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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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).

Show all 12Show fewer

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.

City, postcode or hospital

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

Other trials in United States

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.

Conditions: 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 groups in NCT05248997
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.

17 Feb 20222 Apr 2024

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05248997
Acronym / sponsor ID: BHV3000-316
Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Keywords: Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) with Nasal Polyps, Chronic Rhinosinusitis (CRS) without Nasal Polyps
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 17 Feb 2022 (actual)
Primary completion: 11 Mar 2024 (actual)
Study completion: 2 Apr 2024 (actual)
First posted: 21 Feb 2022 (actual)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
rimegepant 75 mg ODT	Active comparator	Drug: rimegepant 75 mg ODTOne dose of rimegepant 75 mg ODT
Matching Placebo	Active comparator	Drug: Matching placeboOne dose of matching placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rimegepant 75 mg ODTOne dose of rimegepant 75 mg ODT	Drug	rimegepant 75 mg ODT
Matching placeboOne dose of matching placebo	Drug	Matching Placebo

Primary outcome

Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose
Time frame: Baseline, 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.

5 secondary outcomes

Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose
Time frame: Baseline, 2 hours post-dose
Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose
Time frame: Baseline, 2 hours post-dose
Change From Baseline in Nasal Discharge at 2 Hours Post-Dose
Time frame: Baseline, 2 hours post-dose
Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose
Time frame: Through 24 hours post-dose

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rimegepant 75 mg	131	98
Placebo	130	104

Primary outcome: Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose

Time frame: Baseline, 2 hours post-dose. Least squares mean (95% Confidence Interval). Unit: Scores on a scale

Measure	Rimegepant 75 mg n = 89	Placebo n = 92
Value	-2.70 (-3.16 to -2.25)	-2.61 (-3.06 to -2.17)

Rimegepant 75 mg vs Placebo: Difference in least square mean: -0.09 (95% CI -0.71 to 0.53), p = 0.7782, Linear model (LM)

Population analysed: Modified Intent to Treat (mITT) analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of \>= 6 on the NRS (0-10) prior to administration of treatment and provided at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rimegepant	0 of 99 (0%)	4 of 99 (4%)	0 of 99
Placebo	0 of 105 (0%)	5 of 105 (4.8%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41779821Franjic 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

33 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose (time frame: Baseline, 2 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05248997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.