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

Launched by ELI LILLY AND COMPANY · Mar 25, 2024

Keywords

ClinConnect Summary

The CONTRAST-NP clinical trial is studying a medication called lebrikizumab to see how well it works and how safe it is for adults with chronic rhinosinusitis and nasal polyps. This condition can cause ongoing nasal congestion, loss of smell, and other uncomfortable symptoms. To join the study, participants need to have a doctor’s diagnosis of chronic rhinosinusitis with nasal polyps and have been experiencing symptoms for at least eight weeks. They should also have tried other treatments, such as systemic corticosteroids or nasal surgery, within the last two years.

Participants in the trial can expect to be involved for about 18 months, during which they will receive the study medication and attend regular check-ups to monitor their health and symptoms. This study is currently recruiting men and women aged 18 and older who meet the eligibility criteria. It's important for potential participants to know that there are certain conditions and previous treatments that may prevent them from joining, such as recent surgeries or specific medical conditions. Overall, this study aims to provide valuable information that could improve treatment options for those suffering from this condition.

Gender

ALL

Eligibility 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.
• 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) 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.