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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06338995
Other study ID # 18790
Secondary ID J2T-MC-KGBU2023-
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 29, 2024
Est. completion date October 2026

Study information

Verified date May 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial 1-877-CTLILLY
Phone 1-317-615-4559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 510
Est. completion date October 2026
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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) or may require a dose change during study. - Prior or current biologic treatment for CRSwNP and/or asthma including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab. - 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). 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


Related Conditions & MeSH terms


Intervention

Drug:
LY3650150
Administered SC.
Placebo
Administered SC.
Standard therapy for INCS
Administered as intranasal spray.

Locations

Country Name City State
Belgium Pneumocare Erpent
Belgium UZ Gent Gent Oost-Vlaanderen
Belgium Cliniques Universitaires Saint-Luc Avenue Hippocrate 10 Sint-Lambrechts-Woluwe
Bulgaria Multiprofile Hospital For Active Treatment Dr Tota Venkova A Gabrovo
Bulgaria Medical Center Medconsult Pleven OOD Pleven
Bulgaria Diagnostic-Consultative Centre Ascendent EOOD Sofia
Bulgaria Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia, Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna Sofia
Bulgaria Multiprofile Hospital for Active treatment Trakia EOOD Zagora
Italy AOU Careggi- University of Florence Florence
Italy Ospedale San Raffaele Milano Lombardia
Italy AOU Federico II Via Pansini Napoli
Italy Fondazione Policlinico A. Gemelli IRCCS Rome
Italy ASST Brianza - Vimercate Hospital Vimercate
United States Treasure Valley Medical Research Boise Idaho
United States Colorado ENT & Allergy Colorado Springs Colorado
United States South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS Mandeville Louisiana
United States Ear Nose and Throat Associates of Texas PA McKinney Texas
United States Richmond Ear Nose and Throat Richmond Virginia
United States DaVinci Research LLC Roseville California
United States Alamo ENT Associates San Antonio Texas
United States Chesapeake Clinical Research, Inc. White Marsh Maryland

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity 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. Baseline, Week 24
Primary Mean CFBL in Endoscopic Nasal Polyp Score (NPS) 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. Baseline, Week 24
Secondary Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) Central read on sinus computed tomography (CT) scans for the Lund Mackay score (LMK) will be performed. Review of the CT scans of the right and left frontal sinuses will include the use of a scoring system. The LMK scoring system is a 3-point grading scale where 0 = normal, 1 = partial opacification, and 2 = total opacification. The total score is the sum of the scores from each side and ranges from 0 to 24, where 0 indicates no disease and 24 indicates the most severe disease. Baseline, Week 24
Secondary Mean change in Forced Expiratory Volume in 1 Second (FEV1) FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Baseline, Week 24
Secondary Mean CFBL in Severity of Loss of Smell Participants will be asked about the severity of loss of smell using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of loss of smell, for the previous 24 hours. This assessment will be collected in the participant eDiary. Baseline, Week 24
Secondary Mean CFBL in Postnasal Drip Postnasal drip is rated by study participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours. This assessment will be collected in the participant eDiary. Baseline, Week 24
See also
  Status Clinical Trial Phase
Completed NCT03956862 - GB001 in Adult Participants With Chronic Rhinosinusitis Phase 2
Not yet recruiting NCT06231004 - Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP