Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

Sponsor
Sanofi
Study ID
NCT03782532
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab SAR231893 — DRUG
    Pharmaceutical form: Solution Route of administration: Subcutaneous
  • Placebo — DRUG
    Pharmaceutical form: Solution Route of administration: Subcutaneous
  • Asthma Controller Therapies (include prednisone/prednisolone) — DRUG
    Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhalation, oral
  • Asthma Reliever Therapies — DRUG
    Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled

Study Details

Primary Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma Secondary Objectives: * To evaluate the safety and tolerability of dupilumab * To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life * To evaluate dupilumab systemic exposure and immunogenicity

Key Dates

Start date
Jan 25, 2019
Status verified
Dec 2022
Primary completion
May 21, 2022
Completion
May 21, 2022

Study Design

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

Arms

  • Experimental: Dupilumab
    For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2
  • Placebo Comparator: Placebo for dupilumab
    For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose

Primary Outcome Measure

Change in pre-bronchodilator forced expiratory volume (FEV1) [ Time Frame: Baseline to Week 12 ]

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