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Evaluating lebrikizumab for chronic rhinosinusitis with nasal polyps

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/LY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids

Phase 3 Interventional Eli Lilly and Company · NCT06338995

This study is testing a new drug called lebrikizumab to see if it can help adults with chronic rhinosinusitis and nasal polyps feel better while they are already using nasal sprays.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment510 (estimated)
Ages12 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionslebrikizumab, rituximab, immunotherapy
Locations194 sites (Birmingham, Alabama and 193 other locations)
Trial IDNCT06338995 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of lebrikizumab, an investigational drug, in adult patients suffering from chronic rhinosinusitis with nasal polyps who are currently treated with intranasal corticosteroids. Participants will be monitored over an 18-month period to determine how well the treatment alleviates symptoms compared to a placebo. The study will include individuals with a history of nasal polyps and ongoing symptoms, ensuring a targeted approach to treatment. The research will also evaluate the impact of lebrikizumab on patients with stable asthma.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with chronic rhinosinusitis and bilateral nasal polyps who have not responded adequately to intranasal corticosteroids.

Not a fit: Patients who have previously received lebrikizumab or those with uncontrolled asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic rhinosinusitis and nasal polyps.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for chronic rhinosinusitis, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
* 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:

  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). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.
  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.

Where this trial is running

Birmingham, Alabama and 193 other locations

+144 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Rhinosinusitis With Nasal Polyps
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.