WIthdrawal of DUpilumab in Severe Asthma : a randomised non-inferiority-controlled trial

Conditions

Severe asthma

Brief summary

The proportion of patients with strategy failure defined as patients with an annualised number of asthma exacerbations ≥ 2 and/or resumption of dupilumab or switch to another biologic within 24 months following randomisation

Detailed description

To compare stopping dupilumab with its continuation regarding: a) the change in the asthma control test (ACT) score at 6, 12 and 24 months compared to baseline b) the time between baseline to loss of control defined with a reduction of 5 points or more on ACT score (compared to baseline) c) the time between baseline to the first exacerbation d) the number of exacerbations within 24 months e) the proportion of patients with ≥ 1 exacerbation and ≥ 1 severe exacerbation at 6, 12 and 24 months, The proportion of patients with resumption of dupilumab in the interventional group (stopping dupilumab) at 6, 12 and 24 months, The proportion of patients with AE or SAE in both groups

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Interventions

DRUGDupixent 300 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of patients with strategy failure defined as patients with an annualised number of asthma exacerbations ≥ 2 and/or resumption of dupilumab or switch to another biologic within 24 months following randomisation	—

Secondary

Measure	Time frame
To compare stopping dupilumab with its continuation regarding: a) the change in the asthma control test (ACT) score at 6, 12 and 24 months compared to baseline b) the time between baseline to loss of control defined with a reduction of 5 points or more on ACT score (compared to baseline) c) the time between baseline to the first exacerbation d) the number of exacerbations within 24 months e) the proportion of patients with ≥ 1 exacerbation and ≥ 1 severe exacerbation at 6, 12 and 24 months, The proportion of patients with resumption of dupilumab in the interventional group (stopping dupilumab) at 6, 12 and 24 months, The proportion of patients with AE or SAE in both groups	—

Measure

Time frame

To compare stopping dupilumab with its continuation regarding: a) the change in the asthma control test (ACT) score at 6, 12 and 24 months compared to baseline b) the time between baseline to loss of control defined with a reduction of 5 points or more on ACT score (compared to baseline) c) the time between baseline to the first exacerbation d) the number of exacerbations within 24 months e) the proportion of patients with ≥ 1 exacerbation and ≥ 1 severe exacerbation at 6, 12 and 24 months, The proportion of patients with resumption of dupilumab in the interventional group (stopping dupilumab) at 6, 12 and 24 months, The proportion of patients with AE or SAE in both groups

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Countries

France

Outcome results

None listed