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L'essai clinique NCT06338995 pour Rhinusinusite chronique avec polypes nasaux (RSCpN) est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) Phase III 510
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
- 18790
- J2T-MC-KGBU (Autre Identifiant) (Eli Lilly and Company)
- 2023-508760-29-00 (Autre Identifiant) (EU CT Number)
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalLebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Note: Enrollment of adolescents will be open-label, with all adolescents assigned to the lebrikizumab Q2W/Q4W treatment arm. | LY3650150 Administered SC. Standard therapy for INCS Administered as intranasal spray. |
ExpérimentalLebrikizumab Q2W/every 8 weeks (Q8W) Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS. | LY3650150 Administered SC. Standard therapy for INCS Administered as intranasal spray. |
Comparateur placeboPlacebo Q2W/Q4W Placebo will be given as SC injection. Participants will receive background therapy with INCS. | PLACEBO Administered SC. Standard therapy for INCS Administered as intranasal spray. |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity | NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary. | Baseline, Week 24 |
Mean CFBL in Endoscopic Nasal Polyp Score (NPS) | The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps. | Baseline, Week 24 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) | Central read on sinus computed tomography (CT) scans for the Lund Mackay score (LMK) will be performed. Review of the CT scans of the right and left frontal sinuses will include the use of a scoring system. The LMK scoring system is a 3-point grading scale where 0 = normal, 1 = partial opacification, and 2 = total opacification. The total score is the sum of the scores from each side and ranges from 0 to 24, where 0 indicates no disease and 24 indicates the most severe disease. | Baseline, Week 24 |
Mean change in Forced Expiratory Volume in 1 Second (FEV1) | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. | Baseline, Week 24 |
Mean CFBL in Severity of Loss of Smell | Participants will be asked about the severity of loss of smell using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of loss of smell, for the previous 24 hours. This assessment will be collected in the participant eDiary. | Baseline, Week 24 |
Mean CFBL in Postnasal Drip | Postnasal drip is rated by study participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours. This assessment will be collected in the participant eDiary. | Baseline, Week 24 |
Mean Change from Baseline by Visit for the 22-item Sino-nasal Outcome Test (SNOT-22) | The 22-item Sino-nasal outcome test assessing sino-nasal and auricular function, psychological impact, productivity, and sleep quality. Participants will be asked to recall their experiences over the past 2 weeks and rate their symptoms on a scale ranging from 0, which corresponds to no problem, to 5, which corresponds to problem as bad as it can be. | Baseline, Week 24 |
Mean Change from Baseline by Visit for the Nasal Peak Inspiratory Flow (NPIF) | NPIF measures the maximum inspiratory flow rate through both nostrils during inspiration with results expressed in liters per min (L/min). Participants with NPIF results \>120 L/min represent no nasal obstruction. | Baseline, Week 24 |
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.
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.
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