NCT04987944

Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma

Terminated Phase 1 Results posted Last updated 19 July 2024

What this trial tests

Phase 1 trial testing Zavegepant in Asthma in 45 participants. Terminated before completion.

Timeline

18 October 2021

Primary endpoint
29 March 2023

4 April 2023

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	treatment
Enrollment	45
Start date	18 October 2021
Primary completion	29 March 2023
Estimated completion	4 April 2023
Sites	10 locations across Canada

Drugs / interventions tested

• Zavegepant (zavegepant) — full drug profile →
• Placebo

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Percentage Decrease From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Any Time Between 3 and 7 Hours Post-Allergen Challenge Primary · Baseline (pre-allergen challenge on Day 27) and anytime between 3 and 7 hours post-challenge on Day 27

Allergen inhalation challenge was performed on Day 27 and FEV1 was measured using spirometry prior to the challenge and between 3 to 7 hours post allergen challenge to assess late asthmatic response (LAR). FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. The maximum percentage decrease was the difference between the baseline (pre-allergen challenge) FEV1 on Day 27 and lowest FEV1 between hours 3 and 7 on Day 27 divided by the baseline value from Day 27. Analysis was performed using analysis of covariance (ANCOVA) model with trea

Group	Value	95% CI
Zavegepant	19.7	9.9 – 29.5
Placebo	29.5	18.8 – 40.1

Maximum Percentage Decrease From Baseline in FEV1 at Any Time Between 0 and 2 Hours Post-Allergen Challenge Secondary · Baseline (pre-allergen challenge on Day 27) and anytime between 0 and 2 hours post-challenge on Day 27

Allergen inhalation challenge was performed on Day 27 and FEV1 was measured using spirometry prior to the challenge and between 0 to 2 hours post allergen challenge to assess early asthmatic response (EAR). FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. The maximum percentage decrease was the difference between the baseline (pre-allergen challenge) FEV1 on Day 27 and lowest FEV1 between hours 0 and 2 on Day 27 divided by the baseline value from Day 27. Analysis was performed using ANCOVA model with treatment as main effect and

Group	Value	95% CI
Zavegepant	30.5	20.1 – 40.8
Placebo	34.4	23.2 – 45.5

Change in Methacholine PC20 From Pre-Allergen Challenge to Post-Allergen Challenge Secondary · From Day -15 to Day 28

Airway hyperresponsiveness was assessed using methacholine provocation concentration causing a 20% decline in FEV1 (PC20). Change in PC20 from pre-allergen to post-allergen = PC20 in post-allergen challenge minus PC20 in pre-allergen challenge. Shift in PC20 was calculated as post-allergen challenge minus pre-allergen challenge (Day 28 minus Day 26), and baseline shift in PC20 was calculated as post-allergen challenge minus pre-allergen challenge (Day -13 minus Day-15). Analysis was performed using ANCOVA model with treatment as main effect and baseline shift as covariate.

Group	Value	95% CI
Zavegepant	0.165	-0.192 – 0.521
Placebo	-0.259	-0.671 – 0.154

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Secondary · From start of treatment on Day 1 up to Day 41

An adverse event (AE) was any untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any adverse event that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect or other important medical events. TEAEs were events wi

TEAEs

Group	Value	95% CI
Zavegepant	3
Placebo	4

TESAEs

Group	Value	95% CI
Zavegepant	0
Placebo	0

Number of Participants With Clinically Significant Laboratory Test Abnormalities on Treatment Secondary · From start of treatment on Day 1 to Day 28

The following laboratory parameters were assessed: hematology (eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets), chemistry (Albumin, alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bicarbonate, bilirubin, calcium, cholesterol, creatine kinase, creatinine, glucose, low-density lipoproteins \[LDL\], lactate dehydrogenase, potassium, sodium, triglycerides) and urinalysis (urine glucose and urine protein). Clinically significant laboratory test abnormalities were Grade 3 (severe) to Grade 4 (potentially life-threatenin

Group	Value	95% CI
Zavegepant	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: On treatment: From start of study treatment on Day 1 up to Day 28 and Follow up: From Day 29 to Day 41. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Zavegepant (On Treatment)

Serious: 0/7 (0%)

Deaths: 0/7

Placebo (On Treatment)

Serious: 0/8 (0%)

Deaths: 0/8

Zavegepant (Follow-up)

Serious: 0/7 (0%)

Deaths: 0/7

Placebo (Follow-up)

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (13 terms — click to expand)

Reaction	System	Zavegepant (On Treatment)	Placebo (On Treatment)	Zavegepant (Follow-up)	Placebo (Follow-up)
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04987944 adverse events section.

Sponsor's own description

This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Gepants - a long way to cure: a narrative review.
   Altamura C, Brunelli N, Marcosano M, Fofi L, et al · · 2022 · cited 32× · PMID 35650458 · DOI 10.1007/s10072-022-06184-8