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Lung Diseases, InterstitialPhase 2/3NCT06440746

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

A Phase 2/3 study testing Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL) in people with Lung Diseases, Interstitial, run by R-Pharm International, LLC at 33 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Diseases, Interstitial
What is being tested?
Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
33 sitesRussia
Study dates
23 Aug 2023to 25 Dec 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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)
Show all 41Show fewer
  • 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.
  • Worsening respiratory symptoms without an alternative explanation within 12 months prior to screening.
  • 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
  • Discontinuation of previously prescribed antifibrotic agents within 6 months prior to screening (for patients not receiving antifibrotic drugs at study entry).
  • 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.
  • 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).
  • Concurrent malignancy or a history of malignancy within the last 5 years.
  • 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.
  • 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.
  • 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.
  • Patients with diverticulitis or other symptomatic gastrointestinal diseases that may lead to perforation, including such history (for example, diverticulitis, gastrointestinal perforation, ulcerative colitis).
  • 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.
  • Known hypersensitivity to OKZ or any other component of the product or placebo.
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
  • Other protocol-defined non-inclusion criteria apply.

Who cannot join

None listed.

Trial locations and contacts

33 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yana Deloveri contact

+ 7 (968) 585-13-49

deloveri@rpharm.ru

Maria Lemak contact

+7 (903) 709-20-43

lemak@rpharm.ru

33 sites in 1 country

Russia33 sites, 33 recruiting

  • Regional Clinical Hospital Regional state budgetary healthcare institution

    Barnaul, 656024

    Recruiting

  • Regional Clinic Hospital№3

    Chelyabinsk, 454001

    Recruiting

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk, 454048

    Recruiting

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

    Gatchina, 188300

    Recruiting

  • LLC" Medsi-Izhevsk"

    Izhevsk, 426011,

    Recruiting

  • LLC "Scientific Research Medical Complex "Your Health"

    Kazan', 420094

    Recruiting

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

    Kemerovo, 650000

    Recruiting

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

    Krasnodar, 350086

    Recruiting

  • City Clinical Hospital named after Davydovsky I.V.

    Moscow, 109240

    Recruiting

  • GBUZ Moscow Clinical Scientific Center named after Loginov MHD

    Moscow, 111123

    Recruiting

  • Scientific Research Institute of Reumatology named after Nasonova V.A

    Moscow, 115522

    Recruiting

  • Moscow City Polyclinic №52

    Moscow, 117546

    Recruiting

  • Clinical Hospital №4 of Sechenov University

    Moscow, 119048

    Recruiting

  • Clinical Hospital №3 of Sechenov University

    Moscow, 119435

    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

    Recruiting

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

    Moscow, 123182

    Recruiting

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

    Moscow, 127473

    Recruiting

  • Moscow Regional Research and Clinical Institute "MONIKI"

    Moscow, 129110

    Recruiting

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

    Novosibirsk, 630117

    Recruiting

  • Republican Hospital named after V.A. Baranov

    Petrozavodsk, 185019

    Recruiting

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

    Saint Petersburg, 139036

    Recruiting

  • LLC"Energy of Health"

    Saint Petersburg, 194156

    Recruiting

  • Medical Center "Interleukin"

    Saint Petersburg, 194214

    Recruiting

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

    Saint Petersburg, 194354

    Recruiting

  • LLC"Kurator"

    Saint Petersburg, 196240,

    Recruiting

  • State Healthcare Institution "Regional Clinical Hospital"

    Saratov, 410053

    Recruiting

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

    Smolensk, 214006

    Recruiting

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

    Tomsk, 634040

    Recruiting

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

    Ufa, 450008

    Recruiting

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

    Vladimir, 600023

    Recruiting

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

    Voronezh, 394066

    Recruiting

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

    Yaroslavl, 150003

    Recruiting

  • Ural research Institute of Phthisiopulmonology

    Yekaterinburg, 620039

    Recruiting

Other trials in Russia

About this study

Official title: 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

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).

Read the detailed description

This is a phase 2/3 study with double-blind parallel-group adaptive design.

The study will include the following periods:

  1. Screening period (4 weeks) Screening period (before the first administration of the test drug). Before being included in the study, patients will be provided with complete information about this clinical trial and signs the Informed consent Form (IF). After that the researcher will decide whether or not the patient can be randomized into the study.
  2. Double-blind Treatment period (48 weeks). Following the completion of a Treatment period, all patients will be enrolled in Follow-up Period (FU).
  3. Follow-up Period (24 weeks). During the FU Period, patients will visit study sites after 4,12 and 24 weeks after the end of the Treatment Period to complete FU-1 (Week 52), FU-2 (Week 60) and FU-3 (Week 72) visits.

The overall study duration for the patients will be approximately 76 weeks (including the 4 weeks screening period)

The analysis will be conducted in two sequential steps:

  • the interim analysis after 61 percent (%) of patients have completed the Treatment period (not including the FU period)
  • the final analysis when all patients have completed all periods (the Treatment and the FU periods).
Being tested
Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL), SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL
Keywords
Progressive Fibrosing Interstitial Lung Diseases, Olokizumab, Forced vital capacity
Medical subject headings
Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Artlegia

    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 mLDrug

    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.

Study groups in NCT06440746
Study groupRoleWhat they receive
Arm1:OKZ 64 mg q4wExperimentalSC injections of OKZ 64 mg q4w
Receives: Drug: Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)
Arm2:PlaceboPlacebo comparatorSC injections of Placebo q4w
Receives: Drug: SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 weeks

Secondary outcomes (13)

  1. Change in FVC from baseline

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

    Measured: 24, 48 weeks.

  2. Change in FVC.% predicted

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

    Measured: 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.

    Measured: 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.

    Measured: 48 weeks

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

    Change in absolute values of DLCO from baseline at treatment weeks 24 and 48.

    Measured: 24,48 weeks

  6. Change in the values of quantitative assessment of lung fibrosis from baseline

    Change in the values of quantitative assessment of lung fibrosis from baseline based on high-resolution computed tomography (HRCT) data at treatment week 48.

    Measured: 48 weeks

  7. Proportion of patients with progression or death

    Proportion of patients with progression or death: the first event defined as death.

    Progression is a decrease in FVC ≥10% predicted, or decrease in DLCO ≥15% predicted from their baseline values.

    Measured: 48 weeks

  8. Time to progression or death assessed over 48 weeks of treatment

    Time to progression or death assessed over 48 weeks of treatment.

    Measured: 48 weeks

  9. Time to exacerbation over 48 weeks of treatment

    An exacerbation of idiopathic lung fibrosis and other ILDs is defined as worsening shortness of breath over the past 30 days combined with evidence of new bilateral lesions appearing as ground-glass opacities and/or consolidations on a chest HRCT scan without other alternative causes (infections and other).

    Measured: 48 weeks

  10. Proportion of patients with exacerbation at treatment weeks 24 and 48

    Proportion of patients with exacerbation over 48 weeks of treatment.

    Measured: 24,48 weeks

  11. Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea scores from baseline at treatment weeks 24 and 48

    FACIT-Dyspnea questionnaire includes Dyspnea subscale, that measures the severity of dyspnea when doing everyday activities, and Functional Limitations subscale that measures the amount of difficulty experienced while doing these activities due to dyspnea in the past 7 days. Both subscales contain 10 items scored from 0 (best) to 4 (worst).

    A raw score (normal-worst range 0-30) is calculated as: Sum individual item scores * 10 / number of items answered. Raw scores are then converted to scale scores using the table included in the FACIT Dyspnoea Scale Short Form Scoring Guideline.

    Scale score range: Dyspnea subscale from 27.7 (normal condition) to 75.9 (severe symptoms); Functional Limitations subscale from 29.7 (not limited) to 76.7 (severely limited)

    Measured: 24,48 weeks

  12. Change in Short Form-36 (SF-36) scores from baseline at treatment weeks 24 and 48

    36-Item Short-Form Health Survey (SF-36) is a patient reported survey of health consisting of 36 items that taps eight health concepts (domains): vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. It also includes a single item that provides an indication of perceived change in health. For each domain a scaled score is calculated as the weighted sum of the questions in this section. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: 24,48 weeks

  13. Change in Modified Medical Research Council ( mMRC) dyspnea score from baseline at treatment weeks 24 and 48

    Modified Medical Research Council (mMRC) Dyspnea Scale is used to assess perceived degree of baseline functional disability due to dyspnea. Participants indicate a score on 5-point scale according to the severity of their symptoms: none = 0; mild = 1; moderate = 2; severe =3; very severe = 4

    Measured: 24,48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start23 Aug 2023
  3. Primary completion9 Apr 2027 (estimated)
  4. Study completion25 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06440746
Sponsor's protocol ID
CL04041109
Status last verified
Nov 2024
First submitted
28 May 2024
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL) in people with Lung Diseases, Interstitial, run by R-Pharm International, LLC at 33 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yana Deloveri (+ 7 (968) 585-13-49, deloveri@rpharm.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of forced vital capacity (FVC) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06440746.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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