Standard therapy for INCS: Administered as intranasal spray.
Study 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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
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.
Primary outcome measure(s)
Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity — Baseline, Week 24 NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary.
Mean CFBL in Endoscopic Nasal Polyp Score (NPS) — Baseline, Week 24 The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps.
Trial sites (202)
Facility
City
Region
Status
AllerVie Clinical Research
Birmingham
Alabama
Not Yet Recruiting
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
Medovation Research
Huntsville
Alabama
Not Yet Recruiting
Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson
Arizona
Recruiting
Keck Medicine of USC
Arcadia
California
Not Yet Recruiting
University of California, Irvine
Irvine
California
Recruiting
ADCRC
La Mesa
California
Not Yet Recruiting
Ark Clinical Research
Long Beach
California
Not Yet Recruiting
DaVinci Research LLC
Roseville
California
Recruiting
Breathe Clear Institute
Torrance
California
Recruiting
Colorado ENT & Allergy
Colorado Springs
Colorado
Recruiting
Bioresearch Partner-Kendale Lakes
Miami
Florida
Recruiting
Orlando ENT & Allergy
Orlando
Florida
Not Yet Recruiting
NuLine Clinical Trial Center
Pompano Beach
Florida
Not Yet Recruiting
University of South Florida
Tampa
Florida
Recruiting
MJ Research
Tampa
Florida
Not Yet Recruiting
Treasure Valley Medical Research
Boise
Idaho
Recruiting
Entopy Research LLC
Chicago
Illinois
Recruiting
Chicago ENT
Chicago
Illinois
Recruiting
EMEDR
Overland Park
Kansas
Recruiting
South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS
Mandeville
Louisiana
Recruiting
Chesapeake Clinical Research, Inc.
White Marsh
Maryland
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Recruiting
University of Missouri
Columbia
Missouri
Recruiting
Washington University School of Medicine
St Louis
Missouri
Not Yet Recruiting
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton
New Jersey
Not Yet Recruiting
Madison ENT & Facial Plastic Surgery
New York
New York
Recruiting
New York Allergy and Sinus Center
New York
New York
Recruiting
Equity Medical
The Bronx
New York
Recruiting
UCMC
Cincinnati
Ohio
Not Yet Recruiting
Optimed Research, LTD
Columbus
Ohio
Recruiting
Charleston ENT
Charleston
South Carolina
Not Yet Recruiting
Medical University of South Carolina- Department of Otolaryngology and Head and Neck Surgery
Charleston
South Carolina
Not Yet Recruiting
Alina Clinical Trials
Dallas
Texas
Recruiting
UT Southwestern Medical Center
Dallas
Texas
Not Yet Recruiting
University of Texas Physicians Department of Otorhinolaryngology Clinc
Houston
Texas
Recruiting
Ear Nose and Throat Associates of Texas PA
McKinney
Texas
Recruiting
Alamo ENT Associates
San Antonio
Texas
Recruiting
Eastern Virginia Medical School
Norfolk
Virginia
Recruiting
Richmond Ear Nose and Throat
Richmond
Virginia
Not Yet Recruiting
+ 162 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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