Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  solution for injection subcutaneous
• Placebo — DRUG
  solution for injection subcutaneous

Study Details

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Key Dates

Start date

Dec 16, 2021

Status verified

Apr 2026

Primary completion

Mar 16, 2027

Completion

Jun 8, 2029

Study Design

Enrollment

1,339 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Dupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1
• Placebo Comparator: Placebo
  Matching placebo administered Q2W after an initial loading dose (2 injections) on Day 1

Primary Outcome Measure

Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population [ Time Frame: Week 8 to Week 52 ]

Locations (75)

Find similar trials in Cullman, AL

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