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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Eli Lilly and Company
Where
Arcadia, Birmingham, Boise, Boston, Charleston, Chicago, Cincinnati, Colorado Springs, Columbia, Columbus, Dallas, Hamilton, Houston, Huntsville, Irvine, La Mesa, Long Beach, Mandeville, McKinney, Miami, Milwaukee, New York, Norfolk, Orlando, Overland Park, Pompano Beach, Richmond, Roseville, San Antonio, St Louis, Tampa, The Bronx, Torrance, Tucson, and White Marsh, United StatesSee the 41 sitesAlso in 19 other countries, 159 sites
Status
Recruiting
Phase
Phase 3
People taking part
510 people, planned
Started
29 Apr 2024
Expected to end
Mar 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LY3650150
  • Placebo
  • Standard therapy for INCS
Record updated
4 November 2026

Who can take part

Age
12 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 in United States

Also in 19 other countries, 159 sites

  • Keck Medicine of USCArcadia, United StatesContact: Kevin Hur (principal investigator)Not yet recruiting
  • AllerVie Clinical ResearchBirmingham, United StatesContact: Weily Soong (principal investigator)Not yet recruiting
  • University of Alabama at BirminghamBirmingham, United StatesContact: Do Yeon Cho (principal investigator)Taking people
  • Treasure Valley Medical ResearchBoise, United StatesContact: Neetu Talreja (principal investigator)Taking people
  • Brigham and Women's HospitalBoston, United StatesContact: Stella Lee (principal investigator)Taking people
  • Charleston ENTCharleston, United StatesContact: Thomas Murphy (principal investigator)Taking people
  • Medical University of South Carolina- Department of Otolaryngology and Head and Neck SurgeryCharleston, United StatesContact: Rodney Schlosser (principal investigator)Not yet recruiting
  • Chicago ENTChicago, United StatesContact: Kirk Shepard (principal investigator)Taking people
  • Entopy Research LLCChicago, United StatesContact: Pravin Muniyappa (principal investigator)Taking people
  • UCMCCincinnati, United StatesContact: Ahmad Sedaghat (principal investigator)Not yet recruiting
  • Colorado ENT & AllergyColorado Springs, United StatesContact: Bryan Davis (principal investigator)Taking people
  • University of MissouriColumbia, United StatesContact: Christine Franzese (principal investigator)Taking people
  • Optimed Research, LTDColumbus, United StatesContact: Donald McNeil (principal investigator)Taking people
  • Alina clinical trialsDallas, United StatesContact: Barbara Baxter (principal investigator)Taking people
  • UT Southwestern Medical CenterDallas, United StatesContact: Sei Chung (principal investigator)Not yet recruiting
  • Circuit Clinical/Mercer Allergy and Pulmonary AssociatesHamilton, United StatesContact: Peter Ricketti (principal investigator)Not yet recruiting
  • University of Texas Physicians Department of Otorhinolaryngology ClincHouston, United StatesContact: Amber Luong (principal investigator)Taking people
  • Medovation ResearchHuntsville, United StatesContact: William McFeely (principal investigator)Taking people
  • University of California, IrvineIrvine, United StatesContact: Naveen Bhandarkar (principal investigator)Taking people
  • ADCRCLa Mesa, United StatesContact: Geoffrey Pitzer (principal investigator)Taking people
  • Ark Clinical ResearchLong Beach, United StatesContact: Kenneth Kim (principal investigator)Taking people
  • South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDSMandeville, United StatesContact: James Connolly (principal investigator)Taking people
  • Ear Nose and Throat Associates of Texas PAMcKinney, United StatesContact: Dale Ehmer, Jr. (principal investigator)Taking people
  • Bioresearch Partner-Kendale LakesMiami, United StatesContact: Octavio Carreno (principal investigator)Taking people
  • The Medical College of WisconsinMilwaukee, United StatesContact: David Poetker (principal investigator)Taking people
  • Madison ENT & Facial Plastic SurgeryNew York, United StatesContact: Stacey Silvers (principal investigator)Taking people
  • New York Allergy and Sinus CenterNew York, United StatesContact: Robert Lin (principal investigator)Taking people
  • Eastern Virginia Medical SchoolNorfolk, United StatesContact: Kent Lam (principal investigator)Taking people
  • Orlando ENT & AllergyOrlando, United StatesContact: Cecelia Damask (principal investigator)Not yet recruiting
  • EMEDROverland Park, United StatesContact: Steven Ellis (principal investigator)Taking people
  • NuLine Clinical Trial CenterPompano Beach, United StatesContact: Jacqueline DeNobriga (principal investigator)Not yet recruiting
  • Richmond Ear Nose and ThroatRichmond, United StatesContact: Michael Armstrong (principal investigator)Not yet recruiting
  • DaVinci Research LLCRoseville, United StatesContact: Randall Ow (principal investigator)Taking people
  • Alamo ENT AssociatesSan Antonio, United StatesContact: Jeffrey Rosenbloom (principal investigator)Taking people
  • Washington University School of MedicineSt Louis, United StatesContact: H James Wedner (principal investigator)Not yet recruiting
  • MJ ResearchTampa, United StatesContact: Mario Gonzalez-Fernandez (principal investigator)Not yet recruiting
  • University of South FloridaTampa, United StatesContact: Seong Cho (principal investigator)Taking people
  • Equity MedicalThe Bronx, United StatesContact: Alissa McInerney (principal investigator)Taking people
  • Breathe Clear InstituteTorrance, United StatesContact: Steven Davis (principal investigator)Taking people
  • Novak Clinical Research - Tucson - North La Cholla BoulevardTucson, United StatesContact: Robert Dean (principal investigator)Taking people
  • Chesapeake Clinical Research, Inc.White Marsh, United StatesContact: Sudhir Sekhsaria (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)Treatment being tested

    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.

    Treatment: LY3650150 and Standard therapy for INCS

  • Lebrikizumab Q2W/every 8 weeks (Q8W)Treatment being tested

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

    Treatment: LY3650150 and Standard therapy for INCS

  • Placebo Q2W/Q4WPlacebo, for comparison

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

    Treatment: Placebo and Standard therapy for INCS

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Record updated
4 November 2026
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) (NCT06338995) – Frontlight Research