About this trial
The purpose of this study is to evaluate efficacy and safety of olokizumab (OKZ) compared to placebo in patients progressive fibrosing Interstitial lung diseases (ILD).
Eligibility criteria
Qualifiers
The patient has signed the Informed Consent Form
To assess this criterion (I), patient's pulmonary function test (PFT) results obtained within 12 months prior to screening must available. If data from multiple PFTs are available, the earliest results must be used for assessment.
Patients' results of at least one chest HRCT investigation performed no earlier than 24 months before randomization must be available for review. If results of multiple HRCT examinations are available, patient eligibility must be based on the earliest results.
stable course of the main disease not requiring a change in maintenance treatment.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)
- SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL
Treatment groups
Sponsors and collaborators
R-Pharm International, LLC
Lead sponsor
R-Pharm
Collaborator
Exacte Labs LLC
Collaborator
Data Management 365
Collaborator
Keystat, LLC
Collaborator