Chronic Rhinosinusitis (CRS) With and Without Nasal PolypsPhase 3NCT05248997
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
A Phase 3 study testing rimegepant 75 mg ODT in people with Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, run by Pfizer at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
- What is being tested?
- rimegepant 75 mg ODT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 33 sitesUnited States
- Study dates
- 17 Feb 2022to 2 Apr 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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 locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Treasure Valley Medical Research
Boise, Idaho, 83706
ChicagoENT
Chicago, Illinois, 60657
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
University of Missouri Hospital & Clinics, ENT & Allergy Center of Missouri
Columbia, Missouri, 65201
University of Missouri Healthcare - Investigational Pharmacy
Columbia, Missouri, 65212
University of Missouri Hospital (Radiology)
Columbia, Missouri, 65212
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, 32132
Tekton Research, Inc.
Edmond, Oklahoma, 73013
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, 53228
The Medici Medical Research, LLC
Hollywood, Florida, 33021
San Diego Clinical Research Center
La Mesa, California, 91942
Velocity Clinical San Diego
La Mesa, California, 91942
Kentuckiana Ear, Nose & Throat
Louisville, Kentucky, 40205
Velocity Clinical Research, Medford
Medford, Oregon, 97504
Avantis Clinical Research
Miami, Florida, 33155
Northwell Health Department of Otolaryngology
New Hyde Park, New York, 11042
Best Clinical Trials, LLC (Administrative Only)
New Orleans, Louisiana, 70115
George Stanley Walker, MD
New Orleans, Louisiana, 70115
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Carolina ENT Clinic/CENTRI Inc.
Orangeburg, South Carolina, 29118
National Research Institute
Panorama City, California, 91402
Clinovation Research
Pompano Beach, Florida, 33064
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
Roseville, California, 95628
Sharp & Children's MRI Center, LLC (CT scan)
San Diego, California, 92123
Spokane Ear, Nose & Throat/ Columbia Surgical Specialists
Spokane, Washington, 99201
Principle Research Solutions
Spokane, Washington, 99204
Spokane Ear, Nose & Throat / Columbia Surgical Specialists
Spokane, Washington, 99216
Clinvest Research, LLC
Springfield, Missouri, 65810
Breathe Clear Institute
Torrance, California, 90503
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
St Charles Clinical Research
Weldon Spring, Missouri, 63304
About this study
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
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.
- Being tested
- rimegepant 75 mg ODT, Matching placebo
- Keywords
- Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) with Nasal Polyps, Chronic Rhinosinusitis (CRS) without Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rimegepant 75 mg ODTDrug
One dose of rimegepant 75 mg ODT
Matching placeboDrug
One dose of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| rimegepant 75 mg ODT | Active comparator | One dose of rimegepant 75 mg ODT Receives: Drug: rimegepant 75 mg ODT |
| Matching Placebo | Active comparator | One dose of matching placebo Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 hours post-dose
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Through 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start17 Feb 2022
- Primary completion11 Mar 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (CRS) With and Without Nasal PolypsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248997
- Sponsor's protocol ID
- BHV3000-316
- Other IDs
- C4951015
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Franjic D, Fountaine RJ, Nalpas C, Goswami B, Fullerton T. Efficacy and safety of rimegepant 75 mg orally disintegrating tablet for the acute treatment of chronic rhinosinusitis in adults: Results from a multicenter, randomized, placebo-controlled, phase 2/3 trial. PLoS One. 2026 Mar 4;21(3):e0342907. doi: 10.1371/journal.pone.0342907. eCollection 2026.
PubMed 41779821