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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

In brief

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.

Key facts

Study ID: NCT06338995
Run by: Eli Lilly and Company
People needed: 510
Starts: 2024-04-29
Expected to finish: 2028-03-01
Last updated by the study team: 2026-08-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Alina Clinical Trials — Dallas, Texas, United States (enrolling)
CEMLO - Centro de Especialidades Médicas Lobos — Beunos Aires, Argentina (enrolling)
New York Allergy and Sinus Center — New York, New York, United States (enrolling)
Optimed Research, LTD — Columbus, Ohio, United States (enrolling)
Alamo ENT Associates — San Antonio, Texas, United States (enrolling)
The Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
Madison ENT & Facial Plastic Surgery — New York, New York, United States (enrolling)
DaVinci Research LLC — Roseville, California, United States (enrolling)
Equity Medical — The Bronx, New York, United States (enrolling)
Colorado ENT & Allergy — Colorado Springs, Colorado, United States (enrolling)
University of Texas Physicians Department of Otorhinolaryngology Clinc — Houston, Texas, United States (enrolling)
Ear Nose and Throat Associates of Texas PA — McKinney, Texas, United States (enrolling)
Eastern Virginia Medical School — Norfolk, Virginia, United States (enrolling)
University of South Florida — Tampa, Florida, United States (enrolling)
University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
Treasure Valley Medical Research — Boise, Idaho, United States (enrolling)
Entopy Research LLC — Chicago, Illinois, United States (enrolling)
Chicago ENT — Chicago, Illinois, United States (enrolling)
Breathe Clear Institute — Torrance, California, United States (enrolling)
South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS — Mandeville, Louisiana, United States (enrolling)
Chesapeake Clinical Research, Inc. — White Marsh, Maryland, United States (enrolling)
Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
University of Missouri — Columbia, Missouri, United States (enrolling)
University of California, Irvine — Irvine, California, United States (enrolling)
Policonsultorio CEPIR — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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