TEZEPELUMAB for Progressive pulmonary fibrosis (interstitial lung disease) with eosinophilia | Idiopathic pulmonary fibrosis | Interstitial pulmonary fibrosis

Inclusion criteria

• {"criterion_text":"- Signed written informed consent form\n- Adult patients ≥ 18 years, female and male\n- 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\n- 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\n- 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)\n- 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\n- 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)\n- 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.\n- 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 criteria

• {"criterion_text":"- Oral corticosteroid dose >10mg/d\n- Unstable cardiovascular disease\n- 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.\n- Pregnant or breastfeeding women\n- Receipt of live attenuated vaccines 30 days prior to the date of randomization\n- 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\n- Concurrent enrolment in another clinical study involving an IP.\n- anti-IL5-(Receptor), anti-IL4 or anti-IL13 biological therapy within the past 4 months\n- Omalizumab therapy\n- Rituximab therapy within the past 9 months\n- JAK-inhibitors within the past 4 weeks\n- Cyclophosphamide within the past 6 months\n- Current smoker or former smoker <24 weeks\n- Severe lung functional impairment according to the treating physician interfering substantial with participation in the trial\n- Known active malignancy or high clinical suspicion of malignant disease"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change in number of eosinophils in differential blood cell count (absolute numbers) between baseline and 24 weeks of treatment compared to placebo."}

Secondary endpoints

• {"endpoint_text":"- change from baseline in forced vital capacity (FVC)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured by change from baseline in K-BILD or QPF questionnaire scores at 20 weeks."}
• {"endpoint_text":"- Time to decrease of FVC > 5% from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to decrease of DLCO > 10% from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first acute exacerbation of underlying interstitial lung disease","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first all-cause hospitalization","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to all-cause mortality","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to composite endpoint of disease progression (defined as decline of FVC ≥ 5% or DLCOcSB ≥ 10% from baseline or death from any cause)","definition_or_measurement_approach":"Composite endpoint defined as decline of FVC ≥ 5% or DLCOcSB ≥ 10% from baseline or death from any cause."}
• {"endpoint_text":"- Change from baseline in total lung capacity (TLC)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from baseline in DLCOcSB","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from baseline in DLCOc/VA","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from baseline in capillary pO2","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change form baseline in 6-minute walking test distance","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from baseline in Quality of life in patients with idiopathic pulmonary fibrosis (QPF) Questionnaire score. Key outcome measure: difference placebo vs week 24.","definition_or_measurement_approach":"Key outcome measure: difference placebo vs week 24."}
• {"endpoint_text":"- Need to increase corticosteroid dose","definition_or_measurement_approach":""}
• {"endpoint_text":"- Need to increase dose of disease-modifying antirheumatic drugs","definition_or_measurement_approach":""}
• {"endpoint_text":"- Need to initiate new disease-modifying antiheumatic drugs","definition_or_measurement_approach":""}

Germany

Latest Decision Or Authorization Date

27-10-2025

Number Of Sites

5

Number Of Participants

39

Primary sponsor

Full Name

Philipps-Universitaet Marburg

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR","duties_or_roles":"code: 14","organisation_type":"Hospital/Clinic/Other health care facility"}