Trial Outcomes & Findings for LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) (NCT NCT04041609)

Last Updated: 2023-07-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Week 4

Results posted on

2023-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	LYR-210 (Low Dose) In-office bilateral placement of the LYR-210 drug depot (mometasone furoate 2500 µg) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) In-office bilateral placement of the LYR-210 drug depot (mometasone furoate 7500 µg) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure In-office bilateral sham procedure Sham comparator: Sham comparator
Overall Study STARTED	24	23	24
Overall Study COMPLETED	17	15	17
Overall Study NOT COMPLETED	7	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 4

Population: ITT analysis set: all randomized subjects who receive the study treatment or have a treatment attempt on Day 1 and have post-Day 1 assessments available

Outcome measures

Outcome measures
Measure	LYR-210 (Low Dose) n=23 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=21 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure n=23 Participants In-office bilateral sham procedure Sham comparator: Sham comparator
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4	-2.24 score on a scale Standard Error 0.637	-2.65 score on a scale Standard Error 0.651	-2.28 score on a scale Standard Error 0.611

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LYR-210 (Low Dose) n=23 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=21 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure n=23 Participants In-office bilateral sham procedure Sham comparator: Sham comparator
Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24	-30.0 score on a scale Standard Error 5.32	-40.7 score on a scale Standard Error 5.76	-21.7 score on a scale Standard Error 5.10

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	LYR-210 (Low Dose) n=23 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=21 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure n=23 Participants In-office bilateral sham procedure Sham comparator: Sham comparator
CFBL in Chronic Sinusitis Symptom Scores at Week 24	-3.36 score on a scale Standard Error 0.668	-4.32 score on a scale Standard Error 0.682	-2.68 score on a scale Standard Error 0.640

SECONDARY outcome

Timeframe: Week 24

Population: The outcome measure is based on the Intent-to-treat (ITT) set which includes all randomized subjects who received the study treatment and had a post-Day 1 imaging assessment which could be analyzed by the imaging core lab.

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.

Outcome measures

Outcome measures
Measure	LYR-210 (Low Dose) n=19 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=19 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure n=18 Participants In-office bilateral sham procedure Sham comparator: Sham comparator
Participants With Improved Bilateral Zinreich Score at Week 24	13 Participants	14 Participants	10 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.

To evaluate the safety and tolerability of LYR-210

Outcome measures

Outcome measures
Measure	LYR-210 (Low Dose) n=24 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=23 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure n=23 Participants In-office bilateral sham procedure Sham comparator: Sham comparator
The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks	11 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 Weeks

Population: Participants who had evaluable plasma concentration at week 4.

To evaluate the pharmacokinetics of LYR-210

Outcome measures

Outcome measures
Measure	LYR-210 (Low Dose) n=20 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=16 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure In-office bilateral sham procedure Sham comparator: Sham comparator
Plasma Drug Concentrations of MF at Week 4	13.6110 pg/mL Standard Deviation 5.21710	45.3500 pg/mL Standard Deviation 11.40783	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Participants who had evaluable plasma concentration at week 12.

To evaluate the pharmacokinetics of LYR-210

Outcome measures

Outcome measures
Measure	LYR-210 (Low Dose) n=16 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=14 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure In-office bilateral sham procedure Sham comparator: Sham comparator
Plasma Drug Concentrations of MF at Week 12	21.6500 pg/mL Standard Deviation 7.77869	30.9143 pg/mL Standard Deviation 12.04657	—

Adverse Events

LYR-210 (Low Dose)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

LYR-210 (High Dose)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Sham Procedure

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LYR-210 (Low Dose) n=24 participants at risk In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=23 participants at risk In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure n=23 participants at risk In-office bilateral sham procedure Sham comparator: Sham comparator
Infections and infestations Acarodermatitis	4.2% 1/24 • Number of events 1 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Infections and infestations Chronic Sinusitis	0.00% 0/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	4.3% 1/23 • Number of events 1 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.

Other adverse events

Other adverse events
Measure	LYR-210 (Low Dose) n=24 participants at risk In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=23 participants at risk In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure n=23 participants at risk In-office bilateral sham procedure Sham comparator: Sham comparator
General disorders Facial Pain	4.2% 1/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	8.7% 2/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Infections and infestations Chronic Sinusitis	16.7% 4/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	17.4% 4/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	30.4% 7/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Infections and infestations Rhinitis	4.2% 1/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	17.4% 4/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Infections and infestations Upper respiratory tract infection	8.3% 2/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	4.3% 1/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	4.3% 1/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	8.7% 2/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Nervous system disorders Dizziness	8.3% 2/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Nervous system disorders Headache	8.3% 2/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	4.3% 1/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	13.0% 3/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 4/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	13.0% 3/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	4.3% 1/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 2/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	0.00% 0/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	4.3% 1/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	8.7% 2/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 4/24 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	8.7% 2/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.	4.3% 1/23 • 1 year AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.

Additional Information

Lyra Clinical

Lyra Therapeutics

Phone: 617-393-4600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	LYR-210 (Low Dose) n=23 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	LYR-210 (High Dose) n=21 Participants In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot	Sham Procedure n=23 Participants In-office bilateral sham procedure Sham comparator: Sham comparator	Total n=67 Participants Total of all reporting groups
Age, Continuous	42.3 Years STANDARD_DEVIATION 12.72 • n=5 Participants	46.9 Years STANDARD_DEVIATION 12.72 • n=7 Participants	41.3 Years STANDARD_DEVIATION 14.68 • n=5 Participants	43.4 Years STANDARD_DEVIATION 13.44 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	67 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	65 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment New Zealand	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Australia	4 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment Europe	18 participants n=5 Participants	18 participants n=7 Participants	20 participants n=5 Participants	56 participants n=4 Participants