yet Recruiting
DaVinci Research LLC Roseville California Recruiting
Breathe Clear Institute Torrance California Recruiting
Colorado ENT & Allergy Colorado Springs Colorado Recruiting
Bioresearch Partner-Kendale Lakes Miami Florida Recruiting
Orlando ENT & Allergy Orlando Florida Not Yet Recruiting
NuLine Clinical Trial Center Pompano Beach Florida Not Yet Recruiting
University of South Florida Tampa Florida Recruiting
MJ Research Tampa Florida Not Yet Recruiting
Treasure Valley Medical Research Boise Idaho Recruiting
Entopy Research LLC Chicago Illinois Recruiting
Chicago ENT Chicago Illinois Recruiting
EMEDR Overland Park Kansas Recruiting
South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS Mandeville Louisiana Recruiting
Chesapeake Clinical Research, Inc. White Marsh Maryland Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
University of Missouri Columbia Missouri Recruiting
Washington University School of Medicine St Louis Missouri Not Yet Recruiting
Circuit Clinical/Mercer Allergy and Pulmonary Associates Hamilton New Jersey Not Yet Recruiting
Madison ENT & Facial Plastic Surgery New York New York Recruiting
New York Allergy and Sinus Center New York New York Recruiting
Equity Medical The Bronx New York Recruiting
UCMC Cincinnati Ohio Not Yet Recruiting
Optimed Research, LTD Columbus Ohio Recruiting
Charleston ENT Charleston South Carolina Not Yet Recruiting
Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery Charleston South Carolina Not Yet Recruiting
Alina Clinical Trials Dallas Texas Recruiting
UT Southwestern Medical Center Dallas Texas Not Yet Recruiting
University of Texas Physicians Department of Otorhinolaryngology Clinc Houston Texas Recruiting
Ear Nose and Throat Associates of Texas PA McKinney Texas Recruiting
Alamo ENT Associates San Antonio Texas Recruiting
Eastern Virginia Medical School Norfolk Virginia Recruiting
Richmond Ear Nose and Throat Richmond Virginia Not Yet Recruiting

+ 162 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06338995 on ClinicalTrials.gov ↗ ← All trials in China