MedTrace Logo

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

NCT06440746 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-11-19

No results posted yet for this study

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).

Conditions

  • Lung Diseases, Interstitial

Interventions

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.

Sponsors & Collaborators

  • R-Pharm

    collaborator INDUSTRY

  • Exacte Labs LLC

    collaborator INDUSTRY

  • Data Management 365

    collaborator INDUSTRY

  • Keystat, LLC

    collaborator INDUSTRY

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2027-04-09
Completion
2028-12-25

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06440746 on ClinicalTrials.gov