Withdrawal of Dupilumab in Severe Asthma

Sponsor
University Hospital, Toulouse
Study ID
NCT06818019
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Stopping dupilumab — DRUG
    Stopping dupilumab with no dose-reducing or interval of time-increasing strategy

Study Details

Asthma management has been revolutionised by the development of biological therapies. Dupilumab is an anti-interleukin4 receptor marketed in 2020 for severe asthmatic patients with 2 exacerbations or more within the last 12 months. Although data showed that safety and efficacy of dupilumab are sustained when treatment is extended up to 3 years, no study has emerged regarding dupilumab discontinuation. This study aims to demonstrate the non-inferiority regarding strategy failure at 24 months of stopping dupilumab (intervention group) compared with its continuation (control group) in controlled asthma patients receiving this drug for at least 3 years.

Key Dates

Start date
Apr 2, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
205 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stopping dupilumab
    The experimental strategy comprises stopping dupilumab with no dose-reducing or interval of time-increasing strategy from the day of inclusion/randomisation
  • No Intervention: Dupilumab continuation
    Dupilumab continuation at the same dose and same interval as baseline

Primary Outcome Measure

Strategy failure [ Time Frame: 24 months ]

Central Contacts

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