Recruiting NCT06338995

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

Phase III Interventional Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: LY3650150, Placebo, Standard therapy for INCS.
Who it may be relevant to: Registry conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Belgium, Bulgaria, Canada +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

Interventions

Drug LY3650150
Administered SC.
Drug Placebo
Administered SC.
Drug Standard therapy for INCS
Administered as intranasal spray.

Primary outcome measures

Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity [Time frame: Baseline, Week 24]
Mean CFBL in Endoscopic Nasal Polyp Score (NPS) [Time frame: Baseline, Week 24]

Secondary outcome measures (6)

Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) [Time frame: Baseline, Week 24]
Mean change in Forced Expiratory Volume in 1 Second (FEV1) [Time frame: Baseline, Week 24]
Mean CFBL in Severity of Loss of Smell [Time frame: Baseline, Week 24]
Mean CFBL in Postnasal Drip [Time frame: Baseline, Week 24]
Mean Change from Baseline by Visit for the 22-item Sino-nasal Outcome Test (SNOT-22) [Time frame: Baseline, Week 24]
Mean Change from Baseline by Visit for the Nasal Peak Inspiratory Flow (NPIF) [Time frame: Baseline, Week 24]

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:

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment