Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sanofi
Study ID
NCT02528214
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
    Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
  • Placebo — DRUG
    Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
  • Oral corticosteroid therapy (prednisone/prednisolone) — DRUG
    Oral administration.
  • Inhaled corticosteroid (ICS) therapy — DRUG
    Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).
  • Albuterol/Salbutamol — DRUG
    Oral inhalation as needed.
  • Levalbuterol/Levosalbutamol — DRUG
    Oral inhalation as needed.

Study Details

Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab in improving participants-reported outcomes. * To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.

Key Dates

Start date
Oct 15, 2015
Status verified
Nov 2017
Primary completion
Sep 20, 2017
Completion
Nov 13, 2017

Study Design

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

Arms

  • Placebo Comparator: Placebo q2w
    2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection every 2 weeks (q2w) for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable inhaled corticosteroid (ICS). OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
  • Experimental: Dupilumab 300 mg q2w
    2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

Primary Outcome Measure

Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control [ Time Frame: Baseline, Week 24 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840022Los AngelesCalifornia90048-
Investigational Site Number 840014Rolling Hills EstatesCalifornia90274-
Investigational Site Number 840002St LouisMissouri63110-
Investigational Site Number 840010PittsburghPennsylvania15213-
Investigational Site Number 840062AmarilloTexas79106-
Investigational Site Number 840070McKinneyTexas75069-
Investigational Site Number 840128McKinneyTexas75071-
Investigational Site Number 840118PlanoTexas75093-

Find similar trials in Los Angeles, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Investigational· Los Angeles, CAInvestigational· Rolling Hills Estates, CAInvestigational· St Louis, MOInvestigational· Pittsburgh, PAInvestigational· Amarillo, TXInvestigational· McKinney, TX

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