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Tests treatment safety and results for Lung Diseases, Interstitial
Official title Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases
ClinicalTrials.gov ID: NCT06440746
What this study is testing
What is Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)?
Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for lung diseases, interstitial.
Also referred to as Artlegia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- To assess this criterion (I), patient's pulmonary function test (PFT) results obtained within 12 months prior to screening must available. If data...
- Patients' results of at least one chest HRCT investigation performed no earlier than 24 months before randomization must be available for review. If...
- stable course of the main disease not requiring a change in maintenance treatment.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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-
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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-apply.
The study team makes the final eligibility decision.
Where it's taking place
- Barnaul, Russia
- Chelyabinsk, Russia
- Gatchina, Russia
- Izhevsk, Russia
- Kazan', Russia
- Kemerovo, Russia
- Krasnodar, Russia
- Moscow, Russia
- Novosibirsk, Russia
- Petrozavodsk, Russia
- Saint Petersburg, Russia
- Saratov, Russia
- Smolensk, Russia
- Tomsk, Russia
- Ufa, Russia
- Vladimir, Russia
- Voronezh, Russia
- Yaroslavl, Russia
- Yekaterinburg, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barnaul, Russia; Chelyabinsk, Russia; Gatchina, Russia; Izhevsk, Russia; Kazan', Russia; Kemerovo, Russia and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.