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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
• Intervention / Treatment: Drug: rimegepant 75 mg ODT; Drug: Matching placebo

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • La Mesa, California, United States, 91942
      • San Diego Clinical Research Center
    • La Mesa, California, United States, 91942
      • Velocity Clinical San Diego
    • Panorama City, California, United States, 91402
      • National Research Institute
    • Roseville, California, United States, 95628
      • Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
    • San Diego, California, United States, 92123
      • Sharp & Children's MRI Center, LLC (CT scan)
    • Torrance, California, United States, 90503
      • Breathe Clear Institute
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Colorado ENT & Allergy
  • Florida
    • Edgewater, Florida, United States, 32132
      • Velocity Clinical Research, New Smyrna Beach
    • Hollywood, Florida, United States, 33021
      • The Medici Medical Research, LLC
    • Miami, Florida, United States, 33155
      • Avantis Clinical Research
    • Pompano Beach, Florida, United States, 33064
      • Clinovation Research
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60657
      • ChicagoENT
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Kentuckiana Ear, Nose & Throat
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • George Stanley Walker, MD
    • New Orleans, Louisiana, United States, 70115
      • Best Clinical Trials, LLC (Administrative Only)
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Healthcare - Investigational Pharmacy
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital (Radiology)
    • Springfield, Missouri, United States, 65810
      • Clinvest Research, LLC
    • Weldon Spring, Missouri, United States, 63304
      • St Charles Clinical Research
  • New York
    • New Hyde Park, New York, United States, 11042
      • Northwell Health Department of Otolaryngology
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Tekton Research, Inc.
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma & Clinical Research Center
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • Velocity Clinical Research, Grants Pass
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Velocity Clinical Research, Anderson
    • Orangeburg, South Carolina, United States, 29118
      • Carolina ENT Clinic/CENTRI Inc.
  • Washington
    • Spokane, Washington, United States, 99204
      • Principle Research Solutions
    • Spokane, Washington, United States, 99201
      • Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
    • Spokane, Washington, United States, 99216
      • Spokane Ear, Nose & Throat / Columbia Surgical Specialists
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Allergy, Asthma & Sinus Center, S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rimegepant 75 mg ODT; One dose of rimegepant 75 mg ODT	Drug: rimegepant 75 mg ODT; One dose of rimegepant 75 mg ODT
Active Comparator: Matching Placebo; One dose of matching placebo	Drug: Matching placebo; One dose of matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose	Facial pain/pressure/fullness was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no facial pain/pressure/fullness" and 10 being "worst imaginable facial pain/pressure/fullness." Higher scores signified worse condition.	Baseline, 2 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose	TNSS was calculated as the sum of 3 symptom scores: facial pain/pressure/fullness, score ranged from 0 (no facial pain/pressure/fullness) to 10 (worst imaginable facial pain/pressure/fullness); nasal obstruction (congestion), score ranged from 0 (no nasal obstruction (congestion) to 10 (worst imaginable nasal obstruction (congestion); and nasal discharge, score ranged from 0 (no nasal discharge) to 10 (worst nasal discharge). TNSS overall score ranged from 0 (no nasal symptom) to 30 (worst nasal symptom); higher scores signified worse condition.	Baseline, 2 hours post-dose
Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose	Nasal obstruction (congestion) severity was assessed using a NRS ranging in integers from 0 (no nasal obstruction [congestion]) to 10 (worst imaginable nasal obstruction [congestion]). Higher scores signified worse condition.	Baseline, 2 hours post-dose
Change From Baseline in Nasal Discharge at 2 Hours Post-Dose	Nasal discharge severity was assessed using a NRS ranging in integers from 0 (no nasal discharge) to 10 (worst imaginable nasal discharge). Higher scores signified worse condition.	Baseline, 2 hours post-dose
Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose	Headache pain relief was defined as a headache pain level of none or mild at 2 hours post-dose on a 4-point Likert scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe).	2 hours post-dose
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose	Post 2 hours after dosing with study medication and after the 2-hour assessments were completed on the e-diary, participants were permitted to use the following rescue medications (non-study medications) such as: acetaminophen or aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug [NSAID]), oral antihistamines (non- sedating), oral decongestants, topical nasal decongestants, topical nasal anticholinergics.	Through 24 hours post-dose

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Biohaven Pharmaceutical Holding Company Ltd.
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): March 11, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Rhinosinusitis (CRS); Chronic Rhinosinusitis (CRS) with Nasal Polyps; Chronic Rhinosinusitis (CRS) without Nasal Polyps
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Paranasal Sinus Diseases; Rhinosinusitis; Polyps; Nasal Polyps; Sinusitis
• Other Study ID Numbers: BHV3000-316; C4951015 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No