[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549952":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":306,"collaborators":308,"id":316,"slug":317,"hasResults":318,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":32,"eligibilityCriteria":322,"healthyVolunteers":318,"sex":323,"minAge":324,"maxAge":32,"enrollmentInfo":325,"targetDuration":32,"studyType":328,"phases":329,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},{"fullName":5,"class":6},"R-Pharm","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm1:OKZ 64 mg q4w","EXPERIMENTAL","SC injections of OKZ 64 mg q4w",[13],"Drug: Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm2:Placebo","PLACEBO_COMPARATOR","SC injections of Placebo q4w",[19],"Drug: SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL)","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)\u002FmL.",[9],[27],"Artlegia",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL","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.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Mikhail Samsonov","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Yana Deloveri","CONTACT","+ 7 (968) 585-13-49","deloveri@rpharm.ru",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Maria Lemak","+7 (903) 709-20-43","lemak@rpharm.ru",[48,61,70,76,85,94,103,112,121,130,136,142,148,154,160,166,171,177,183,192,201,210,216,222,228,234,243,252,261,270,279,288,297],{"facility":49,"status":50,"city":51,"state":32,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":32},"Regional Clinical Hospital Regional state budgetary healthcare institution","RECRUITING","Barnaul","656024","Russia","RU",{"type":56,"coordinates":57},"Point",[58,59],83.72786,53.36199,{"lat":59,"lon":58},{"facility":62,"status":50,"city":63,"state":32,"zip":64,"country":53,"countryCode":54,"cosmosGeoPoint":65,"geoPoint":69,"contacts":32},"Regional Clinic Hospital№3","Chelyabinsk","454001",{"type":56,"coordinates":66},[67,68],61.42877,55.1611,{"lat":68,"lon":67},{"facility":71,"status":50,"city":63,"state":32,"zip":72,"country":53,"countryCode":54,"cosmosGeoPoint":73,"geoPoint":75,"contacts":32},"Chelyabinsk Regional Clinical Hospital","454048",{"type":56,"coordinates":74},[67,68],{"lat":68,"lon":67},{"facility":77,"status":50,"city":78,"state":32,"zip":79,"country":53,"countryCode":54,"cosmosGeoPoint":80,"geoPoint":84,"contacts":32},"State budgetary healthcare institution of the Leningrad region \"Gatchina Clinical Interdistrict Hospital\"","Gatchina","188300",{"type":56,"coordinates":81},[82,83],30.12833,59.57639,{"lat":83,"lon":82},{"facility":86,"status":50,"city":87,"state":32,"zip":88,"country":53,"countryCode":54,"cosmosGeoPoint":89,"geoPoint":93,"contacts":32},"LLC\" Medsi-Izhevsk\"","Izhevsk","426011,",{"type":56,"coordinates":90},[91,92],53.19862,56.85225,{"lat":92,"lon":91},{"facility":95,"status":50,"city":96,"state":32,"zip":97,"country":53,"countryCode":54,"cosmosGeoPoint":98,"geoPoint":102,"contacts":32},"LLC \"Scientific Research Medical Complex \"Your Health\"","Kazan'","420094",{"type":56,"coordinates":99},[100,101],49.12214,55.78874,{"lat":101,"lon":100},{"facility":104,"status":50,"city":105,"state":32,"zip":106,"country":53,"countryCode":54,"cosmosGeoPoint":107,"geoPoint":111,"contacts":32},"Kuzbass Clinical Hospital Emergency Medical Care named after Podgorbunsky M.A","Kemerovo","650000",{"type":56,"coordinates":108},[109,110],86.10435,55.35417,{"lat":110,"lon":109},{"facility":113,"status":50,"city":114,"state":32,"zip":115,"country":53,"countryCode":54,"cosmosGeoPoint":116,"geoPoint":120,"contacts":32},"State Budgetary Healthcare Institution Research Institute-Karpaty Clinical Hospital No. 1 named after prof. S.V. Ochapovsky","Krasnodar","350086",{"type":56,"coordinates":117},[118,119],38.98178,45.04534,{"lat":119,"lon":118},{"facility":122,"status":50,"city":123,"state":32,"zip":124,"country":53,"countryCode":54,"cosmosGeoPoint":125,"geoPoint":129,"contacts":32},"City Clinical Hospital named after Davydovsky I.V.","Moscow","109240",{"type":56,"coordinates":126},[127,128],37.61781,55.75204,{"lat":128,"lon":127},{"facility":131,"status":50,"city":123,"state":32,"zip":132,"country":53,"countryCode":54,"cosmosGeoPoint":133,"geoPoint":135,"contacts":32},"GBUZ Moscow Clinical Scientific Center named after Loginov MHD","111123",{"type":56,"coordinates":134},[127,128],{"lat":128,"lon":127},{"facility":137,"status":50,"city":123,"state":32,"zip":138,"country":53,"countryCode":54,"cosmosGeoPoint":139,"geoPoint":141,"contacts":32},"Scientific Research Institute of Reumatology named after Nasonova V.A","115522",{"type":56,"coordinates":140},[127,128],{"lat":128,"lon":127},{"facility":143,"status":50,"city":123,"state":32,"zip":144,"country":53,"countryCode":54,"cosmosGeoPoint":145,"geoPoint":147,"contacts":32},"Moscow City Polyclinic №52","117546",{"type":56,"coordinates":146},[127,128],{"lat":128,"lon":127},{"facility":149,"status":50,"city":123,"state":32,"zip":150,"country":53,"countryCode":54,"cosmosGeoPoint":151,"geoPoint":153,"contacts":32},"Clinical Hospital №4 of Sechenov University","119048",{"type":56,"coordinates":152},[127,128],{"lat":128,"lon":127},{"facility":155,"status":50,"city":123,"state":32,"zip":156,"country":53,"countryCode":54,"cosmosGeoPoint":157,"geoPoint":159,"contacts":32},"Clinical Hospital №3 of Sechenov University","119435",{"type":56,"coordinates":158},[127,128],{"lat":128,"lon":127},{"facility":161,"status":50,"city":123,"state":32,"zip":162,"country":53,"countryCode":54,"cosmosGeoPoint":163,"geoPoint":165,"contacts":32},"State Budgetary Healthcare Institution of Moscow City \"City Clinical Hospital №52\" of the Moscow City Health Department\", Consultative and diagnostic department №2","123182",{"type":56,"coordinates":164},[127,128],{"lat":128,"lon":127},{"facility":167,"status":50,"city":123,"state":32,"zip":162,"country":53,"countryCode":54,"cosmosGeoPoint":168,"geoPoint":170,"contacts":32},"State Budgetary Healthcare Institution of Moscow City \"City Clinical Hospital №52\" of the Moscow City Health Department\"",{"type":56,"coordinates":169},[127,128],{"lat":128,"lon":127},{"facility":172,"status":50,"city":123,"state":32,"zip":173,"country":53,"countryCode":54,"cosmosGeoPoint":174,"geoPoint":176,"contacts":32},"FSBEI HE \"Russian University of Medicine\", MoH of Russia","127473",{"type":56,"coordinates":175},[127,128],{"lat":128,"lon":127},{"facility":178,"status":50,"city":123,"state":32,"zip":179,"country":53,"countryCode":54,"cosmosGeoPoint":180,"geoPoint":182,"contacts":32},"Moscow Regional Research and Clinical Institute \"MONIKI\"","129110",{"type":56,"coordinates":181},[127,128],{"lat":128,"lon":127},{"facility":184,"status":50,"city":185,"state":32,"zip":186,"country":53,"countryCode":54,"cosmosGeoPoint":187,"geoPoint":191,"contacts":32},"Federal Research Center Institute of Cytologyand Genetics,Siberian Branch of Russian Academy of Sciences","Novosibirsk","630117",{"type":56,"coordinates":188},[189,190],82.93175,55.02259,{"lat":190,"lon":189},{"facility":193,"status":50,"city":194,"state":32,"zip":195,"country":53,"countryCode":54,"cosmosGeoPoint":196,"geoPoint":200,"contacts":32},"Republican Hospital named after V.A. Baranov","Petrozavodsk","185019",{"type":56,"coordinates":197},[198,199],34.34691,61.78491,{"lat":199,"lon":198},{"facility":202,"status":50,"city":203,"state":32,"zip":204,"country":53,"countryCode":54,"cosmosGeoPoint":205,"geoPoint":209,"contacts":32},"Saint-Petersburg State Research Institute of Phthisiopulmonology of the Ministry of Healthcare of the Russian Federation","Saint Petersburg","139036",{"type":56,"coordinates":206},[207,208],30.31413,59.93863,{"lat":208,"lon":207},{"facility":211,"status":50,"city":203,"state":32,"zip":212,"country":53,"countryCode":54,"cosmosGeoPoint":213,"geoPoint":215,"contacts":32},"LLC\"Energy of Health\"","194156",{"type":56,"coordinates":214},[207,208],{"lat":208,"lon":207},{"facility":217,"status":50,"city":203,"state":32,"zip":218,"country":53,"countryCode":54,"cosmosGeoPoint":219,"geoPoint":221,"contacts":32},"Medical Center \"Interleukin\"","194214",{"type":56,"coordinates":220},[207,208],{"lat":208,"lon":207},{"facility":223,"status":50,"city":203,"state":32,"zip":224,"country":53,"countryCode":54,"cosmosGeoPoint":225,"geoPoint":227,"contacts":32},"City Multidisciplinary Hospital №2-Expert Center in the field of Pulmonology","194354",{"type":56,"coordinates":226},[207,208],{"lat":208,"lon":207},{"facility":229,"status":50,"city":203,"state":32,"zip":230,"country":53,"countryCode":54,"cosmosGeoPoint":231,"geoPoint":233,"contacts":32},"LLC\"Kurator\"","196240,",{"type":56,"coordinates":232},[207,208],{"lat":208,"lon":207},{"facility":235,"status":50,"city":236,"state":32,"zip":237,"country":53,"countryCode":54,"cosmosGeoPoint":238,"geoPoint":242,"contacts":32},"State Healthcare Institution \"Regional Clinical Hospital\"","Saratov","410053",{"type":56,"coordinates":239},[240,241],45.9901,51.54048,{"lat":241,"lon":240},{"facility":244,"status":50,"city":245,"state":32,"zip":246,"country":53,"countryCode":54,"cosmosGeoPoint":247,"geoPoint":251,"contacts":32},"Regional state budgetary healthcare institution \"Clinical Hospital No. 1\"","Smolensk","214006",{"type":56,"coordinates":248},[249,250],32.05088,54.77826,{"lat":250,"lon":249},{"facility":253,"status":50,"city":254,"state":32,"zip":255,"country":53,"countryCode":54,"cosmosGeoPoint":256,"geoPoint":260,"contacts":32},"Regional State Budgetary Healthcare Institution \"Medical and Sanitary Unit No. 2","Tomsk","634040",{"type":56,"coordinates":257},[258,259],84.98216,56.50049,{"lat":259,"lon":258},{"facility":262,"status":50,"city":263,"state":32,"zip":264,"country":53,"countryCode":54,"cosmosGeoPoint":265,"geoPoint":269,"contacts":32},"Federal State Budgetary Educational Institution of Higher Education \"Bashkir State Medical University\" of the Ministry of Health of the Russian Federation","Ufa","450008",{"type":56,"coordinates":266},[267,268],55.96779,54.74306,{"lat":268,"lon":267},{"facility":271,"status":50,"city":272,"state":32,"zip":273,"country":53,"countryCode":54,"cosmosGeoPoint":274,"geoPoint":278,"contacts":32},"State Budgetary Healthcare Institution of the Vladimir Region \"Regional Clinical Hospital\"","Vladimir","600023",{"type":56,"coordinates":275},[276,277],40.39976,56.13854,{"lat":277,"lon":276},{"facility":280,"status":50,"city":281,"state":32,"zip":282,"country":53,"countryCode":54,"cosmosGeoPoint":283,"geoPoint":287,"contacts":32},"Budgetary healthcare institution of the Voronezh region \"Voronezh Regional Clinical Hospital No1\"","Voronezh","394066",{"type":56,"coordinates":284},[285,286],39.19204,51.66833,{"lat":286,"lon":285},{"facility":289,"status":50,"city":290,"state":32,"zip":291,"country":53,"countryCode":54,"cosmosGeoPoint":292,"geoPoint":296,"contacts":32},"Clinical Hospital of Emergency Medical Care named after Solovyov N.V","Yaroslavl","150003",{"type":56,"coordinates":293},[294,295],39.87368,57.62987,{"lat":295,"lon":294},{"facility":298,"status":50,"city":299,"state":32,"zip":300,"country":53,"countryCode":54,"cosmosGeoPoint":301,"geoPoint":305,"contacts":32},"Ural research Institute of Phthisiopulmonology","Yekaterinburg","620039",{"type":56,"coordinates":302},[303,304],60.61529,56.85733,{"lat":304,"lon":303},{"type":307,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[309,310,312,314],{"name":5,"class":6},{"name":311,"class":6},"Exacte Labs LLC",{"name":313,"class":6},"Data Management 365",{"name":315,"class":6},"Keystat, LLC","100549952","phase-2-efficacy-and-safety-of-olokizumab-in-patients-with-progressive-fibrosing-interstitial-lung-diseases-100549952",false,"NCT06440746","Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases","A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase 2\u002F3 Study of Efficacy and Safety of Olokizumab in Subjects With Progressive Fibrosing Interstitial Lung Diseases","Inclusion Criteria:\n\n1. The patient has signed the Informed Consent Form\n2. Progressive fibrosing ILD confirmed by high-resolution computed tomography (HRCT) documented evidence of \\>10% lung tissue affected at Screening:\n\n   A. Patients with an usual interstitial pneumonia (UIP) -like radiological pattern described in the 2022 American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Association guidelines for the management Idiopathic pulmonary fibrosis (IPF) that do not have an identified primary condition\n\n   В. Patients with progressive interstitial pneumonia with autoimmune features (IPAF) as defined in the American Thoracic Society\u002FEuropean Respiratory Society Statement, 2015\n\n   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.\n\n   Disease progression will be established based on a combination of criterion (I)(a) and criterion (II) or criterion (III)(b)\n\n   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.\n\n   II. Worsening respiratory symptoms without an alternative explanation within 12 months prior to screening.\n\n   III. Increased area affected with fibrosis on chest HRCT (b) (according to the 2022 American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Association guidelines) within 24 months prior to screening.\n   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.\n   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.\n   3. stable course of the main disease not requiring a change in maintenance treatment.\n3. ILD duration of no more than 8 years from the onset of respiratory symptoms by the date screening begins.\n4. Elevated acute phase reactants at screening not related to other causes:\n\n   C-reactive protein level ≥6 mg\u002Fl or Erythrocyte Sedimentation Rate (ESR) ≥28 millimeters per hour (mm\u002Fhour).\n5. FVC ≥ 45% and ≤ 80% predicted at screening.\n\nNon-Inclusion Criteria:\n\n1. Hemoglobin-corrected DLCO \\\u003C 30% predicted at screening.\n2. Significant airway obstruction at screening defined as a Forced expiratory volume in 1 second (FEV1) \u002F FVC ratio of \\\u003C70 %.\n3. 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.\n4. Administration of rituximab within less than 12 months prior to screening.\n5. Treatment with systemic glucocorticosteroids (GCS) at \\>10 mg\u002Fday calculated for prednisolone; or a change in the dose of GCS within 4 weeks before\u002Fduring the screening period; or planned dose changes during the trial.\n6. A history of bone marrow transplantation, total lymphoid tissue irradiation, or administration of ablative ultra-high doses of cyclophosphamide.\n7. Initiation of mycophenolate mofetil or antifibrotic agents (for patients receiving mycophenolate mofetil and\u002For antifibrotics at study entry) less than 12 months prior to screening.\n\n   • If a patient has been taking antifibrotic drugs for \\\u003C12 months and ≥6 months, and the spirometry\u002FDiffusion 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\n8. Discontinuation of previously prescribed antifibrotic agents within 6 months prior to screening (for patients not receiving antifibrotic drugs at study entry).\n9. 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.\n10. Laboratory abnormalities as follows:\n\n    * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase(AST) ≥ 1.5×Upper Limit Normal (ULN)\n    * Platelet count \\\u003C100×10\\^9\u002Flitre (l) (\\\u003C100000\u002Fcubic millimetre (mm\\^3)\n    * Leukocyte count \\\u003C3.5×10\\^9\u002Fl\n    * Absolute neutrophil count \\\u003C2000×10\\^6\u002Fl (\\\u003C2000\u002Fmm\\^3).\n11. Concurrent malignancy or a history of malignancy within the last 5 years.\n12. 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.\n13. 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.\n14. 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.\n15. Patients with diverticulitis or other symptomatic gastrointestinal diseases that may lead to perforation, including such history (for example, diverticulitis, gastrointestinal perforation, ulcerative colitis).\n16. 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.\n17. Known hypersensitivity to OKZ or any other component of the product or placebo.\n18. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.\n19. Other protocol-defined non-inclusion criteria apply.","ALL","18 Years",{"count":326,"type":327},138,"ESTIMATED","INTERVENTIONAL",[330,331],"PHASE2","PHASE3","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).",[334],"Lung Diseases, Interstitial",[336,337,338],"Progressive Fibrosing Interstitial Lung Diseases","Olokizumab","Forced vital capacity","2024-11-15",{"date":341,"type":342},"2024-11-19","ACTUAL",{"date":344,"type":342},"2023-08-23",{"date":346,"type":327},"2028-12-25",{"name":348,"class":6},"R-Pharm International, LLC",33]