A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

Eligibility 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.
• * 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.