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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05248997
Recruitment Status : Recruiting
First Posted : February 21, 2022
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps Drug: rimegepant 75 mg ODT Drug: Matching placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 17, 2022
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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


Secondary Outcome Measures :
  1. To evaluate rimegepant compared to placebo on change from baseline of Total Nasal Symptom Score (TNSS) [ Time Frame: 2 hours post-dose ]
    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. To evaluate rimegepant compared to placebo on change from baseline in nasal obstruction (congestion) [ Time Frame: 2 hours post-dose ]
    Nasal obstruction (congestion) will be assessed using the number of evaluable subjects that report nasal obstruction (congestion) score on NRS (0-10)

  3. To evaluate rimegepant compared to placebo on change from baseline in nasal discharge [ Time Frame: 2 hours post-dose ]
    Nasal discharge will be assessed using the number of evaluable subjects that report nasal discharge score on NRS (0-10)

  4. To evaluate rimegepant compared to placebo on headache pain relief [ Time Frame: 2 hours post-dose ]
    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

  5. To evaluate rimegepant compared to placebo on the probability of requiring rescue medication [ Time Frame: Within 24 hours of initial treatment ]
    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)


Eligibility Criteria
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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:

  • 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.
Contacts and Locations
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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): NCT05248997


Contacts
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Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05248997    
Other Study ID Numbers: BHV3000-316
C4951015 ( Other Identifier: Alias Study Number )
First Posted: February 21, 2022    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Chronic Rhinosinusitis (CRS)
Chronic Rhinosinusitis (CRS) with Nasal Polyps
Chronic Rhinosinusitis (CRS) without Nasal Polyps
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Respiratory Tract Infections
 Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases