Health TrialsbyHealthPanel

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

ConditionLung Diseases, Interstitial
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)

    Drug

    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.

  • SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL

    Drug

    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.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Arm1:OKZ 64 mg q4wExperimental treatment 1 intervention
Group B: Arm2:PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The rate of forced vital capacity (FVC)

FVC decline rate assessed over 48 weeks of therapy. FVC is the maximum amount of air that can be exhaled when blowing out as fast as possible.

Time frame
48 weeks

Secondary outcomes

1

Change in FVC from baseline

Absolute change in FVC from baseline at treatment weeks 24 and 48.

Time frame
24, 48 weeks.
2

Change in FVC.% predicted

Change in FVC% predicted from baseline at treatment weeks 24 and 48.

Time frame
24,48 weeks
3

Number of patients (in %) with a decrease in FVC

Number of patients (in %) with a decrease in FVC of ≥10 % predicted.at treatment week 48.

Time frame
48 weeks
4

Number of patients (in %) with improved pulmonary function

Number of patients (in %) with improved pulmonary function (change from baseline in FVC \>0% predicted.

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

R-Pharm International, LLC

Lead sponsor

R-Pharm

Collaborator

Exacte Labs LLC

Collaborator

Data Management 365

Collaborator

Keystat, LLC

Collaborator

Source ClinicalTrials.gov
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