the BIRDIE trial

2023-505839-12-01 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 26 Feb 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 80
Countries 1
Sites 1

Severe asthma

1. To evaluate if it is possible to extend the dosing interval of mepolizumab, driven by eosinophil levels as biomarker in patients with severe eosinophilic asthma without loss of asthma control 2. To evaluate if it is possible to extend the dosing interval of dupilumab, driven by FeNO as biomarker in patients with se…

Key facts

Sponsor
Sint Franciscus Vlietland Groep Stichting
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
26 Feb 2024 → ongoing
Decision date (initial)
2023-09-26
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

1. To evaluate if it is possible to extend the dosing interval of mepolizumab, driven by eosinophil levels as biomarker in patients with severe eosinophilic asthma without loss of asthma control
2. To evaluate if it is possible to extend the dosing interval of dupilumab, driven by FeNO as biomarker in patients with severe T2-high asthma without loss of asthma control

Conditions and MedDRA coding

Severe asthma

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2023-505839-12-00 BIomarker-dRiven Dosing Interval Extension of biologics in asthma (the BIRDIE trial) Sint Franciscus Vlietland Groep Stichting

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Severe asthma as primary indication for treatment with mepolizumab (one dose every 4 weeks) or dupilumab (one dose every 2 weeks) for the last 6 months.
  2. Stable asthma (an ACQ <1.5 and no severe asthma exacerbations) for at least 6 months.
  3. Sufficient understanding of the Dutch language

Exclusion criteria 5

  1. Treatment with maintenance OCS, defined as treatment with OCS during 14 or more subsequent days, in the last 6 months
  2. Treatment with immunosuppressants (other than mepolizumab, dupilumab or corticosteroids) in the last 6 months
  3. Treatment with, or switching between, other biologics than the drug of interest in the 6 months before inclusion.
  4. Pulmonary disease(s) other than asthma (including EGPA)
  5. Pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The main study endpoint is the number of injections in the mepolizumab and in the dupilumab intervention group compared to the control groups during the follow-up period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Dupixent 100 mg solution for injection in pre-filled syringe

PRD10117159 · Product

Active substance
Dupilumab
Substance synonyms
REGN668, SAR231893
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
300 mg milligram(s)
Max total dose
300 mg milligram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
D11AH05 — -
Marketing authorisation
EU/1/17/1229/022
MA holder
SANOFI WINTHROP INDUSTRIE
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Nucala 100 mg powder for solution for injection

PRD3513474 · 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
100 mg milligram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03DX09 — -
Marketing authorisation
EU/1/15/1043/001
MA holder
GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Franciscus Vlietland Groep Stichting

4 Total trials 3 Recruiting
Academic / Non-commercial
Sponsor organisation
Sint Franciscus Vlietland Groep Stichting
Address
Kleiweg 500
City
Rotterdam
Postcode
3045 PM
Country
Netherlands

Scientific contact point

Organisation
Sint Franciscus Vlietland Groep Stichting
Contact name
Wetenschapsbureau

Public contact point

Organisation
Sint Franciscus Vlietland Groep Stichting
Contact name
Wetenschapsbureau

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruiting 80 1
Rest of world — 0 —

Investigational sites

Netherlands

1 site · Ongoing, recruiting
Sint Franciscus Vlietland Groep Stichting
Pharmacy, Kleiweg 500, 3045 PM, Rotterdam

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2024-02-26 2024-02-26

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Research protocol BIRDIE clean dd 12-02-2025 4
Protocol (for publication) D1_Research protocol BIRDIE track changes dd 12-02-2025 4
Protocol (for publication) D1_Research protocol BIRDIE trial redacted 6
Protocol (for publication) D1_Research protocol BIRDIE trial track changes 6
Recruitment arrangements (for publication) K1_Recruitment Procedure NL 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_dupilumab_NL 3
Subject information and informed consent form (for publication) L1_SIS and ICF adults_dupilumab_NL 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_dupilumab_NL track changes 4
Subject information and informed consent form (for publication) L1_SIS and ICF adults_dupilumab_NL track changes 3
Subject information and informed consent form (for publication) L1_SIS and ICF adults_dupilumab_NL track changes 2.2
Subject information and informed consent form (for publication) L1_SIS and ICF adults_dupilumab_NL track changes 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_dupilumab_NL v2 2 2.2
Subject information and informed consent form (for publication) L1_SIS and ICF adults_mepolizumab_NL 4
Subject information and informed consent form (for publication) L1_SIS and ICF adults_mepolizumab_NL 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_mepolizumab_NL 3.2
Subject information and informed consent form (for publication) L1_SIS and ICF adults_mepolizumab_NL track changes 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_mepolizumab_NL track changes 3.2
Subject information and informed consent form (for publication) L1_SIS and ICF adults_mepolizumab_NL track changes 4
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Dupixent dupilumab 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Nucala mepolizumab 1
Synopsis of the protocol (for publication) D1_ Protocol synposis_NL 3

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-06-23 Netherlands Acceptable
2023-09-26
 2023-09-26
2 SUBSTANTIAL MODIFICATION SM-1 2025-10-17 Netherlands Acceptable
2025-12-03
 2025-12-03

Related clinical trials