Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorR-Pharm International, LLC

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

138 Participants
are divided into 2 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