LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)

Phase 2

Completed

• Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: LYR-210; Other: Sham comparator

• Registration Number: NCT04041609
• Lead Sponsor: Lyra Therapeutics

Brief Summary

This is 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.

Detailed Description

LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.

Study Timeline

• Study Start: 2019-05-09
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Primary Completion: 2020-03-25
• Study Completion: 2021-02-04
• Status Verified: 2023-05
• Results First Submitted: 2023-05-10
• Results First Submitted QC: 2023-05-10
• Results First Posted: 2023-06-06
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Diagnosis of CS.
• Two trials of medical treatments for CS in the past.
• Minimum CS symptom score.
• Ability to tolerate topical anesthesia.
• 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.
• Agrees to comply with all study requirements.

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Exclusion Criteria

• Have undergone previous sinus surgery.
• Pregnant or breast feeding.
• Known history of hypersensitivity or intolerance to corticosteroids.
• History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
• Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
• Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
• Past or present functional vision in only one eye.
• Has cataracts
• Past, present, or planned organ transplant or chemotherapy with immunosuppression.
• Currently participating in an investigational drug or device study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYR-210 (High Dose)	LYR-210	In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus
LYR-210 (Low Dose)	LYR-210	In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus
Sham Procedure	Sham comparator	In-office bilateral sham procedure

Primary Outcome Measures

Name	Time	Method
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4	Week 4	Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.

Secondary Outcome Measures

Name	Time	Method
Plasma Drug Concentrations of MF at Week 12	12 weeks	To evaluate the pharmacokinetics of LYR-210
Plasma Drug Concentrations of MF at Week 4	4 Weeks	To evaluate the pharmacokinetics of LYR-210
Participants With Improved Bilateral Zinreich Score at Week 24	Week 24	Each sinus is assigned a score based on the percentage of opacification as follows: 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, 4 = 76 % to 99%, 5 = 100% or completely occluded. Each sinus pair has a bilateral score in the range of 0 to 10. Higher scores indicate higher severity of sinus opacification. Responder is defined as a participant with at least a 1-point decrease in the imaging score at Week 24 compared with baseline.
CFBL in Chronic Sinusitis Symptom Scores at Week 24	Week 24	Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24	24 weeks	Participants score the severity of their symptoms and social/emotional consequences of CS on a 6-point scale: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be. The scores are summed in the range of 0-110; higher scores indicate higher severity of symptoms or social/emotional consequences of CS.
The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks	24 weeks	To evaluate the safety and tolerability of LYR-210

Trial Locations

Locations (22)

Provita Sp. z o.o. Centrum Medyczne Angelius Provita; 🇵🇱 Katowice, Poland

Centrum Medyczne PROMED; 🇵🇱 Kraków, Poland

Vistamed Sp. z o.o.; 🇵🇱 Wrocław, Poland

University Hospital for Otorhinolaryngology, Medical University of Graz; 🇦🇹 Wien, Austria

Centrum Medyczne Plejady; 🇵🇱 Kraków, Poland

Centrum Zdrowia MDM; 🇵🇱 Warszawa, Poland

Monash Health; 🇦🇺 Clayton, Australia

Westmead Hospital; 🇦🇺 Westmead, Australia

The ENT Centre; 🇦🇺 Hornsby, Australia

Royal Brisbane and Woman's Hospital; 🇦🇺 Brisbane, Australia

Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku; 🇨🇿 Hradec Králové, Prague, Czechia

St Anne's Faculty Hospital; 🇨🇿 Brno, Czechia

Fakultní nemocnice Plzeň; 🇨🇿 Plzen, Czech Republic, Czechia

Fakultni Nemocnice Brno OR; 🇨🇿 Brno, Czechia

Southern Clinical Trials Waitemata; 🇳🇿 Auckland, New Zealand

Clinical Trials New Zealand; 🇳🇿 Hamilton, New Zealand

Southern Clinical Trials Ltd; 🇳🇿 Christchurch, New Zealand

Middlemore Clinical Trials; 🇳🇿 Papatoetoe, New Zealand

P3 Research Tauranga; 🇳🇿 Tauranga, New Zealand

P3 Research Wellington; 🇳🇿 Wellington, New Zealand

Wellington Hospital; 🇳🇿 Wellington, New Zealand

Centrum Medyczne All-Med; 🇵🇱 Kraków, Poland