LYR-210 for Chronic Sinusitis

(ENLIGHTEN 1 Trial)

Recruiting at 52 trial locations

Overseen By Lyra Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Lyra Therapeutics

Must not be taking: Intranasal corticosteroids

Disqualifiers: Severe asthma, Nasal polyps, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

196 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing LYR-210 to see if it helps adults with chronic sinus problems by reducing swelling and opening nasal passages. LYR-210 is a new method designed to provide continuous treatment for patients with long-term sinus issues who have not improved with other treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have perennial rhinitis controlled by intranasal corticosteroids, you might not be eligible to participate.

What data supports the effectiveness of the treatment LYR-210 for chronic sinusitis?

Research shows that LYR-210, an implantable device that releases a steroid called mometasone furoate, improved symptoms in patients with chronic sinusitis over 24 weeks. It helped reduce symptoms like nasal congestion and improved quality of life scores in clinical studies. ^{1 2 3 4 5}

Is LYR-210 safe for humans?

LYR-210, a treatment for chronic rhinosinusitis, has been tested in clinical studies and shown to be safe for use in humans. It is designed to deliver a steroid directly to the sinus area over 24 weeks, and no significant safety concerns were reported in the studies. ^{1 3 4 6 7}

How is LYR-210 different from other treatments for chronic sinusitis?

LYR-210 is unique because it is an implantable device that delivers a corticosteroid called mometasone furoate directly to the inflamed sinus tissues for up to 24 weeks, providing long-term relief without the need for daily medication. This is different from typical treatments that require frequent dosing and may not reach the affected areas effectively. ^{1 3 4 8 9}

Eligibility Criteria

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.

Inclusion Criteria

Agrees to comply with all study requirements

I have tried at least 2 different medical treatments before.

Has been informed of the nature of the study and provided written informed consent

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LYR-210 or sham control for 24 weeks

24 weeks

Regular visits for monitoring and assessments

Safety Extension

Participants may continue treatment or crossover to LYR-210 for additional safety monitoring

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Background Therapy
• LYR-210
• Sham procedure control

Trial Overview 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.

Participant Groups

Group I: LYR-210 Experimental Treatment 2 Interventions

Single administration of LYR-210 drug matrix (7500 μg)

Group II: Sham procedure control Placebo Group 2 Interventions

Single mock administration procedure

Background Therapy is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Ultomiris for:

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic uremic syndrome (aHUS)

Approved in United States as Ultomiris for:

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic uremic syndrome (aHUS)

Approved in Japan as Ultomiris for:

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic uremic syndrome (aHUS)

Who Is Running the Clinical Trial?

Lyra Therapeutics

Lead Sponsor

Trials

5

Recruited

520+

Findings from Research

In a study of 66 patients with chronic rhinosinusitis with nasal polyps (CRSwNP), dupilumab significantly reduced symptoms and nasal polyp scores after 6 and 12 months, indicating its effectiveness as a treatment.

The safety profile of dupilumab was favorable, with only 12.7% of patients experiencing injection site reactions and 11.1% having transient hypereosinophilia, suggesting it is a safe option for managing CRSwNP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care. Galletti, C., Barbieri, MA., Ciodaro, F., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Validity of a new health-related quality of life instrument for patients with chronic sinusitis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Evidence of Steady and Sustained Drug Release from Long-Acting Implantable Corticosteroid Matrices for Chronic Rhinosinusitis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Phase 1 clinical study to assess the safety of a novel drug delivery system providing long-term topical steroid therapy for chronic rhinosinusitis. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of the Sinonasal Outcome Test-16 and activity impairment assessment in acute bacterial sinusitis. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

The Value of Multiple Medication Trials Prior to Balloon Sinuplasty in the Management of Chronic Sinonasal Disease. [2023]

8. England pubmed.ncbi.nlm.nih.gov

One-year low-dose erythromycin treatment of persistent chronic sinusitis after sinus surgery: clinical outcome and effects on mucociliary parameters and nasal nitric oxide. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Azithromycin and ciprofloxacin inhibit interleukin-8 secretion without disrupting human sinonasal epithelial integrity in vitro. [2022]