NCT06440746

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

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase 2/3 Study of Efficacy and Safety of Olokizumab in Subjects With Progressive Fibrosing Interstitial Lung Diseases

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: R-Pharm International, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a phase 2/3 study with double-blind parallel-group adaptive design. The study will include the following periods: 1. Screening period (4 weeks) Screening period (before the first administration of the test drug). Before being included in the study, patients will be provided with complete information about this clinical trial and signs the Informed consent Form (IF). After that the researcher will decide whether or not the patient can be randomized into the study. 2. Double-blind Treatment period (48 weeks). Following the completion of a Treatment period, all patients will be enrolled in Follow-up Period (FU). 3. Follow-up Period (24 weeks). During the FU Period, patients will visit study sites after 4,12 and 24 weeks after the end of the Treatment Period to complete FU-1 (Week 52), FU-2 (Week 60) and FU-3 (Week 72) visits. The overall study duration for the patients will be approximately 76 weeks (including the 4 weeks screening period) The analysis will be conducted in two sequential steps: * the interim analysis after 61 percent (%) of patients have completed the Treatment period (not including the FU period) * the final analysis when all patients have completed all periods (the Treatment and the FU periods).

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)	Olokizumab is a sterile solution for subcutaneous injection in a 2-mL clear Type I glass vial, containing a target fill volume of 0.5 mL (for withdrawal of no less than 0.4 mL) of olokizumab drug substance at a concentration of 160 milligrams (mg)/mL.
DRUG	SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL	Placebo (sodium chloride 0.9 %) does not contain any active pharmaceutical ingredients. Placebo will be supplied in 2-mL, 5-mL, or 10-mL ampoules made of low-density polyethylene or polypropylene.

Timeline

• Start date: 2023-08-23
• Primary completion: 2027-04-09
• Completion: 2028-12-25
• First posted: 2024-06-04
• Last updated: 2024-11-19

Locations

33 sites across 1 country: Russia