Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 1)
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| ClinicalTrials.gov Identifier: NCT05219968 |
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Recruitment Status :
Recruiting
First Posted : February 2, 2022
Last Update Posted : February 21, 2023
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Sponsor:
Lyra Therapeutics
Information provided by (Responsible Party):
Lyra Therapeutics
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Brief Summary:
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Sinusitis Chronic Rhinosinusitis (Diagnosis) | Drug: LYR-210 Drug: Sham procedure control Other: Background Therapy | Phase 3 |
This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults |
| Actual Study Start Date : | January 27, 2022 |
| Estimated Primary Completion Date : | August 31, 2023 |
| Estimated Study Completion Date : | March 31, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: LYR-210
Single administration of LYR-210 drug matrix (7500 μg)
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Drug: LYR-210
LYR-210 drug matrix (mometasone furoate) Other: Background Therapy Daily Saline Irrigation |
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Sham Comparator: Sham procedure control
Single mock administration procedure
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Drug: Sham procedure control
Sham procedure control Other: Background Therapy Daily Saline Irrigation |
Primary Outcome Measures :
- Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) in participants without nasal polyps. [ Time Frame: 24 Weeks ]The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.
Secondary Outcome Measures :
- CFBL in the 7-day average CS score of nasal blockage/obstruction/congestion at Week 24 [ Time Frame: Week 24 ]Nasal blockage/obstruction/congestion is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms.
- CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24 [ Time Frame: Week 24 ]Anterior/posterior nasal discharge is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms.
- CFBL in the 7-day average CS score of facial pain/pressure at Week 24 [ Time Frame: Week 24 ]Facial pain/pressure is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms.
- CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24 [ Time Frame: Week 24 ]The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.
- CFBL in the 3-D volumetric CT score at Week 24 [ Time Frame: Week 24 ]
- Number and percent of participants requiring rescue treatment through Week 24 [ Time Frame: Week 24 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥18
- Diagnosed as having CRS
- Undergone at least 2 trials of medical treatments in the past
- Mean 3 cardinal symptom (3CS) score
- Bilateral ethmoid disease confirmed on CT
- Has been informed of the nature of the study and provided written informed consent
- Agrees to comply with all study requirements
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219968
Contacts
| Contact: Lyra Clinical | 617-393-4600 | lyraclinical@lyratx.com |
Locations
Show 56 study locations
Sponsors and Collaborators
Lyra Therapeutics
| Responsible Party: | Lyra Therapeutics |
| ClinicalTrials.gov Identifier: | NCT05219968 |
| Other Study ID Numbers: |
LYR-210-2021-004 |
| First Posted: | February 2, 2022 Key Record Dates |
| Last Update Posted: | February 21, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Sinusitis Respiratory Tract Infections Infections Paranasal Sinus Diseases |
Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases |