Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
142
Countries
1
Sites
1
Severe Asthma
To evaluate the feasibility and safety of gradual interval prolonging of biologics during ~1 year in patients with severe asthma
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2026-06-05
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Amsterdam UMC
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the feasibility and safety of gradual interval prolonging of biologics during ~1 year in patients with severe asthma
Secondary objectives 8
- To evaluate the change in exacerbation frequency after gradual interval prolonging of biologics during ~1 year
- To evaluate the change in blood eosinophile count after gradual interval prolonging of biologics during ~1 year
- To evaluate the change FeNO after gradual interval prolonging of biologics during ~1 year
- To evaluate the change in lung function after gradual interval prolonging of biologics during ~1 year
- To evaluate the change in symptom scores after gradual interval prolonging of biologics during ~1 year
- To evaluate whether algorithm guided interval prolongation with ACQ, FeNO and blood eosinophil levels is equal to regular clinical care with respect to asthma control at base line.
- To evaluate severeness and cause of exacerbations during interval prolonging of biologics
- To evaluate the change in use of inhaled corticosteroids during interval prolongation as compared to baseline
Conditions and MedDRA coding
Severe Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10003555 | Asthma bronchial | 10038738 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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
Exclusion criteria 5
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Maintained asthma control after ~1 year of study participation with at least one step of interval prolongation. Asthma control is defined as not more than one additional exacerbation compared to baseline frequency during ~1 year and a ACQ < 2.0 at the last study visit. An exacerbation is defined as an acute worsening of symptoms lasting more than 48 hours, as assessed by the treating physician.
Secondary endpoints 18
- Exacerbation frequency per year.
- Blood eosinophile count in *10^9 cells per liter
- FeNO in parts per billion (ppb)
- Forced Expiratory Volume in 1 second (FEV1)
- Forced Vital Capacity (FVC)
- FEV1/FVC
- Asthma Control Questionnaire (ACQ)
- Severe Asthma Questionnaire (SAQ)
- Sino-Nasal Outcome Test (SNOT-22)
- Strict asthma control after algorithm guided interval prolongation for ~1 year. Strict asthma control is defined as ΔACQ < 0.5 and control of biomarkers.
- Detection of respiratory viruses during asthma exacerbations by PCR on nasopharyngeal swab
- Blood eosinophile count in *10^9 cells per liter during asthma exacerbations
- FeNO in parts per billion (ppb) during asthma exacerbations
- ACQ during asthma exacerbations
- SAQ during asthma exacerbations
- Dosage of Inhaled Corticosteroids (ICS)
- Inhaler technique
- 5 – item Medication Adherence Report Scale (MARS-5)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
Fasenra 30 mg solution for injection in pre-filled pen
PRD7999785 · Product
- Active substance
- Benralizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 180 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Authorised
- ATC code
- R03DX10 — -
- Marketing authorisation
- EU/1/17/1252/002
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CINQAERO 10 mg/mL concentrate for solution for infusion
PRD12931127 · Product
- Active substance
- Reslizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 36 mg/kg milligram(s)/kilogram
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Authorised
- ATC code
- R03DX08 — -
- Marketing authorisation
- PLGB 00289/2367
- MA holder
- TEVA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tezspire 210 mg solution for injection in pre-filled pen
PRD10257836 · Product
- Active substance
- Tezepelumab
- Substance synonyms
- AMG 157
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 210 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Authorised
- ATC code
- R03DX11 — -
- Marketing authorisation
- EU/1/22/1677/003
- MA holder
- ASTRAZENECA AB
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Nucala 100 mg solution for injection in pre-filled pen
PRD7486155 · Product
- Active substance
- Mepolizumab
- Substance synonyms
- SB240563
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Authorised
- ATC code
- R03DX09 — -
- Marketing authorisation
- EU/1/15/1043/003
- MA holder
- GLAXOSMITHKLINE TRADING SERVICES LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dupixent 300 mg solution for injection in pre-filled pen
PRD11975545 · Product
- Active substance
- Dupilumab
- Substance synonyms
- REGN668, SAR231893, CKD-706
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- PLGB 04425/0771
- MA holder
- AVENTIS PHARMA LTD
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dupixent 200 mg solution for injection in pre-filled pen
PRD11976211 · Product
- Active substance
- Dupilumab
- Substance synonyms
- REGN668, SAR231893, CKD-706
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 4800 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- PLGB 04425/0875
- MA holder
- AVENTIS PHARMA LTD
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- B. Hilvering
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- B. Hilvering
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 142 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC Stichting
Pulmonary Medicine, De Boelelaan 1117, 1081 HV, Amsterdam
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1-CCMO-Clinical-Trial-Protocol-BIOGRAIL version 1 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_procedure_BIOGRAIL_15022026 | 2.0 |
| Subject information and informed consent form (for publication) | F1_ACQ7 | 1 |
| Subject information and informed consent form (for publication) | F1_MARS | 1 |
| Subject information and informed consent form (for publication) | F1_SAQ | 1 |
| Subject information and informed consent form (for publication) | F1_Vragenlijst SNOT22 | 1 |
| Subject information and informed consent form (for publication) | PIF_020126 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Cinqaero | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Dupixent_071125 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Fasenra | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_NUCALA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Tezspire | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis Dutch BIO-GRAIL | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-19 | Netherlands | Acceptable 2026-06-05
|
2026-06-05 |