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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Lung Diseases, Interstitial

In brief

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).

Key facts

Study ID

NCT06440746

Run by

R-Pharm International, LLC

People needed

138

Starts

2023-08-23

Expected to finish

2028-12-25

Last updated by the study team

2024-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient has signed the Informed Consent Form
• Progressive fibrosing ILD confirmed by high-resolution computed tomography (HRCT) documented evidence of >10% lung tissue affected at Screening:
• A. Patients with an usual interstitial pneumonia (UIP) -like radiological pattern described in the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines for the management Idiopathic pulmonary fibrosis (IPF) that do not have an identified primary condition
• В. Patients with progressive interstitial pneumonia with autoimmune features (IPAF) as defined in the American Thoracic Society/European Respiratory Society Statement, 2015
• С. Patients with progressive lung fibrosis associated with different disorders (c) such as systemic connective tissue diseases, chronic fibrosin hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP) or sarcoidosis.
• Disease progression will be established based on a combination of criterion (I)(a) and criterion (II) or criterion (III)(b)
• I. Clinically significant decrease in FVC% predicted defined as absolute decrease of ≥ 5% within 12 months prior to screening or an absolute decrease DLCO (corrected for hemoglobin) of ≥10% predicted within 12 months prior to screening.
• II. Worsening respiratory symptoms without an alternative explanation within 12 months prior to screening.
• III. Increased area affected with fibrosis on chest HRCT (b) (according to the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines) within 24 months prior to screening.
• 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.
• ILD duration of no more than 8 years from the onset of respiratory symptoms by the date screening begins.
• Elevated acute phase reactants at screening not related to other causes:
• C-reactive protein level ≥6 mg/l or Erythrocyte Sedimentation Rate (ESR) ≥28 millimeters per hour (mm/hour).
• FVC ≥ 45% and ≤ 80% predicted at screening.
• Non-Inclusion Criteria:
• Hemoglobin-corrected DLCO < 30% predicted at screening.
• Significant airway obstruction at screening defined as a Forced expiratory volume in 1 second (FEV1) / FVC ratio of <70 %.
• Use of interleukin-6(IL-6 )inhibitors or IL-6 receptor inhibitors except for CoronaVirus Disease2019 (COVID-19) treatment. If those medications are used to treat COVID-19, the last administration of IL-6 inhibitors or IL-6 receptor inhibitors must have occurred at least 6 months prior to screening.
• Administration of rituximab within less than 12 months prior to screening.
• Treatment with systemic glucocorticosteroids (GCS) at >10 mg/day calculated for prednisolone; or a change in the dose of GCS within 4 weeks before/during the screening period; or planned dose changes during the trial.
• A history of bone marrow transplantation, total lymphoid tissue irradiation, or administration of ablative ultra-high doses of cyclophosphamide.
• Initiation of mycophenolate mofetil or antifibrotic agents (for patients receiving mycophenolate mofetil and/or antifibrotics at study entry) less than 12 months prior to screening.
• If a patient has been taking antifibrotic drugs for <12 months and ≥6 months, and the spirometry/Diffusion Capacity Of The Lungs For Carbon Monoxide (DLCO) used to assess progression was performed within ±2 weeks of actually starting antifibrotic drugs, the patient may be included in the study

Where it is running

• Regional Clinical Hospital Regional state budgetary healthcare institution — Barnaul, Russia (enrolling)
• Regional Clinic Hospital№3 — Chelyabinsk, Russia (enrolling)
• Chelyabinsk Regional Clinical Hospital — Chelyabinsk, Russia (enrolling)
• State budgetary healthcare institution of the Leningrad region "Gatchina Clinical Interdistrict Hospital" — Gatchina, Russia (enrolling)
• LLC" Medsi-Izhevsk" — Izhevsk, Russia (enrolling)
• LLC "Scientific Research Medical Complex "Your Health" — Kazan', Russia (enrolling)
• Kuzbass Clinical Hospital Emergency Medical Care named after Podgorbunsky M.A — Kemerovo, Russia (enrolling)
• State Budgetary Healthcare Institution Research Institute-Karpaty Clinical Hospital No. 1 named after prof. S.V. Ochapovsky — Krasnodar, Russia (enrolling)
• City Clinical Hospital named after Davydovsky I.V. — Moscow, Russia (enrolling)
• GBUZ Moscow Clinical Scientific Center named after Loginov MHD — Moscow, Russia (enrolling)
• Scientific Research Institute of Reumatology named after Nasonova V.A — Moscow, Russia (enrolling)
• Moscow City Polyclinic №52 — Moscow, Russia (enrolling)
• Clinical Hospital №4 of Sechenov University — Moscow, Russia (enrolling)
• Clinical Hospital №3 of Sechenov University — Moscow, Russia (enrolling)
• State Budgetary Healthcare Institution of Moscow City "City Clinical Hospital №52" of the Moscow City Health Department", Consultative and diagnostic department №2 — Moscow, Russia (enrolling)
• State Budgetary Healthcare Institution of Moscow City "City Clinical Hospital №52" of the Moscow City Health Department" — Moscow, Russia (enrolling)
• FSBEI HE "Russian University of Medicine", MoH of Russia — Moscow, Russia (enrolling)
• Moscow Regional Research and Clinical Institute "MONIKI" — Moscow, Russia (enrolling)
• Federal Research Center Institute of Cytologyand Genetics,Siberian Branch of Russian Academy of Sciences — Novosibirsk, Russia (enrolling)
• Republican Hospital named after V.A. Baranov — Petrozavodsk, Russia (enrolling)
• Saint-Petersburg State Research Institute of Phthisiopulmonology of the Ministry of Healthcare of the Russian Federation — Saint Petersburg, Russia (enrolling)
• LLC"Energy of Health" — Saint Petersburg, Russia (enrolling)
• Medical Center "Interleukin" — Saint Petersburg, Russia (enrolling)
• City Multidisciplinary Hospital №2-Expert Center in the field of Pulmonology — Saint Petersburg, Russia (enrolling)
• LLC"Kurator" — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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