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

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:
• 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.
• 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:
• 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.
• 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:
• 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). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.
• A nasal cavity tumor (malignant or benign).
• 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.