Phase 3 N=261 Randomized Quadruple-blind Treatment

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

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Bottom Line

View on ClinicalTrials.gov: NCT05248997 ↗

Enrolled (actual)

261

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose — -2.70; -2.61 Scores on a scale — p=0.7782

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: rimegepant 75 mg ODT (Drug); Matching placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose	-2.70; -2.61	0.7782
SECONDARY Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose	-7.04; -6.74	0.7079
SECONDARY Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose	-2.48; -2.25	0.4398
SECONDARY Change From Baseline in Nasal Discharge at 2 Hours Post-Dose	-1.81; -1.85	0.8890
SECONDARY Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose	59.4; 55.6	0.6412
SECONDARY Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose	7.3; 10.0	0.5001

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.

Eligibility 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 > 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05248997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.