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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, double-blind, parallel group, placebo controlled
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: LY3650150
    Administered SC.
  • Drug: Standard therapy for INCS
    Administered as intranasal spray.
Experimental
Lebrikizumab Q2W/every 8 weeks (Q8W) 		Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
  • Drug: LY3650150
    Administered SC.
  • Drug: Standard therapy for INCS
    Administered as intranasal spray.
Placebo Comparator
Placebo Q2W/Q4W 		Placebo will be given as SC injection. Participants will receive background therapy with INCS.
  • Drug: Placebo
    Administered SC.
  • Drug: Standard therapy for INCS
    Administered as intranasal spray.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
205-934-7191

University of California, Irvine
Irvine, California 92697

DaVinci Research LLC
Roseville, California 95661
Contact:
916-374-6730

Colorado ENT & Allergy
Colorado Springs, Colorado 80923
Contact:
719-867-7804

University of South Florida
Tampa, Florida 33613
Contact:
813-631-4024

Treasure Valley Medical Research
Boise, Idaho 83706
Contact:
208-813-6505

Chicago ENT
Chicago, Illinois 60657
Contact:
773-289-1823

South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
Mandeville, Louisiana 70471

Chesapeake Clinical Research, Inc.
White Marsh, Maryland 21162
Contact:
410-931-1966 extension 103

Brigham and Women's Hospital
Boston, Massachusetts 02215
Contact:
617-732-6410

University of Missouri
Columbia, Missouri 65212
Contact:
573-882-7150

Madison ENT & Facial Plastic Surgery
New York, New York 10016
Contact:
551-655-4979

Equity Medical
The Bronx, New York 10455
Contact:
332-264-0155

Optimed Research, LTD
Columbus, Ohio 43235
Contact:
614-430-3030

Alina Clinical Trials
Dallas, Texas 75209
Contact:
214-363-1411

University of Texas Physicians Department of Otorhinolaryngology Clinc
Houston, Texas 77030
Contact:
713-704-4137

Ear Nose and Throat Associates of Texas PA
McKinney, Texas 75070-5735

Alamo ENT Associates
San Antonio, Texas 78258-3227
Contact:
210-545-0404

Eastern Virginia Medical School
Norfolk, Virginia 23507
Contact:
757-388-6238

The Medical College of Wisconsin
Milwaukee, Wisconsin 53226-3548
Contact:
414-805-3145,414-314-0430

More Details

NCT ID
NCT06338995
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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