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LYR-210 for Chronic Sinusitis (ENLIGHTEN 1 Trial)
Phase 3
Waitlist Available
Research Sponsored by Lyra Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergone at least 2 trials of medical treatments in the past
Age ≥18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
ENLIGHTEN 1 Trial Summary
This trial is testing a new drug to see if it is better than the current standard of care. The trial is large, with patients at multiple centers, and is well-controlled with a safety extension phase.
Who is the study for?
Adults over 18 with chronic sinusitis, confirmed by CT scan, who've tried at least two medical treatments without success. They must understand the study and consent to participate. Excluded are those with previous nasal surgery, severe allergies well-controlled by steroids, current participation in other studies, pregnancy or breastfeeding women, and various conditions that could interfere with LYR-210 placement or affect survival.Check my eligibility
What is being tested?
The trial is testing LYR-210 against a sham procedure (placebo) for treating chronic sinusitis. Participants will also continue their usual sinus treatments. It's a large-scale phase III study where participants are randomly assigned to treatment groups and don't know which group they're in.See study design
What are the potential side effects?
Possible side effects of LYR-210 may include reactions related to corticosteroid sensitivity such as increased risk of infection, potential hormonal imbalances affecting the adrenal glands, glaucoma or ocular hypertension risks due to steroid exposure.
ENLIGHTEN 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least 2 different medical treatments before.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with CRS.
ENLIGHTEN 1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) in participants without nasal polyps.
Secondary outcome measures
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24
Tomography, Spiral Computed
Rhinorrhea
+3 moreSide effects data
From 2021 Phase 2 trial • 71 Patients • NCT0404160917%
Chronic Sinusitis
17%
Rhinitis
13%
Epistaxis
9%
Rhinorrhoea
9%
Facial Pain
4%
Oropharyngeal pain
4%
Upper respiratory tract infection
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
LYR-210 (High Dose)
LYR-210 (Low Dose)
Sham Procedure
ENLIGHTEN 1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LYR-210Experimental Treatment2 Interventions
Single administration of LYR-210 drug matrix (7500 μg)
Group II: Sham procedure controlPlacebo Group2 Interventions
Single mock administration procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LYR-210
2019
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Lyra TherapeuticsLead Sponsor
4 Previous Clinical Trials
321 Total Patients Enrolled
4 Trials studying Chronic Sinusitis
321 Patients Enrolled for Chronic Sinusitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor thinks I shouldn't join this study.I have had, am having, or will have an organ transplant or chemotherapy that weakens my immune system.I have nasal polyps that are moderate to severe.I have tried at least 2 different medical treatments before.I have been diagnosed with glaucoma or high eye pressure.I have had surgery on my nose before.I have not had dental work on my upper teeth in the last 4 weeks.You have confirmed disease in both sides of your ethmoid sinus, as shown on a CT scan.I have had surgery on my pituitary or adrenal gland.I can only see out of one eye.You have hay fever.My year-round nasal allergy symptoms are managed with daily nasal spray.I have or might have a serious fungal infection in my sinuses.I cannot tolerate skin numbing creams or internal camera examinations.I am 18 years old or older.You have a disease or condition that may make it hard for you to finish the study.I am not pregnant or breastfeeding, and if capable of becoming pregnant, I have tested negative for pregnancy.I have had brain or eye complications from a sinus condition.You have had bad reactions to corticosteroid medications in the past.You have a blockage that stops the LYR-210 from being put in the right place during an endoscopy.I have been diagnosed with CRS.Your body has a certain shape that could make it difficult for the doctor to put LYR-210 in the right place, as seen on a CT scan.I am willing to delay or cancel my planned sinonasal surgery for the study.I currently have COVID-19 or lingering symptoms from a past infection.I have severe asthma.I have a known issue with my adrenal gland function.My average symptom score is relevant.
Research Study Groups:
This trial has the following groups:- Group 1: LYR-210
- Group 2: Sham procedure control
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Sinusitis Patient Testimony for trial: Trial Name: NCT05219968 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many sites can patients participate in this clinical trial?
"There are 27 different clinical trial sites. Some examples of locations where these trials are being conducted include Charleston, Sacramento and Winston-Salem among other places. If you enroll in this study, it is advisable that you choose a location close to reduce travel burden."
Answered by AI
Has LYR-210 met the criteria for federal drug administration?
"LYR-210 has received a safety score of 3. This is due to the fact that there have been multiple Phase 3 trials conducted with this medication, signifying that not only is it efficacious, but also safe."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
What site did they apply to?
Lyra Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
my sinus is very bad. It causes me not to able to smell nor taste and can barely breath out of my nose.
PatientReceived 2+ prior treatments
I have a continuous sinus infection or rhinitis. My head hurts. I wake up with a runny nose. It is all day and all night the rhinitis.
PatientReceived no prior treatments
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