Evaluating lebrikizumab for chronic rhinosinusitis with nasal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Medovation Research
  Huntsville, Alabama, United States Recruiting
• Novak Clinical Research - Tucson - North La Cholla Boulevard
  Tucson, Arizona, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• Adcrc
  La Mesa, California, United States Recruiting
• Ark Clinical Research
  Long Beach, California, United States Recruiting

+152 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis with Nasal Polyps

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• Tezepelumab in real-world CRSwNP: a real-world look at patient outcomes

  This study tests tezepelumab in adults with chronic rhinosinusitis with nasal polyps to see how their symptoms and daily life change in routine care over about two years.

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• Lebrikizumab for adults with nummular eczema

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• BBT002 in healthy adults and in people with chronic rhinosinusitis with nasal polyps

  This study tests BBT002 versus placebo to see how it acts, how safe it is, and whether it helps people with chronic rhinosinusitis with nasal polyps, with or without asthma.

  Recruiting at 12 sites Phase 1/2 Bambusa Therapeutics · Beijing, Beijing Municipality and 11 other locations · NCT07436949

• Real-world use of tezepelumab for chronic rhinosinusitis with nasal polyps in Russia

  This study will see how tezepelumab works in adults in Russia who have chronic rhinosinusitis with nasal polyps, with or without asthma.

  Recruiting at 10 sites AstraZeneca · Kazan' and 9 other locations · NCT07399665

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.