A Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis (LANTERN Study)

INTERVENTION: Product Name: LYR‐210 Pharmaceutical Form: Implant INN or Proposed INN: Mometasone furoate CAS Number: 83919‐23‐7 Other descriptive name: MOMETASONE FUROATE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2500‐ Product Name: LYR‐210 Pharmaceutical Form: Implant INN or Proposed INN: Mometasone furoate CAS Number: 83919‐23‐7 Other descriptive name: MOMETASONE FUROATE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 7500‐ CONDITION: Chronic sinusitis ; MedDRA version: 20.1 Level: PT Classification code 10009137 Term: Chronic sinusitis System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: ; Secondary Objective: ‐ To evaluate the efficacy of LYR‐210 in improving CS7DA4S score at end of treatment; ‐ To evaluate the effect of LYR‐210 in reducing need for use of oral corticosteroid for CS; ‐ To evaluate the time to treatment failure; ‐ To evaluate the effect of LYR‐210 in reducing sinus inflammation as per magnetic resonance imaging (MRI); Main Objective: To evaluate the efficacy of LYR‐210 in improving the composite score of 7‐day average scores of 4 CS cardinal symptoms (CS7DA4S) at Week 4 Primary end point(s): Change from baseline (CFBL) in average daily nasal blockage/obstruction/congestion (CS7DA4S) score at Week 4 Timepoint(s) of evaluation of this end point: Week 4 SECONDARY OUTCOME: ; Secondary end point(s): ‐ CFBL in CS7DA4S score at Week 24 ; ‐ Percentage of subjects with use of oral corticosteroid for CS through Week 24 ; ‐ Time to treatment failure ; ‐ Percentage of subjects with at least 1 point of decrease in the bilateral Zinreich score in at least 1 pair of the posterior ethmoid, frontal, or sphenoid sinuses at Week 24; Timepoint(s) of evaluation of this end point: Various timepoints as indicated in the secondary endpoints INCLUSION CRITERIA: 1. Age =18. 2. A CS subject who a. fulfilled the diagnostic criteria for CS as per the European Position Paper on Rhinosinusitis and Nasal Polyps 2012 [2] or the International Consensus Statement on Allergy and Rhinology: Rhinosinusitis 2016 guidelines [3], and b. has a composite score of 7‐day average scores of 4 CS cardinal symptoms [2, 3] (CS7DA4S) = 7 (0‐3 scale for each of the symptoms) at Day 1 visit, and c. has had at least two trials of medical treatments in the past, one of which must include intranasal corticosteroid sprays (INCS) for a minimum of 4 weeks. 3. Ability to tolerate topical anesthesia. 4. Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site. 5. Agre