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
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment target
- 510
- Started
- 29 April 2024
- Main results due
- May 2027
- Study sites
- 202
- Registry updated
- 24 September 2026
Can you take part?
- Aged 12 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(202)
AllerVie Clinical Research
Birmingham, Alabama, United States
Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Medovation Research
Huntsville, Alabama, United States
Recruiting
Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson, Arizona, United States
Recruiting
Keck Medicine of USC
Arcadia, California, United States
Not yet recruiting
University of California, Irvine
Irvine, California, United States
Recruiting
ADCRC
La Mesa, California, United States
Not yet recruiting
Ark Clinical Research
Long Beach, California, United States
Not yet recruiting
DaVinci Research LLC
Roseville, California, United States
Recruiting
Breathe Clear Institute
Torrance, California, United States
Recruiting
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Recruiting
Bioresearch Partner-Kendale Lakes
Miami, Florida, United States
Recruiting
Orlando ENT & Allergy
Orlando, Florida, United States
Not yet recruiting
NuLine Clinical Trial Center
Pompano Beach, Florida, United States
Not yet recruiting
University of South Florida
Tampa, Florida, United States
Recruiting
MJ Research
Tampa, Florida, United States
Not yet recruiting
Treasure Valley Medical Research
Boise, Idaho, United States
Recruiting
Entopy Research LLC
Chicago, Illinois, United States
Recruiting
Chicago ENT
Chicago, Illinois, United States
Recruiting
EMEDR
Overland Park, Kansas, United States
Recruiting
South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
Mandeville, Louisiana, United States
Recruiting
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
University of Missouri
Columbia, Missouri, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Not yet recruiting
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton, New Jersey, United States
Not yet recruiting
Madison ENT & Facial Plastic Surgery
New York, New York, United States
Recruiting
New York Allergy and Sinus Center
New York, New York, United States
Recruiting
Equity Medical
The Bronx, New York, United States
Recruiting
UCMC
Cincinnati, Ohio, United States
Not yet recruiting
Optimed Research, LTD
Columbus, Ohio, United States
Recruiting
Charleston ENT
Charleston, South Carolina, United States
Not yet recruiting
Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery
Charleston, South Carolina, United States
Not yet recruiting
Alina Clinical Trials
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Not yet recruiting
University of Texas Physicians Department of Otorhinolaryngology Clinc
Houston, Texas, United States
Recruiting
Ear Nose and Throat Associates of Texas PA
McKinney, Texas, United States
Recruiting
Alamo ENT Associates
San Antonio, Texas, United States
Recruiting
Eastern Virginia Medical School
Norfolk, Virginia, United States
Recruiting
Richmond Ear Nose and Throat
Richmond, Virginia, United States
Not yet recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Recruiting
CEMLO - Centro de Especialidades Médicas Lobos
Beunos Aires, Argentina
Recruiting
Policonsultorio CEPIR
Buenos Aires, Argentina
Recruiting
Fundacion Respirar
Buenos Aires, Argentina
Recruiting
Fundacion CIDEA
Caba, Argentina
Recruiting
Centro de Investigaciones Clínicas - IESR - Rosario
Rosario, Argentina
Recruiting
Investigaciones en Patologías Respiratorias SRL
San Miguel de Tucumán, Argentina
Recruiting
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Argentina
Recruiting
Centro Respiratorio Infantil
Santa Fe, Argentina
Not yet recruiting
CARE - Centro de Alergia y Enfermedades Respiratorias
Villa Crespo, Argentina
Recruiting
Pneumocare
Erpent, Belgium
Recruiting
UZ Gent
Ghent, Belgium
Recruiting
Cliniques Universitaires Saint-Luc Avenue Hippocrate 10
Woluwe-Saint-Lambert, Belgium
Recruiting
Multiprofile Hospital For Active Treatment Dr Tota Venkova A
Gabrovo, Bulgaria
Recruiting
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria
Recruiting
Diagnostic-Consultative Centre Ascendent EOOD
Sofia, Bulgaria
Recruiting
Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia,
Sofia, Bulgaria
Not yet recruiting
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna
Sofia, Bulgaria
Recruiting
Multiprofile Hospital for Active treatment Trakia EOOD
Zagora, Bulgaria
Not yet recruiting
St. Joseph's Hospital
Ontario, Canada
Recruiting
Showing 60 of 202 sites — filter to narrow it down. 167 of the 202 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06338995. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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