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2025-524741-28-00Not yet recruitingPhase 4

BIOlogical treatment GRAdual Interval Longing in severe Asthma (BIO-GRAIL)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Jun 2026

Next steps

Brief summary (registry, in English)

To evaluate the feasibility and safety of gradual interval prolonging of biologics during ~1 year in patients with severe asthma

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
142 (estimated)
First submitted
19 Feb 2026
Start date
1 Mar 2026
Lead sponsor
Amsterdam UMC Stichting
Diseases
Asthma
EU CT number
2025-524741-28-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 142
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other

  • Uncontrolled asthma (>1 exacerbation in the past 12 months or ACQ > 2.0)
  • Pregnancy
  • Intention to become pregnant within the next 12 months
  • Biologic administration intervals already prolonged beyond the approved regimen according to the SmPC at the patient’s request
  • Inability to understand and communicate in Dutch or English, both spoken and written

Who the study is looking for

  • Receiving biological treatment (mepolizumab, reslizumab, benralizumab, dupilumab, or tezepelumab) for more than 12 months
  • ≥18 years of age
  • 0 or 1 exacerbation in the past 12 months
  • Baseline ACQ < 2.0
  • Blood eosinophil count ≤0.3 +10^9/L for anti-IL-5(R)/Tezepelumab, ≤1.5 +10^9/L for Dupilumab

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC StichtingAmsterdamNetherlandsNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.