SYF2897d056177d438d8b6666635b09b122Registry ID: 2024-510884-51-00|SuspendedPhase 2
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interventional
N/A
1 country
5
To determine the efficacy of Tezepelumab to decrease peripheral blood eosinophilia when compared to placebo after 24 weeks in progressive pulmonary fibrosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 12, 2024
Actual (reported)Primary endpoint: Change in blood cell count (absolute numbers) after 24 weeks Primary outcome measure: Change in number of eosinophils in differential blood cell count (absolute numbers) between baseline and 24 weeks of treatment compared to placebo.
change from baseline in forced vital capacity (FVC)
Change from baseline in King’s Brief Interstitial Lung Disease Questionnaire (K-BILD) or Quality of life in patients with idiopathic pulmonary fibrosis (QPF) Questionnaire at 20 weeks
Time to decrease of FVC > 5% from baseline
Time to decrease of DLCO > 10% from baseline
Time to first acute exacerbation of underlying interstitial lung disease
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Tezspire 210 mg solution for injection in pre-filled syringe
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
TEZEPELUMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Tezspire 210 mg solution for injection in pre-filled syringe
Named ingredient: tezepelumab
View registry recordTEZEPELUMAB
Named ingredient: tezepelumab
View registry recordLungenClinic Grosshansdorf GmbH
Grosshansdorf, 22927, Germany
Medizinische Hochschule Hannover
Hannover, 30625, Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Essen, 45239, Germany
Project Management
First Submitted
September 12, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD
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Klinikum der Universitaet Muenchen AöR
Munich, 81377, Germany
Vivantes Netzwerk fuer Gesundheit GmbH
Berlin, 12351, Germany