Evaluation of Dupilumab in Children With Uncontrolled Asthma

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

6 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Pharmaceutical form: Solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form: Solution Route of administration: Subcutaneous
• Asthma Controller Therapies — DRUG
  Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhaled, oral
• Asthma Reliever Therapies — DRUG
  Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled

Study Details

Primary Objective: To evaluate the efficacy of dupilumab in children 6 to less than (\<) 12 years of age with uncontrolled persistent asthma. Secondary Objective: To evaluate in children 6 to \<12 years of age with uncontrolled persistent asthma: * The safety and tolerability of dupilumab. * The evaluate the effect of dupilumab in improving participant reported outcomes including health related quality of life. * The dupilumab systemic exposure and incidence of anti-drug antibodies. * The evaluate the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.

Key Dates

Start date

Apr 21, 2017

Status verified

Mar 2022

Primary completion

Aug 26, 2020

Completion

Aug 26, 2020

Study Design

Enrollment

408 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo (for Dupilumab), subcutaneous (SC) injection every 2 weeks (q2w) for 52 weeks in combination with stable-dose background therapy of medium-dose inhaled corticosteroids (ICS) with a second controller medication (i.e., long-acting β2 agonist \[LABA\], long acting muscarinic antagonist \[LAMA\], leukotriene receptor antagonist \[LTRA\] or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).
• Experimental: Dupilumab
  Dupilumab 200 milligrams (mg) (in 1.14 milliliters \[mL\] for \>30 kilograms \[kg\] bodyweight \[BW\]) or 100 mg (in 0.67 mL for less than or equal to (\<=) 30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA\] or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64).

Primary Outcome Measure

Annualized Rate of Severe Exacerbation Events During the 52-Week Treatment Period: Baseline Blood Eosinophils >=300 Cells Per Microliter Population [ Time Frame: Baseline to Week 52 ]

Locations (18)

Find similar trials in Birmingham, AL

Related Studies

• Personalized Environment and Genes Study
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Chapel Hill, North Carolina
• Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
  Recruiting · Gelb, Arthur F., M.D. · Lakewood, California
• Study of the Effect of Innate on the Inflammatory Response to Endotoxin
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Research Triangle Park, North Carolina
• Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
  PHASE4 · Recruiting · Gelb, Arthur F., M.D. · Lakewood, California