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Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants

NCT03387852 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2022-06-14

Study results available
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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.

Conditions

Interventions

DRUG

SAR440340

Pharmaceutical form: Solution for Injection, Route of administration: SC

DRUG

Dupilumab

Pharmaceutical form: Solution for Injection, Route of administration: SC

DRUG

Fluticasone or Fluticasone/salmeterol combination

Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled

DRUG

Placebo for SAR440340

Pharmaceutical form: Solution for Injection, Route of administration: SC

DRUG

Placebo for dupilumab

Pharmaceutical form: Solution for Injection, Route of administration: SC

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2019-03-21
Completion
2019-08-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Chile
  • Mexico
  • Poland
  • Russia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387852 on ClinicalTrials.gov