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

NCT06440746 | Recruiting Phase 2 DMC

• 1 other identifier: CL04041109
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 33

Brief 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

Keywords

Progressive Fibrosing Interstitial Lung Diseases; Olokizumab; Forced vital capacity

Outcome Measures

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.

  48 weeks

Secondary Outcomes (13)

• Change in FVC from baseline

  24, 48 weeks.

• Change in FVC.% predicted

  24,48 weeks

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

  48 weeks

• Number of patients (in %) with improved pulmonary function

  48 weeks

• Change of Diffusing capacity of the lungs for carbon monoxide (DLCO)

  24,48 weeks

Study Arms (2)

Arm1:OKZ 64 mg q4w

EXPERIMENTAL

SC injections of OKZ 64 mg q4w

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

Arm2:Placebo

PLACEBO COMPARATOR

SC injections of Placebo q4w

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

Interventions

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.

Also known as: Artlegia

Arm1:OKZ 64 mg q4w

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.

Arm2:Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• R-Pharm International, LLC: lead
• R-Pharm: collaborator
• Exacte Labs LLC: collaborator
• Data Management 365: collaborator
• Keystat, LLC: collaborator

Study Sites (33)

Regional Clinical Hospital Regional state budgetary healthcare institution

Barnaul, 656024, Russia

RECRUITING

Regional Clinic Hospital№3

Chelyabinsk, 454001, Russia

RECRUITING

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, 454048, Russia

RECRUITING

State budgetary healthcare institution of the Leningrad region "Gatchina Clinical Interdistrict Hospital"

Gatchina, 188300, Russia

RECRUITING

LLC" Medsi-Izhevsk"

Izhevsk, 426011,, Russia

RECRUITING

LLC "Scientific Research Medical Complex "Your Health"

Kazan', 420094, Russia

RECRUITING

Kuzbass Clinical Hospital Emergency Medical Care named after Podgorbunsky M.A

Kemerovo, 650000, Russia

RECRUITING

State Budgetary Healthcare Institution Research Institute-Karpaty Clinical Hospital No. 1 named after prof. S.V. Ochapovsky

Krasnodar, 350086, Russia

RECRUITING

City Clinical Hospital named after Davydovsky I.V.

Moscow, 109240, Russia

RECRUITING

GBUZ Moscow Clinical Scientific Center named after Loginov MHD

Moscow, 111123, Russia

RECRUITING

Scientific Research Institute of Reumatology named after Nasonova V.A

Moscow, 115522, Russia

RECRUITING

Moscow City Polyclinic №52

Moscow, 117546, Russia

RECRUITING

Clinical Hospital №4 of Sechenov University

Moscow, 119048, Russia

RECRUITING

Clinical Hospital №3 of Sechenov University

Moscow, 119435, Russia

RECRUITING

State Budgetary Healthcare Institution of Moscow City "City Clinical Hospital №52" of the Moscow City Health Department", Consultative and diagnostic department №2

Moscow, 123182, Russia

RECRUITING

State Budgetary Healthcare Institution of Moscow City "City Clinical Hospital №52" of the Moscow City Health Department"

Moscow, 123182, Russia

RECRUITING

FSBEI HE "Russian University of Medicine", MoH of Russia

Moscow, 127473, Russia

RECRUITING

Moscow Regional Research and Clinical Institute "MONIKI"

Moscow, 129110, Russia

RECRUITING

Federal Research Center Institute of Cytologyand Genetics,Siberian Branch of Russian Academy of Sciences

Novosibirsk, 630117, Russia

RECRUITING

Republican Hospital named after V.A. Baranov

Petrozavodsk, 185019, Russia

RECRUITING

Saint-Petersburg State Research Institute of Phthisiopulmonology of the Ministry of Healthcare of the Russian Federation

Saint Petersburg, 139036, Russia

RECRUITING

LLC"Energy of Health"

Saint Petersburg, 194156, Russia

RECRUITING

Medical Center "Interleukin"

Saint Petersburg, 194214, Russia

RECRUITING

City Multidisciplinary Hospital №2-Expert Center in the field of Pulmonology

Saint Petersburg, 194354, Russia

RECRUITING

LLC"Kurator"

Saint Petersburg, 196240,, Russia

RECRUITING

State Healthcare Institution "Regional Clinical Hospital"

Saratov, 410053, Russia

RECRUITING

Regional state budgetary healthcare institution "Clinical Hospital No. 1"

Smolensk, 214006, Russia

RECRUITING

Regional State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 2

Tomsk, 634040, Russia

RECRUITING

Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation

Ufa, 450008, Russia

RECRUITING

State Budgetary Healthcare Institution of the Vladimir Region "Regional Clinical Hospital"

Vladimir, 600023, Russia

RECRUITING

Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No1"

Voronezh, 394066, Russia

RECRUITING

Clinical Hospital of Emergency Medical Care named after Solovyov N.V

Yaroslavl, 150003, Russia

RECRUITING

Ural research Institute of Phthisiopulmonology

Yekaterinburg, 620039, Russia

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Central Study Contacts

Yana Deloveri

CONTACT

+ 7 (968) 585-13-49; deloveri@rpharm.ru

Maria Lemak

CONTACT

+7 (903) 709-20-43; lemak@rpharm.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: August 23, 2023
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): December 25, 2028
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

RU (33)