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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT03387852
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SAR440340 — DRUG
    Pharmaceutical form: Solution for Injection, Route of administration: SC
  • Dupilumab — DRUG
    Pharmaceutical form: Solution for Injection, Route of administration: SC
  • Fluticasone or Fluticasone/salmeterol combination — DRUG
    Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled
  • Placebo for SAR440340 — DRUG
    Pharmaceutical form: Solution for Injection, Route of administration: SC
  • Placebo for dupilumab — DRUG
    Pharmaceutical form: Solution for Injection, Route of administration: SC

Study Details

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.

Key Dates

Start date
Mar 12, 2018
Status verified
May 2022
Primary completion
Mar 21, 2019
Completion
Aug 7, 2019

Study Design

Enrollment
296 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAR440340
    Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, subcutaneous (SC) once every 2 weeks (Q2W) for 12 weeks.
  • Active Comparator: Dupilumab
    Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
  • Experimental: SAR440340 + Dupilumab
    Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.
  • Placebo Comparator: Placebo
    Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks.

Primary Outcome Measure

Percentage of Participants With Loss of Asthma Control [ Time Frame: From Baseline up to Week 12 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Investigational Site Number 8400026BirminghamAlabama35209-
Investigational Site Number 8400004Long BeachCalifornia90808-
Investigational Site Number 8400020Los AngelesCalifornia90025-
Investigational Site Number 8400001Rolling Hills EstatesCalifornia90274-
Investigational Site Number 8400013San JoseCalifornia95117-
Investigational Site Number 8400009StocktonCalifornia95207-
Investigational Site Number 8400016Colorado SpringsColorado80907-
Investigational Site Number 8400021Ann ArborMichigan48109-
Investigational Site Number 8400022MinneapolisMinnesota55402-
Investigational Site Number 8400007PapillionNebraska27103-
Investigational Site Number 8400025EdmondOklahoma73034-
Investigational Site Number 8400011MedfordOregon97504-
Investigational Site Number 8400024PortlandOregon97209-
Investigational Site Number 8400010DallasTexas75231-
Investigational Site Number 8400023DallasTexas75231-
Investigational Site Number 8400006PlanoTexas75093-
Investigational Site Number 8400008MurrayUtah84107-
Investigational Site Number 8400014MilwaukeeWisconsin53219-

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