A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Condition(s) studied
Investigational drug(s) / intervention(s)
LY3650150: Administered SC.
Placebo: Administered SC.
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
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 | 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 | Recruiting |
| Ark Clinical Research | Long Beach | California | 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.
More Eli Lilly and Company trials in Italy
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.
View NCT06338995 on ClinicalTrials.gov ↗ ← All trials in Italy