A randomized Phase 2, double-blind, placebo-controlled, parallel-group, 2-arm study to assess the efficacy, safety, and tolerability of subcutaneous lunsekimig in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP)

Conditions

Respiratory tract diseases

Brief summary

Change in bilateral endoscopic nasal polyp score (NPS)

Detailed description

Change in patient-reported nasal congestion/obstruction score, Change in Lund-Mackay CT score, Change in the percent of maxillary sinus volume occupied by disease on CT scan, Change in SNOT-22 total score, Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell), Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score, Change in rhinosinusitis visual analog scale (VAS), Change in University of Pennsylvania Smell Identification Test (UPSIT) score, Change in patient-reported loss of smell score, Serum lunsekimig concentrations, Anti-drug antibodies (ADA) against lunsekimig, Incidence of participants with treatment-emergent adverse events (TEAEs), Incidence of participants with adverse events of special interest (AESI), Incidence of participants with serious adverse events (SAEs), Change in asthma control questionnaire (ACQ-5), Change in pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1), Change in pre-BD percent predicted FEV1

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in bilateral endoscopic nasal polyp score (NPS)	—

Secondary

Measure	Time frame
Change in patient-reported nasal congestion/obstruction score, Change in Lund-Mackay CT score, Change in the percent of maxillary sinus volume occupied by disease on CT scan, Change in SNOT-22 total score, Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell), Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score, Change in rhinosinusitis visual analog scale (VAS), Change in University of Pennsylvania Smell Identification Test (UPSIT) score, Change in patient-reported loss of smell score, Serum lunsekimig concentrations, Anti-drug antibodies (ADA) against lunsekimig, Incidence of participants with treatment-emergent adverse events (TEAEs), Incidence of participants with adverse events of special interest (AESI), Incidence of participants with serious adverse events (SAEs), Change in asthma control questionnaire (ACQ-5), Change in pre-bronchodilator forced expiratory volume in the first	—

Measure

Time frame

Change in patient-reported nasal congestion/obstruction score, Change in Lund-Mackay CT score, Change in the percent of maxillary sinus volume occupied by disease on CT scan, Change in SNOT-22 total score, Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell), Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score, Change in rhinosinusitis visual analog scale (VAS), Change in University of Pennsylvania Smell Identification Test (UPSIT) score, Change in patient-reported loss of smell score, Serum lunsekimig concentrations, Anti-drug antibodies (ADA) against lunsekimig, Incidence of participants with treatment-emergent adverse events (TEAEs), Incidence of participants with adverse events of special interest (AESI), Incidence of participants with serious adverse events (SAEs), Change in asthma control questionnaire (ACQ-5), Change in pre-bronchodilator forced expiratory volume in the first

—

Countries

Belgium, Bulgaria, Poland

Outcome results