Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

Multicenter, phase III, randomized, blinded, controlled, parallel group.

Official Title

ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults

Details

This is a 24-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.

Keywords

Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis), Rhinosinusitis, Sinusitis, LYR-210, Background therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥18
  • Diagnosed as having CRS
  • Bilateral ethmoid disease confirmed on CT
  • Mean 3 cardinal symptom (3CS) score
  • Undergone at least 2 trials of medical treatments in the past
  • Has been informed of the nature of the study and provided written informed consent
  • Agrees to comply with all study requirements
  • If currently on a waiting list for sinonasal surgery, willing to be removed from the waiting list or have preplanned surgery date cancelled for the duration of the study. [Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study].

You CAN'T join if...

  • Inability to tolerate topical anesthesia
  • Previous nasal surgery
  • Presence of nasal polyp grade 2 or higher
  • Seasonal allergic rhinitis
  • Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
  • Severe asthma
  • History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
  • Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
  • Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
  • Known history of hypersensitivity or intolerance to corticosteroids
  • Known history of hypothalamic pituitary adrenal axial dysfunction
  • Previous pituitary or adrenal surgery
  • Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
  • Past or present acute or chronic intracranial or orbital complications of CRS
  • History or diagnosis (in either eye) of glaucoma or ocular hypertension
  • Past or present functional vision in only 1 eye
  • Past, present, or planned organ transplant or chemotherapy with immunosuppression
  • Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
  • Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
  • Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
  • Currently participating in an investigational drug or device study
  • Determined by the investigator as not suitable to be enrolled

Locations

  • University of California - Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Breathe Clear Institute accepting new patients
    Torrance California 90503 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lyra Therapeutics
ID
NCT05295459
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated