Early access
Sign in
Not yet taking people in NetherlandsPhase 4

Testing longer gaps between biologic injections in severe asthma

Tests whether adults with severe asthma can safely take biologic treatment at longer intervals.

Key facts

Who runs it
Amsterdam UMC Stichting
Where
Amsterdam, NetherlandsSee the site
Registry title
BIOlogical treatment GRAdual Interval Longing in severe Asthma (BIO-GRAIL)
Status
Not yet recruiting
Phase
Phase 4
People taking part
142 people, planned
Started
1 Mar 2026
Expected to end
29 Feb 2028
Type of study
Interventional
Record updated
5 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe asthma whose asthma is well controlled on a biologic medicine, to test slowly lengthening the time between doses.

Age
18 years or older
Sex
All sexes can join
Disease stage
Severe asthma that is well controlled: 0 or 1 asthma attack in the past 12 months and an ACQ score below 2.0
Earlier treatment
Taking a biologic medicine (mepolizumab, reslizumab, benralizumab, dupilumab or tezepelumab) for more than 12 months
Biomarker or test result
Blood eosinophil count of 0.3 or lower (x10^9/L) for anti-IL-5(R) medicines or tezepelumab, and 1.5 or lower (x10^9/L) for dupilumab

Main reasons for not taking part

  • Uncontrolled asthma (more than 1 attack in the past 12 months or ACQ above 2.0)
  • Pregnancy
  • Plans to become pregnant within the next 12 months
  • Dose intervals already lengthened beyond the approved schedule at the patient's request
  • Cannot speak, read and write Dutch or English

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Netherlands

  • Amsterdam UMC StichtingAmsterdam, NetherlandsNot yet recruiting

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
BIOlogical treatment GRAdual Interval Longing in severe Asthma (BIO-GRAIL)
Plain-language title
Testing longer gaps between biologic injections in severe asthmaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
5 June 2026