Withdrawal of Dupilumab in Severe Asthma
WIDUSA
WIthdrawal of DUpilumab in Severe Asthma: a Randomized Non-inferiority-controlled Trial
2 other identifiers
interventional
205
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2025
Longer than P75 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 10, 2025
CompletedStudy Start
First participant enrolled
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
February 10, 2025
February 1, 2025
2.7 years
November 19, 2024
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Strategy failure
Proportion of patients with strategy failure defined as patients with an annualised number of asthma exacerbations ≥ 2 and/or dupilumab resume or switch to another biologic within 24 months following randomisation
24 months
Secondary Outcomes (12)
Change in asthma control test score
6, 12 and 24 months
Resumption of dupilumab
6, 12 and 24 months
Adverse events or serious adverse events
24 months
Time to loss of control
24 months
First exacerbation
24 months
- +7 more secondary outcomes
Study Arms (2)
Stopping dupilumab
EXPERIMENTALThe experimental strategy comprises stopping dupilumab with no dose-reducing or interval of time-increasing strategy from the day of inclusion/randomisation
Dupilumab continuation
NO INTERVENTIONDupilumab continuation at the same dose and same interval as baseline
Interventions
Stopping dupilumab with no dose-reducing or interval of time-increasing strategy
Eligibility Criteria
You may qualify if:
- Adult patients ≥ 18 years old
- Treated with dupilumab for at least 36 months for severe asthma
You may not qualify if:
- Patients who refuse to discontinue dupilumab, for any reason
- Patients with Forced expiratory volume in one second ≤ 30% of predicted values
- Patients treated by an oral corticosteroid dose ≥ 10 mg/day (in prednisone equivalent)
- Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, or a planned switch to another biologic indicated in severe asthma
- Patients who have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis
- Active smoking
- Pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
CHU de Toulouse
Toulouse, CHU de Toulouse, 31059, France
CHU Amiens-Picardie
Amiens, France, 80480, France
CHR d'Angers
Angers, France, 49100, France
CH de Bayonne
Bayonne, France, 64100, France
CHU de Besançon
Besançon, France, 25000, France
CHU de Brest
Brest, France, 29200, France
CHU de Caen
Caen, France, 14000, France
CH de Cannes
Cannes, France, 06400, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000, France
CHI de Créteil
Créteil, France, 94000, France
CHU de Dijon
Dijon, France, 21000, France
CH Annecy Genevois
Epagny-Metz-Annecy, France, 74370, France
CHU Grenoble-Alpes
La Tronche, France, 38700, France
Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, France, 94270, France
CH Le Mans
Le Mans, France, 72037, France
Institut Coeur Poumon, CHU de Lille
Lille, France, 59000, France
Hôpital Croix Rousse
Lyon, France, 69004, France
Hôpital Avicenne
Paris, France, 75012, France
Hôpital Européen Georges Pompidou
Paris, France, 75015, France
Hôpital Bichât
Paris, France, 75018, France
CHU de Bordeaux
Pessac, France, 33600, France
Hôpital Lyon Sud
Pierre-Bénite, France, 69495, France
CHU de Guadeloupe
Pointe à Pitre, France, 97159, France
CHU de Reims
Reims, France, 51092, France
CH de Roubaix
Roubaix, France, 59100, France
CHU de Nantes
Saint-Herblain, France, 44800, France
Nouvel Hôpital Civil
Strasbourg, France, 67000, France
Hôpital Foch
Suresnes, France, 92150, France
Hôpital Tarbes Lourdes
Tarbes, France, 65000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent GUILLEMINAULT, MD, PhD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2024
First Posted
February 10, 2025
Study Start
April 2, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
February 10, 2025
Record last verified: 2025-02