Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

Conditions

• Asthma

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.
• Inhaled corticosteroid (ICS) therapy — DRUG
  Oral inhalation, stable dose (medium or 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 (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. * To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

Key Dates

Start date

Apr 27, 2015

Status verified

Jun 2018

Primary completion

Jul 29, 2017

Completion

Nov 23, 2017

Study Design

Enrollment

1,902 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo (for Dupilumab 200 mg) q2w
  2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
• Experimental: Dupilumab 200 mg q2w
  2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
• Placebo Comparator: Placebo (for Dupilumab 300 mg) q2w
  2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. 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 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.

Primary Outcome Measure

Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population [ Time Frame: Baseline to Week 52 ]

Locations (116)

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