Fibroblast markers to tackle fibrosis in immune-mediated inflammatory diseases

Prior treatment

• Previous anti-fibrotic treatment except for end-stage ILD
• ILD: combined pulmonary fibrosis and emphysema, uncontrolled severe asthma, active malignancy (except for squamous cell carcinoma of the skin, low-risk breast cancer and low-risk prostate cancer), signs of upper or lower respitory tract symptoms during the last 6 weeks before screening or circumstances or comorbidities which interfere, by opinion of the investigator, with evaluation of the PET/CT or with the evaluation of progressive pulmonary fibrosis

Other

• Pregnancy or lactating
• Not able to provide written consent
• IBD: colorectal carcinoma or high-grade dysplasia

• ≥ 18 years of age and able to undergo a PET/CT-scan and pulmonary function test (if applicable)
• CD: endoscopically or ultrasonographically confirmed fibrostenotic disease with or without signs of active inflammation
• UC: therapy-refractory UC requiring surgery or quiescent UC with surveillance endoscopy
• SSc: SSc with active ILD or non-progressive ILD over two years or end-stage ILD
• IIM: IIM with active myositis and a clinical need to start imunosupressive agents with or without ILD
• FHP, uILD and IPF: available chest HRCT data within 12 months prior to screening (or performed at screening), minimum of 20% involvement of the lung parenchyma on HRCT and signs of fibrosis, FVC ≥ 45% predicted from normal, FEV1/FVC ≥ 0.7, DLco corrected for Hb ≥ 40% predicted from normal