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Evaluating Olokizumab for Progressive Fibrosing 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

Phase2; Phase3 Interventional R-Pharm · NCT06440746

This study is testing if a new injection called olokizumab can help people with progressive fibrosing lung diseases breathe better and improve their overall health compared to a placebo.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment138 (estimated)
Ages18 Years and up
SexAll
SponsorR-Pharm Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide, olokizumab
Locations33 sites (Barnaul and 32 other locations)
Trial IDNCT06440746 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of olokizumab, a medication administered via subcutaneous injections, compared to a placebo in patients suffering from progressive fibrosing interstitial lung diseases (ILD). The study follows a double-blind, parallel-group adaptive design and includes a screening period, a treatment period lasting 48 weeks, and a follow-up period of 24 weeks. Patients will be monitored for changes in lung function and overall health throughout the study duration of approximately 76 weeks.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with progressive fibrosing ILD, confirmed by high-resolution computed tomography, and who meet specific inclusion criteria.

Not a fit: Patients with stable interstitial lung diseases or those not meeting the criteria for progressive fibrosing ILD may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with progressive fibrosing ILD.

How similar studies have performed: Other studies have explored treatments for interstitial lung diseases, but the specific use of olokizumab in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. The patient has signed the Informed Consent Form
2. 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.
   1. 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.
   2. 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.
   3. stable course of the main disease not requiring a change in maintenance treatment.
3. ILD duration of no more than 8 years from the onset of respiratory symptoms by the date screening begins.
4. 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).
5. FVC ≥ 45% and ≤ 80% predicted at screening.

Non-Inclusion Criteria:

1. Hemoglobin-corrected DLCO \< 30% predicted at screening.
2. Significant airway obstruction at screening defined as a Forced expiratory volume in 1 second (FEV1) / FVC ratio of \<70 %.
3. 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.
4. Administration of rituximab within less than 12 months prior to screening.
5. 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.
6. A history of bone marrow transplantation, total lymphoid tissue irradiation, or administration of ablative ultra-high doses of cyclophosphamide.
7. 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
8. Discontinuation of previously prescribed antifibrotic agents within 6 months prior to screening (for patients not receiving antifibrotic drugs at study entry).
9. Participation in any other clinical trial less than 30 days prior to the baseline assessment or less than 5 half-lives of the medication examined in another clinical trial, whichever is longer.
10. Laboratory abnormalities as follows:

    * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase(AST) ≥ 1.5×Upper Limit Normal (ULN)
    * Platelet count \<100×10\^9/litre (l) (\<100000/cubic millimetre (mm\^3)
    * Leukocyte count \<3.5×10\^9/l
    * Absolute neutrophil count \<2000×10\^6/l (\<2000/mm\^3).
11. Concurrent malignancy or a history of malignancy within the last 5 years.
12. Any acute infection at screening or exacerbation of a chronic infection, any infection requiring oral antibiotics or antivirals within 4 weeks prior to screening, injection of antimicrobial agents within 6 weeks before randomization, severe or recurrent infections requiring hospital admission within 6 months before randomization.
13. Patients with evidence of disseminated herpes zoster infection, herpes zoster with encephalitis, meningitis, or other forms of herpes zoster infection that do not resolve without treatment and occurred within 6 months prior to screening.
14. Evidence of any other chronic infection (including sepsis, invasive fungal infection, histoplasmosis, osteomyelitis) which, in the opinion of the Investigator, may increase the risk of infectious complications during the trial.
15. Patients with diverticulitis or other symptomatic gastrointestinal diseases that may lead to perforation, including such history (for example, diverticulitis, gastrointestinal perforation, ulcerative colitis).
16. Women of child-bearing potential or men whose partners are women of child-bearing potential who do not want to use highly effective methods of contraception during the trial and for at least 3 months after the last administration of the investigational product.
17. Known hypersensitivity to OKZ or any other component of the product or placebo.
18. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
19. Other protocol-defined non-inclusion criteria apply.

Where this trial is running

Barnaul and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung Diseases, InterstitialProgressive Fibrosing Interstitial Lung DiseasesOlokizumabForced vital capacity
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.