Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis

Korábbi kezelés

• Currently receiving or planning to initiate treatment for IPF with agents not approved for that indication.

Más betegség

• Lower respiratory tract infection requiring antibiotics within 4 weeks of Screening or during Screening.
  • The extent of emphysema in the lungs exceeds fibrosis, based on central review of HRCT scans.
• Clinical diagnosis of any connective-tissue disease (including, but not limited to, scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the Investigator applying the recent ERS/ATS research statement [Fischer et al 2015]. Note: Serological testing is not needed if not clinically indicated.
• Disease other than IPF with a life expectancy of less than 12 weeks.
  • Additional exclusion criteria for the Translational Science Sub Study
• Participants with any contra-indication to bronchoscopy and alveolar lavage including tracheal stenosis, pulmonary hypertension, severe hypoxia, or hypercapnia.

Egyéb

• FEV1/FVC ratio <0.7 at Screening, pre-bronchodilator use.
• Need for continuous oxygen supplementation, defined as >15 hours/day.
• Acute IPF exacerbation within 6 months of Screening or during Screening.
• Patients in the sub study are not permitted to receive nintedanib or pirfenidone within 3 weeks of randomisation and throughout the Treatment period. (Note: background IPF treatment should not be stopped for the purpose of eligibility)

• Aged ≥40 to 80 years at the time of signing the informed consent.
• Diagnosis of IPF within 5 years of Screening based on the modified ATS/ERS/JRS/ALAT IPF guidelines for diagnosis and management of IPF (Raghu et al, 2018) and confirmed on independent central imaging review.
• Combination of HRCT pattern, as assessed by central reviewers, consistent with diagnosis of IPF (see the modified ATS/ERS/JRS/ALAT IPF guidelines [Raghu et al, 2018]).
• FVC % predicted ≥50% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomisation, as determined by the Investigator.
• DLco (Hb-adjusted) at screening ≥30%.
• In the main study, participants receiving treatment for IPF with nintedanib or pirfenidone are allowed if on treatment for at least 3 months and on a stable dose for at least 4 weeks prior to Screening and during Screening.
• In patients who are not on any treatment for IPF but have previously received nintedanib or pirfenidone, there needs to be a washout period ≥4 weeks prior to Screening.
• No clinically significant abnormalities, in the opinion of the investigator, in vital signs (e.g., blood pressure, pulse rate, respiration rate, oral temperature) within 28 days before first dose of IMP.