LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)

Lyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Treatments: Drug: Bilateral sham procedure control (Part 2); Drug: LYR-220 Design 2 (Part 1 and Part 2); Drug: LYR-220 Design 1 (Part 1 only)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05035654

LYR-220-2021-001

Details and patient eligibility

About

This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.

Full description

This is a Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220. The study will consist of two parts: Part 1 will enroll up to 10 patients and is open label. Part 2 is randomized, sham controlled and will enroll approximately 40 patients. The study follow-up duration is 28 weeks.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic rhinosinusitis.
• Has had a prior bilateral total ethmoidectomy.
• Has computed tomography (CT) ethmoid cavity opacification.
• Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit.
• Minimum cardinal symptom score.
• Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law.
• Agrees to comply with all study requirements.

Exclusion criteria

• Pregnant or breast feeding.
• Known history of hypersensitivity or intolerance to corticosteroids.
• History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
• Known history of hypothalamic pituitary adrenal axial dysfunction.
• Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
• Past or present functional vision in only one eye.
• Past, present, or planned organ transplant or chemotherapy with immunosuppression.
• With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.
• Ethmoidectomy that was unilateral or partial.
• Currently participating in an investigational drug or device study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Part 1: Treatment Arm LYR-220 Design 1

Experimental group

Description:

Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1

Treatment:

Drug: LYR-220 Design 1 (Part 1 only)

Part 1 and Part 2: Treatment Arm LYR-220 Design 2

Experimental group

Description:

Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2

Treatment:

Drug: LYR-220 Design 2 (Part 1 and Part 2)

Part 2: Treatment Arm Bilateral sham procedure control

Sham Comparator group

Description:

Bilateral sham procedure control

Treatment:

Drug: Bilateral sham procedure control (Part 2)