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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Chronic Rhinosinusitis (CRS) With or Without Nasal Polyps

Conditions
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Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Intervention / Treatment
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* Drug: rimegepant 75 mg ODT
* Drug: Matching placebo


Participation Criteria
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Eligibility Criteria
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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 33kg/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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rimegepant 75 mg ODT<br>One dose of rimegepant 75 mg ODT | Drug: rimegepant 75 mg ODT<br>* One dose of rimegepant 75 mg ODT<br>|
| Active Comparator: Matching Placebo<br>One dose of matching placebo | Drug: Matching placebo<br>* One dose of matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of chronic rhinosinusitis with or without nasal polyps | Mean change from baseline of facial pain/pressure/fullness on Numeric Rating Score (NRS) (0-10) score | 2 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate rimegepant compared to placebo on change from baseline of Total Nasal Symptom Score (TNSS) | Total Nasal Symptom Score (TNSS) assessed using the number of evaluable subjects that report facial pain/pressure/fullness, nasal obstruction (congestion), and nasal discharge | 2 hours post-dose | 
| To evaluate rimegepant compared to placebo on change from baseline in nasal obstruction (congestion) | Nasal obstruction (congestion) will be assessed using the number of evaluable subjects that report nasal obstruction (congestion) score on NRS (0-10) | 2 hours post-dose | 
| To evaluate rimegepant compared to placebo on change from baseline in nasal discharge | Nasal discharge will be assessed using the number of evaluable subjects that report nasal discharge score on NRS (0-10) | 2 hours post-dose | 
| To evaluate rimegepant compared to placebo on headache pain relief | Headache pain relief will be assessed using the number of evaluable subjects that report a headache pain level of moderate or severe intensity at baseline and then report a pain level of none or mild at 2 hours post-dose using a 4-point Likert scale | 2 hours post-dose | 
| To evaluate rimegepant compared to placebo on the probability of requiring rescue medication | The probability of requiring rescue medication will be assessed using the number of subjects that take rescue medication within 24 hours after administration of study medication (rimegepant or placebo) | Within 24 hours of initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) with Nasal Polyps, Chronic Rhinosinusitis (CRS) without Nasal Polyps