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RECRUITING
NCT05651841
PHASE3

REVErsing Airway Remodelling With Tezepelumab

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

The aim of this protocol is to perform a first randomized controlled trial evaluating how Tezepelumab affects the bronchial morphology (and computed tomographic variables in general) of asthmatic patients. In parallel, the investigators also hope to reproduce clinical benefits and perform a transcriptomic study that will juxtapose changes in genetic expression with changes in bronchial morphology and inflammatory signatures. The general hypothesis is that tezepelumab treatment is capable of at least partially reversing bronchial remodelling as detected on computed-tomographic (CT) scans. The investigators also expect such reversal to occur within a unique physiological repair environment that will be reflected by transcriptomic profiles

Official title: REVErsing Airway Remodelling With Tezepelumab : a Protocol for a Double-blind Randomized Controlled Trial for Patients With Asthma

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-03-27

Completion Date

2026-06-01

Last Updated

2024-02-28

Healthy Volunteers

No

Interventions

DRUG

Tezepelumab

Tezepelumab is supplied as a sterile, single-use, preservation-free, clear, colourless to slightly yellow liquid for subcutaneous administration in accessorized pre-filled syringes (APFS). Injections will be performed by study staff (doctors or nurses) during face-to-face study visits in participating centres. Subcutaneous injections are performed in a different body-part following the suggested rotation diagram.

OTHER

placebo

APFS containing analogous placebo identical in appearance: Injections will be performed by study staff (doctors or nurses) during face-to-face study visits in participating centres. Subcutaneous injections are performed in a different body-part following the suggested rotation diagram.

Locations (12)

CHU Dijon

Dijon, France

CHU Grenoble Alpes La Tronche

Grenoble, France

APHP Bicêtre

Le Kremlin-Bicêtre, France

CHRU Lille

Lille, France

Hôpital de la Croix Rousse

Lyon, France

Hôpital Nord Marseille

Marseille, France

CHU de Montpelier

Montpellier, France

APHP Bichat

Paris, France

Hôpital Foch

Paris, France

Hôpital Haut-Lévêque

Pessac, France

CHRU Strasbourg

Strasbourg, France

CHU Toulouse

Toulouse, France