A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- Interventions
- Registration Number
- NCT06338995
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 510
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Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).
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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.
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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.
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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.
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Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
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Have received a dose of lebrikizumab.
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Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period.
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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.
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Prior or current biologic treatment for CRSwNP and/or asthma including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab.
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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.
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Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening
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Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS
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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).
- A nasal cavity tumor (malignant or benign).
- Evidence of fungal rhinosinusitis.
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Have anosmia from COVID or any reason other than CRSwNP.
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Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.
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Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) LY3650150 Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) Standard therapy for INCS Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Lebrikizumab Q2W/every 8 weeks (Q8W) LY3650150 Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS. Lebrikizumab Q2W/every 8 weeks (Q8W) Standard therapy for INCS Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS. Placebo Q2W/Q4W Placebo Placebo will be given as SC injection. Participants will receive background therapy with INCS. Placebo Q2W/Q4W Standard therapy for INCS Placebo will be given as SC injection. Participants will receive background therapy with INCS.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) Baseline, Week 24 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.
Mean change in Forced Expiratory Volume in 1 Second (FEV1) Baseline, Week 24 FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Mean CFBL in Severity of Loss of Smell Baseline, Week 24 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.
Mean CFBL in Postnasal Drip Baseline, Week 24 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.
Trial Locations
- Locations (157)
AllerVie Clinical Research
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Keck Medicine of USC
🇺🇸Arcadia, California, United States
University of California, Irvine
🇺🇸Irvine, California, United States
DaVinci Research LLC
🇺🇸Roseville, California, United States
Breathe Clear Institute
🇺🇸Torrance, California, United States
Colorado ENT & Allergy
🇺🇸Colorado Springs, Colorado, United States
Orlando ENT & Allergy
🇺🇸Orlando, Florida, United States
NuLine Clinical Trial Center
🇺🇸Pompano Beach, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Scroll for more (147 remaining)AllerVie Clinical Research🇺🇸Birmingham, Alabama, United StatesWeily SoongPrincipal Investigator