Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Treatments: Drug: Matching placebo; Drug: rimegepant 75 mg ODT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05248997

BHV3000-316

C4951015 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps.

Enrollment: 261 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least two episodes of facial pain/pressure/fullness of moderate or severe intensity on a 4-point rating scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) in the past 30 days prior to the Screening Visit.
• Subject agrees to study-required medication restrictions and the restriction of not starting new medication to treat CRS symptoms during the course of the study.
• Subject agrees to study-required birth control methods during the course of the study, and female subjects must not be breastfeeding.
• No clinically significant abnormality identified on the medical or laboratory evaluation.

Exclusion criteria

• Subject has primary headache disorder.
• Subject has history of nasal or facial surgery within the 6 months prior to screening.
• Subject has ongoing rhinitis medicamentosa.
• Subject has diagnosed or suspected invasive fungal rhinosinusitis.
• Subject is currently receiving aspirin desensitization or maintenance therapy for Samter's Triad.
• Subject has a history of recurrent acute sinusitis (four or more episodes per year of acute bacterial rhinosinusitis (ABRS) without signs or symptoms of rhinosinusitis between episodes).
• Body Mass Index > 35.0kg/m2
• Subject history of exclusionary medical conditions such as HIV disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions.
• Subjects taking/using excluded therapies.
• Participation in clinical trial with non-biological investigational agents or investigational interventional treatments.
• Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepant study.
• Planned participation in any other investigational clinical trial while participating in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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261 participants in 2 patient groups

rimegepant 75 mg ODT

Active Comparator group

Description:

One dose of rimegepant 75 mg ODT

Treatment:

Drug: rimegepant 75 mg ODT

Matching Placebo

Active Comparator group

Description:

One dose of matching placebo

Treatment:

Drug: Matching placebo