Tezepelumab (Anti-TSLP-mab) in progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia - A prospective two-armed, phase II clinical multicentre randomized, placebo-controlled (2:1), blinded with open-label extension trial (TEFIBEOS)

Trial details

Who runs it

Philipps-Universitaet Marburg

Trial code

EU 2024-510884-51-00

Record updated

2026. május 29.

Original description

To determine the efficacy of Tezepelumab to decrease peripheral blood eosinophilia when compared to placebo after 24 weeks in progressive pulmonary fibrosis.Read full original descriptionShow less

To determine the efficacy of Tezepelumab to decrease peripheral blood eosinophilia when compared to placebo after 24 weeks in progressive pulmonary fibrosis.

Inclusion: Signed written informed consent form; Adult patients ≥ 18 years, female and male; Patients with a diagnosis of IPF or a diagnosis of progressive pulmonary fibrosis due to chronic, eosinophilic pneumonia with fibrotic phenotype, fibrotic hypersensitivity pneumonitis / exogen allergic alveolitis or CTD-associated ILD with progressive fibrotic behaviour or other progressive fibrotic Interstitial lung diseases; receiving antifibrotic therapy at a stable dose (either nintedanib or pirfenidone) for at least 2 months which was initiated due to a diagnosis of IPF or progressive pulmonary fibrotic behavior of non-IPF ILD at the discretion of the treating physician; In non-IPF patients receiving immunosuppressive medication, dose must be stable for at least 3 months (except for prednisolone, where a dose of ≤ 10mg/d for at least 4 weeks is allowed); blood eosinophilia with an absolute count of ≥ 150/µL at screening and/or BAL eosinophilia of ≥10% within the last 12 months prior to screening; Willingness of women of childbearing potential (WOCBP) to use highly effective birth control methods from the date of consent through the post study follow up examination at week 56 (According to CTFG recommendation); A negative result in pregnancy test and additional pregnancy testing prior to each administration of the IMP should be performed during the duration of the trial and at the post study follow up visit at week 56; Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 12 weeks after receipt of the final dose of IP.

Exclusion: Oral corticosteroid dose >10mg/d; Receipt of live attenuated vaccines 30 days prior to the date of randomization; Concurrent enrolment in another clinical study involving an IP; anti-IL5-(Receptor), anti-IL4 or anti-IL13 biological therapy within the past 4 months; Omalizumab therapy; Rituximab therapy within the past 9 months; JAK-inhibitors within the past 4 weeks; Unstable cardiovascular disease; Subjects with untreated systemic helminth parasitic infections or recurrent or active current bacterial, viral or fungal infection (excluding fungal infections of the nails), for example but not limited to active hepatitis B and C, typical or atypical mycobacteriosis or herpes zoster infections; Known history of sensitivity to any component of the IP formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation; Severe lung functional impairment according to the treating physician interfering substantial with participation in the trial; Known active malignancy or high clinical suspicion of malignant disease; Pregnant or breastfeeding women; Cyclophosphamide within the past 6 months; Current smoker or former smoker <24 weeks.

EU CTIS 2024-510884-51-00