Phase 2
Completed N=296
Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
Source: ClinicalTrials.gov NCT03387852 ↗Enrolled (actual)
296
Serious AEs
3.7%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Participants With Loss of Asthma Control — 40.5; 21.9; 27.0; 18.9 percentage of participants — p==0.0214
Summary
Primary Objective:
To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events.
Secondary Objectives:
To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1).
To evaluate the effects of coadministration of SAR440340 and dupilumab, compared with SAR440340 and compared with dupilumab, on FEV1.
To assess safety and tolerability of SAR440340 alone and in coadministration with dupilumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Loss of Asthma Control |
40.5; 21.9; 27.0; 18.9 | =0.0214 sig |
| SECONDARY Change From Baseline at Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
0.06; 0.11; 0.06; 0.14 | — |
| SECONDARY Change From Baseline at Week 12 in Post-bronchodilator Forced Expiratory Volume in 1 Second |
-0.02; -0.00; 0.06; 0.09 | — |
Eligibility Criteria
Inclusion criteria
- Adult participants with a physician diagnosis of asthma for at least 12 months based on the Global Initiative for Asthma (GINA) 2017 Guidelines.
- Participants with existing treatment with medium to high dose ICS (greater than or equal to [>=] 250 microgram (mcg) of fluticasone propionate twice a day (BID) or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or clinically comparable) in combination with a LABA as second controller for at least 3 months with a stable dose >=1 month prior to Visit 1.
- Participants with pre-bronchodilator FEV1 greater than (>) 40 percent (%) of predicted normal at Visit 1/Screening. Pre-bronchodilator FEV1 >=50% but less than or equal to ( 70 years of age (i.e., have reached the age of 71 at the screening visit).
- Participants with body mass index (BMI) 3.0 at Visit 2/randomization. During the screening period, an ACQ-5 of up to 10 pack-years.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03387852). 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. Informational only — not medical advice.