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

Sponsor

Biohaven Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05248997

Collaborator

Biohaven Pharmaceutical Holding Company Ltd. (Industry)

200

Enrollment

Locations

Arms

11.5

Anticipated Duration (Months)

7.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 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 With or Without Nasal Polyps

Actual Study Start Date :

Feb 17, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate rimegepant compared to placebo on change from baseline of Total Nasal Symptom Score (TNSS) [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
To evaluate rimegepant compared to placebo on change from baseline in nasal obstruction (congestion) [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)
To evaluate rimegepant compared to placebo on change from baseline in nasal discharge [2 hours post-dose]
Nasal discharge will be assessed using the number of evaluable subjects that report nasal discharge score on NRS (0-10)
To evaluate rimegepant compared to placebo on headache pain relief [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
To evaluate rimegepant compared to placebo on the probability of requiring rescue medication [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 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

Locations

	Site	City	State	Country	Postal Code
1	ENT Associates of San Diego	La Mesa	California	United States	91942
2	Velocity Clinical Research, San Diego	La Mesa	California	United States	91942
3	National Research Institute- Panorama City	Panorama City	California	United States	91402
4	Sacramento Ear Nose and Throat	Roseville	California	United States	95661
5	Colorado ENT & Allergy	Colorado Springs	Colorado	United States	80923
6	Tekton Research	Longmont	Colorado	United States	80501
7	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida	United States	32132
8	The Medici Medical Research	Hollywood	Florida	United States	33021
9	Treasure Valley Medical Research	Boise	Idaho	United States	83706
10	ChicagoENT	Chicago	Illinois	United States	60657
11	Kentuckiana Ear, Nose & Throat	Louisville	Kentucky	United States	40205
12	Best Clinical Trials	New Orleans	Louisiana	United States	70115
13	Clinical Research Institute	Minneapolis	Minnesota	United States	55402
14	University of Missouri	Columbia	Missouri	United States	65212
15	Clinvest Research	Springfield	Missouri	United States	65810
16	Northwell Health	New Hyde Park	New York	United States	11042
17	Tekton	Edmond	Oklahoma	United States	73013
18	Allergy, Asthma and Clinical Research Center	Oklahoma City	Oklahoma	United States	73120
19	Vpcri, P.C.	Tulsa	Oklahoma	United States	74136
20	Velocity Clinical Research, Grants Pass	Medford	Oregon	United States	97504
21	Velocity Clinical Research, Medford	Medford	Oregon	United States	97504
22	Velocity Clinical Research Anderson	Anderson	South Carolina	United States	29621
23	Medical University of South Carolina	Charleston	South Carolina	United States	29425
24	Carolina ENT Clinic/CENTRI Inc	Orangeburg	South Carolina	United States	29118
25	STAAMP Research, LLC	San Antonio	Texas	United States	78229
26	Spokane ENT	Spokane	Washington	United States	99201
27	WVU Medicine	Morgantown	West Virginia	United States	26506
28	Allergy, Asthma & Sinus Center, S.C.	Greenfield	Wisconsin	United States	53228