Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT06338995

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

LY3650150

Placebo

Standard therapy for INCS

Study Details

Brief 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Study ID

NCT06338995

Start date

Apr 29, 2024

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

510 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)

Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).

Note: Enrollment of adolescents will be open-label, with all adolescents assigned to the lebrikizumab Q2W/Q4W treatment arm.

experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)

Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.

placebo comparator: Placebo Q2W/Q4W

Placebo will be given as SC injection. Participants will receive background therapy with INCS.

Interventions

LY3650150

Administered SC.

Placebo

Administered SC.

Standard therapy for INCS

Administered as intranasal spray.

Primary outcome measure

Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity [ Time Frame: Baseline, Week 24 ]
Mean CFBL in Endoscopic Nasal Polyp Score (NPS) [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

205-934-7191

Principal Investigator:

Do Yeon Cho

Novak Clinical Research - Tucson - North La Cholla Boulevard

Recruiting

Tucson, Arizona, United States, 85741

Contacts

520-909-2622

Principal Investigator:

Robert Dean

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Principal Investigator:

Naveen Bhandarkar

DaVinci Research LLC

Recruiting

Roseville, California, United States, 95661

Contacts

916-374-6730

Principal Investigator:

Randall Ow

Breathe Clear Institute

Recruiting

Torrance, California, United States, 90503

Contacts

310-372-0700

Principal Investigator:

Steven Davis

Colorado ENT & Allergy

Recruiting

Colorado Springs, Colorado, United States, 80923

Contacts

719-867-7804

Principal Investigator:

Bryan Davis

University of South Florida

Recruiting

Tampa, Florida, United States, 33613

Contacts

813-631-4024

Principal Investigator:

Seong Cho

Treasure Valley Medical Research

Recruiting

Boise, Idaho, United States, 83706

Contacts

208-813-6505

Principal Investigator:

Neetu Talreja

Entopy Research LLC

Recruiting

Chicago, Illinois, United States, 60616

Contacts

312-399-9337

Principal Investigator:

Pravin Muniyappa

Chicago ENT

Recruiting

Chicago, Illinois, United States, 60657

Contacts

773-289-1823

Principal Investigator:

Kirk Shepard

South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS

Recruiting

Mandeville, Louisiana, United States, 70471

Principal Investigator:

James Connolly

Chesapeake Clinical Research, Inc.

Recruiting

White Marsh, Maryland, United States, 21162

Contacts

410-931-1966 extension 103

Principal Investigator:

Sudhir Sekhsaria

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

617-732-6410

Principal Investigator:

Stella Lee

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

573-882-7150

Principal Investigator:

Christine Franzese

Madison ENT & Facial Plastic Surgery

Recruiting

New York, New York, United States, 10016

Contacts

551-655-4979

Principal Investigator:

Stacey Silvers

New York Allergy and Sinus Center

Recruiting

New York, New York, United States, 10016

Contacts

212-686-6321

Principal Investigator:

Robert Lin

Equity Medical

Recruiting

The Bronx, New York, United States, 10455

Contacts

332-264-0155

Principal Investigator:

Alissa McInerney

Optimed Research, LTD

Recruiting

Columbus, Ohio, United States, 43235

Contacts

614-430-3030

Principal Investigator:

Donald McNeil

Alina Clinical Trials

Recruiting

Dallas, Texas, United States, 75209

Contacts

214-363-1411

Principal Investigator:

Barbara Baxter

University of Texas Physicians Department of Otorhinolaryngology Clinc

Recruiting

Houston, Texas, United States, 77030

Contacts

713-704-4137

Principal Investigator:

Amber Luong

Ear Nose and Throat Associates of Texas PA

Recruiting

McKinney, Texas, United States, 75070-5735

Principal Investigator:

Dale Ehmer, Jr.

Alamo ENT Associates

Recruiting

San Antonio, Texas, United States, 78258-3227

Contacts

210-545-0404

Principal Investigator:

Jeffrey Rosenbloom

Eastern Virginia Medical School

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

757-388-6238

Principal Investigator:

Kent Lam

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226-3548

Contacts

414-805-3145,414-314-0430

Principal Investigator:

David Poetker

St. Joseph's Hospital

Recruiting

Ontario, Canada, N6A 4V2

Contacts

519-933-5483

Principal Investigator:

Leigh Sowerby

CSAC

Recruiting

Québec, Canada

Contacts

418-780-0881 x 229

Principal Investigator:

Remi Gagnon

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.