[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"R-Pharm International, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,80,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100640322","phase-3-study-of-the-efficacy-and-safety-of-goflikicept-and-olokizumab-as-the-second-line-therapy-in-patients-with-stills-disease-100640322",false,"NCT07625384","Study of the Efficacy and Safety of Goflikicept and Olokizumab as the Second-line Therapy in Patients With Still's Disease","International Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study of the Efficacy and Safety of Goflikicept and Olokizumab as the Second-line Therapy in Patients With Still's Disease","Inclusion Criteria:\n\n1. Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study\n2. Confirmed diagnosis of Adult-Onset Still's Disease (AOSD) based on the Yamaguchi M. diagnostic criteria\n3. Patient with active disease or low disease activity per DAVID criteria\n4. In case of current corticosteroid (CS) use, doses must be stable for at least 2 weeks prior to Day 0. The maximum allowed dose of CS is 1 mg\u002Fkg\u002Fday, up to 60 mg\u002Fday (prednisolone equivalent)\n5. In case of current nonsteroidal anti-inflammatory drugs (NSAID) use, dose of NSAIDs must be stable for at least 2 weeks prior to Day 0\n6. In case of current methotrexate (MTX) use, the dose of MTX must be stable for at least 4 weeks prior to Day 0. The maximum allowed dose is 30 mg\u002Fweek. In case of prior MTX discontinuation, it must be performed at least 4 weeks before Day 0\n7. Patient's ability and willingness, in the reasonable opinion of the investigator, to attend the clinical center for all scheduled visits, perform study procedures, and comply with protocol requirements, including consent to receive subcutaneous injections by qualified personnel\n8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant (excluding women who are post-menopausal, defined retrospectively as 12 months of natural amenorrhea with appropriate clinical status, e.g., age-appropriate), must agree to use highly effective methods of contraception throughout the study, starting from the signing of the ICF until at least 8 weeks after the last dose of study treatment; and must have a negative pregnancy test (serum human chorionic gonadotropin, hCG)\n9. Sexually active male participants must agree to use highly effective methods of contraception throughout the study, starting from the signing of the ICF until at least 8 weeks after the last dose of study treatment\n\nExclusion Criteria:\n\n1. Hypersensitivity to the active and\u002For inactive ingredients of the investigational product\n2. Prior use of the following medications:\n\n   * Rilonacept - less than 6 weeks prior to Day 0\n   * Canakinumab - less than 20 weeks prior to Day 0\n   * Anakinra - less than 1 week prior to Day 0\n   * TNF-alpha inhibitors: etanercept less than 2 weeks, adalimumab, certolizumab, or golimumab less than 10 weeks prior to Day 0\n   * IL-6 inhibitors: olokizumab - less than 20 weeks, tocilizumab - less than 16 weeks, or sarilumab less than 8 weeks prior to Day 0\n   * Janus kinase (JAK) inhibitors - less than 1 week prior to Day 0\n   * Immunosuppressants (azathioprine less than 3 days, cyclosporine less than 1 week, mycophenolate mofetil less than 1 week, tacrolimus less than 10 days, mercaptopurine less than 2 days, etc., except for methotrexate) - less than 5 half-lives prior to Day 0\n   * Leflunomide - less than 10 weeks prior to Day 0\n   * Corticosteroid pulse therapy (e.g., intravenous methylprednisolone 250-1000 mg\u002Fday or equivalent dose of dexamethasone for 3 days) - less than 4 weeks (from the completion of pulse therapy) prior to Day 0\n   * Intravenous immunoglobulin (IVIG) - less than 4 weeks prior to Day 0\n   * Other biologic drug with immunosuppressive effects - less than 5 half-lives prior to Day 0\n3. Use of live-attenuated vaccines within less than 3 months prior to Day 0 (start of the treatment period in the study) and\u002For anticipated need for such vaccination within 3 months after completion of the investigational therapy. Live-attenuated vaccines include vaccines against measles, rubella, mumps, varicella, rotavirus, influenza (intranasal), yellow fever, poliomyelitis (oral polio vaccine), as well as vaccines against tuberculosis (BCG), typhoid (oral typhoid vaccine), and epidemic typhus. Immunocompetent household members of the patient must refrain from receiving oral polio vaccine during the patient's participation in the study\n4. Presence of conditions or signs that, in the investigator's opinion, indicate impaired immune response and\u002For significantly increase the risk associated with immunomodulatory therapy, including but not limited to:\n\n   * Active bacterial, fungal, viral, or protozoal infection at the start of the screening period\n   * Opportunistic infections and\u002For Kaposi's sarcoma at the start of screening\n   * Chronic bacterial, fungal, or viral infection requiring systemic parenteral therapy at the start of screening\n   * HIV infection, viral hepatitis B or C, or syphilis (patients with hepatitis B and\u002For C who have received antiviral therapy and have had undetectable viral load for at least 6 months may be eligible, subject to confirmation by an appropriate specialist)\n5. History of active tuberculosis (TB); suspected or confirmed active tuberculosis at present; or signs of active tuberculosis, including chest computed tomography (CT) or chest X-ray findings consistent with pulmonary tuberculosis during screening; or presence of risk factors for tuberculosis, including but not limited to:\n\n   * Living conditions associated with increased risk of exposure (e.g., correctional facilities, homeless shelters) within 1 year prior to randomization\n   * Healthcare workers with unprotected exposure to patients at high risk of TB or with TB within 1 year prior to randomization\n   * Close contact (i.e., prolonged cohabitation for days or weeks, not minutes or hours) with a person with active tuberculosis within 1 year prior to randomization\n6. History of latent TB without adequate treatment, regardless of screening QuantiFERON-TB\u002FT-SPOT.TB results, or a positive QuantiFERON-TB\u002FT-SPOT.TB result at screening. Such patients may be re-screened and enrolled if all of the following are met:\n\n   * Active TB is ruled out by a certified TB specialist\n   * The patient has completed at least 30 days of prophylactic anti-TB therapy for LTBI prior to screening, using country-recommended regimens\n   * The patient agrees to complete the full course of LTBI treatment\n7. Any other significant comorbidities (cardiovascular, neurological, endocrine, renal, gastrointestinal, hepatic, coagulation disorders, other systemic rheumatic diseases, psychiatric disorders, etc.) that, in the investigator's judgment, may adversely affect participation, patient safety, or study results\n8. History of organ transplantation or need for transplantation at screening\n9. Malignancy during screening or within 5 years prior, except adequately treated non-metastatic basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of any type after complete resection\n10. Pregnancy or breastfeeding\n11. Alcohol or substance abuse, in the investigator's opinion\n12. Severe renal impairment: creatinine clearance (Cockcroft-Gault) \\\u003C 30 mL\u002Fmin\n13. Laboratory abnormalities:\n\n    * Absolute neutrophil count \\\u003C 1.5 × 10\\^9\u002FL\n    * Leukocytes \\\u003C 3.5 × 10\\^9\u002FL\n    * Platelets \\\u003C 100 × 10\\^9\u002FL\n    * Hemoglobin ≤ 80 g\u002FL\n    * HbA1c ≥ 8%\n    * ALT and\u002For AST \\> 8 × ULN\n    * AST and\u002For ALT \\> 3 × ULN with bilirubin \\> 1.5 × ULN\n    * Total bilirubin \\> 2 × ULN (except confirmed Gilbert's syndrome)\n14. Participation in another clinical trial at screening or use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to Visit 1 (start of treatment period)\n15. Presence or suspicion of macrophage activation syndrome (MAS) at screening. MAS criteria includes persistent fever, splenomegaly, elevated or rising serum ferritin levels, cytopenia, abnormal liver function tests, intravascular activation of coagulation, and elevated or rising serum triglyceride levels\n16. Diagnosis of MAS within 2 months prior to Day 0\n17. Prior participation in this clinical study, provided the patient received at least one dose of the investigational product","ALL","18 Years",{"count":19,"type":20},52,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The primary objective of the study is to evaluate the efficacy and safety of goflikicept (GFC) and olokizumab (OKZ) in patients with Still's disease",[26],"Still Disease",[28,29,30,31],"Still's Disease","Goflikicept","RPH-104","Olokizumab","NOT_YET_RECRUITING","2026-05-28",{"date":35,"type":36},"2026-06-04","ACTUAL",{"date":38,"type":20},"2026-05-18",{"date":40,"type":20},"2028-07-01",{"name":42,"class":43},"R-Pharm International, LLC","INDUSTRY",25,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100632737","phase-2-pharmacokinetics-efficacy-and-safety-of-olokizumab-in-patients-with-juvenile-idiopathic-arthritis-100632737","NCT07517575","Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis","An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis","Inclusion Criteria:\n\n1. Study informed consent form voluntarily and independently signed by patient legal representative\n2. Study assent form voluntarily and independently signed by minor study subject (patient)\n3. Male or female patients aged ≥12 and \\\u003C18 years (cohort 1 - subgroup A) or \\>2 and \\\u003C12 years (cohort 1 - subgroup B) or \\>2 and \\\u003C18 years (cohort 2) at the time of screening initiation and on Day 0\n4. Body weight at the start of screening and on Day 0 ≥45 kg (cohort 1 - subgroup A) or ≥30 and \\\u003C45 kg (cohort 1 - subgroup B) or ≥18 and \\\u003C30 kg (cohort 2)\n5. A reliable diagnosis of juvenile idiopathic arthritis (JIA) according to the JIA International League of Associations for Rheumatology (ILAR) 1 criteria with onset before the age of 16 years:\n\n   1. Seropositive or seronegative polyarthritis (pJIA) ≥3 months before screening, or\n   2. Systemic JIA (sJIA) for ≥3 months before screening, provided that joint symptoms persist without active systemic manifestations for ≥3 months before screening, or\n   3. Extended oligoarticular JIA (оJIA) ≥3 months before screening\n6. American College of Radiology (ACR) criteria of active polyarthritis are met: 5 or more active joints at screening and on Day 0\n7. C-reactive protein (CRP) level on screening or in anamnesis, not associated with alternative causes of increase other than the activity of the underlying disease, ≥6 mg\u002Fl\n8. Intolerance or failure of methotrexate in the dose of ≥15 mg\u002Fm\\^2\u002Fweek (or less, in a case of documented intolerance of higher doses) for ≥3 months in medical history\n\nExclusion Criteria:\n\n1. Prior use of any drug that acts directly on IL-6 or IL-6R\n2. If methotrexate is administered - any change in dose or in a formulation within 6 weeks prior to Day 0\n3. Previous therapy with marketed or experimental conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying anti-rheumatic drugs (bDMARDs) within less than 5 elimination half-lives\n4. Use of oral steroids in the doses above 0.2 mg\u002Fkg or 10 mg\u002Fday of prednisolone daily, whatever is lower, or a change in dose within 2 weeks prior to Day 0, or use of parenteral or topical steroids within 4 weeks prior to Day 0\n5. Change in dose of a non-steroidal anti-inflammatory drug (NSAID) within ≤2 weeks prior to Day 0\n6. Vaccination with live vaccines within 6 weeks before baseline, or planned vaccination with live vaccines during the study and\u002For within 6 weeks after the last olokizumab administration\n7. Active uveitis at screening or uveitis exacerbation within 24 weeks before screening\n8. Laboratory abnormalities (creatinine ≥1 mg\u002FdL (88 mM) for children aged 12 or ≥1.2 mg\u002FdL (106 mM) for children aged 13 and older; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 х upper limit normal (ULN); platelets \\\u003C180,000\u002Fmm\\^3; white blood count (WBC) \\\u003C4000\u002Fmm\\^3; neutrophils \\\u003C2000\u002Fmm\\^3; hemoglobin ≤80 g\u002FL\n9. Exclusion criteria related to past or current infection other than tuberculosis\n10. Suspected or confirmed current tuberculosis (TB) infection, history of an active or latent TB infection\n11. Active course of a disease associated with formation of intestinal diverticula, or any other symptomatic gastrointestinal disease that may increase risk of perforation; or a history of diverticulitis or perforation; or concurrent Crohn's disease or ulcerative colitis\n12. Concurrent heart failure New York Heart Association (NYHA) III or IV functional class\n13. In patients with diabetes mellitus - HbA1c \\> 7% within the last 3 months (non-controlled diabetes mellitus)\n14. Patients with Steinbrocker class IV functional impairment\n15. Presence of systemic autoimmune or autoinflammatory disease, except JIA, or chronic autoimmune hepatitis or diseases of the primary immunodeficiencies group\n16. Patients with history of macrophage activation syndrome episodes\n17. Exclusion criteria related to concurrent diseases and conditions that may increase potential risk related to participation in the study and study drug exposure\n18. Known hypersensitivity to any component of the study drug\n19. Pregnant or breast-feeding female participants or planned pregnancy\n20. Other protocol-defined non-inclusion criteria apply","2 Years","17 Years",{"count":55,"type":20},71,[57],"PHASE2","The primary objective of this study is to evaluate the pharmacokinetics (PK) of olokizumab (OKZ) in patients with polyarticular juvenile idiopathic arthritis aged \\>2 and \\\u003C18 years in two doses (64 mg or 48 mg every 4 weeks) depending on patient's weight. Secondary objectives are to evaluate the pharmacodynamic (PD) profile, the long-term efficacy and safety of olokizumab in patients with polyarticular juvenile idiopathic arthritis aged \\>2 and \\\u003C18 years.",[60],"Juvenile Idiopathic Arthritis",[62,63,64,65,66,67,68,69],"olokizumab","interleukin-6 (IL-6)","C-reactive protein (CRP)","Musculoskeletal Diseases","Autoimmune Diseases","Rheumatic Diseases Connective Tissue Diseases","Arthritis","Juvenile Arthritis","RECRUITING","2026-04-01",{"date":73,"type":36},"2026-04-08",{"date":75,"type":36},"2023-03-17",{"date":77,"type":20},"2030-06",{"name":42,"class":43},14,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100453934","phase-2-safety-and-efficacy-of-rph-104-used-to-prevent-recurrent-fever-attacks-in-adult-patients-with-colchicine-resistant-or-colchicine-intolerant-familial-mediterranean-fever-100453934","NCT05190991","Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever","An International Multicenter Open-label Clinical Study of the Safety and Efficacy of RPH-104 for Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine","Inclusion Criteria:\n\n1. The patient with Familial Mediterranean Fever (FMF) with resistance to or intolerance of colchicine, who completed the core study, during which he\u002Fshe received at least one dose of RPH-104.\n2. Voluntarily signed and dated Patient Informed Consent Form (ICF) for participation in this study.\n3. The patient's ability and desire, according to the Investigator's discretion, to follow the schedule of visits, follow the study procedures and follow the Protocol requirements, including the following:\n\n   * to visit the study site every 2 weeks for RPH-104 administration by qualified study site personnel\n\nor\n\n• to learn the subcutaneous (SC) injection technique and self-administer RPH-104 at his\u002Fher accommodation as per the study Protocol\n\nor\n\n• to agree with the qualified medical personnel visits to his\u002Fher accommodation for RPH-104 administration.\n\nExclusion Criteria:\n\n1. Any medically significant event that was observed in a patient during his\u002Fher participation in the core study, as well as any other medical conditions (including psychiatric disorders) or laboratory abnormalities, which may increase the potential risk associated with participation in the study and treatment with RPH-104, or may affect the interpretation of the study results, and which, according to the Investigator's opinion, may lead to the patient's non-compliance with the study inclusion criteria.\n2. Pregnant and\u002For lactating women or women planning pregnancy during the study or within 2 months after the last RPH-104 dose.\n3. Women of childbearing potential, i.e. all females with physiological ability to conceive except for those with final cessation of menses, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status, for example, at respective age, who do not agree to use highly effective contraceptives throughout the study, starting from the moment of signing the ICF and for at least 8 weeks after the last RPH-104 dose or Men who are sexually active and do not agree to use highly effective contraceptives throughout the study, starting from the moment of signing the ICF and for at least 8 weeks after the last RPH-104 dose.\n\n   Highly effective contraception methods include:\n   * complete abstinence: if it corresponds to the preferred and conventional lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation method) and interrupted coitus are not considered acceptable contraceptive methods;\n   * female sterilization: surgical bilateral ovariectomy (with\u002Fwithout hysterectomy) or tubal ligation at least 6 weeks before the start of the core study. In a case of ovariectomy only, the female reproductive status should be verified by further hormonal test;\n   * male sterilization (with documented absence of sperm in ejaculate post vasectomy) at least 6 months before the start of the core study. Vasectomized male partner should be the only partner of the participating female subject;\n   * combination of any two of the following methods (a+b or a+c or b+c):\n\n     1. use of oral, injectable or implanted hormonal contraceptives; in a case of oral contraceptives, the woman should constantly use the same product as was used during the core study;\n     2. installation of an intrauterine device or contraceptive system;\n     3. use of barrier contraceptives: condom or occlusive cap (diaphragm or cervical cap\u002Fcontraceptive vaginal ring) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository\n4. The need for a therapy with any of the following products from the moment of signing the ICF till the study treatment period completion:\n\n   * systemic glucocorticoids at a dose exceeding 0,2 mg\u002Fkg\u002Fday of prednisolone (or 0,16 mg\u002Fkg\u002Fday of methylprednisolone, or an equivalent dose of another glucocorticoid) orally;\n   * rilonacept, tocilizumab, rituximab, canakinumab, tumor necrosis factor alpha (TNF-a) inhibitors (TNFi) and other biological products (except for RPH-104);\n   * immunosuppressants (cyclosporine, methotrexate, leflunomide, thalidomide, azathioprine, 6-mercaptopurine, cyclophosphamide, etc.);\n   * methylprednisolone (or an equivalent) at a dose of more than 40 mg\u002Fday parenterally;\n   * intramuscular, intra-articular or peri-articular administration of glucocorticoids;\n   * anakinra;\n   * tofacitinib, baricitinib;\n   * any experimental drugs (except for RPH-104)\n5. The need to use a live (attenuated) vaccine during the study or within 3 months after the last RPH-104 dose. Live attenuated vaccines include vaccines against viruses: measles, rubella, mumps, chickenpox, rotavirus, flu (as a nasal spray), yellow fever, polio (oral polio vaccine); vaccines against tuberculosis (BCG), typhoid fever (oral typhoid vaccine) and typhus (typhus vaccine). Immunocompetent family members of the patient should not be vaccinated with the oral polio vaccine during the patient's participation in the study\n6. Positive results of tuberculosis screening performed at Visit 10 of the core study (QuantiFERON-Tuberculosis(TB)\u002FT-Spot.TB test, chest X-ray).\n7. Participation in other experimental studies (except for the core study).","80 Years",{"count":89,"type":20},60,[57],"The purpose of this study is to assess safety and efficacy of the long-term treatment with RPH-104 at doses of 80 or 160 mg once every 2 weeks (q2w) in patients with familial Mediterranean fever (FMF) with colchicine resistance or intolerance (i.e. colchicine resistant, crFMF), who completed the core study, during which they received at least one dose of RPH-104 (i.e. study patient population).",[93,94],"Familial Mediterranean Fever","FMF",[30,96,97,98,99,94,100],"colchicine inefficacy","colchicine intolerance","colchicine resistance","subcutaneous","interleukin-1 inhibitor","2024-12-10",{"date":103,"type":36},"2024-12-16",{"date":105,"type":36},"2021-10-05",{"date":107,"type":20},"2029-01",{"name":42,"class":43},8,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100549952","phase-2-efficacy-and-safety-of-olokizumab-in-patients-with-progressive-fibrosing-interstitial-lung-diseases-100549952","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.",{"count":118,"type":20},138,[57,23],"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).",[122],"Lung Diseases, Interstitial",[124,31,125],"Progressive Fibrosing Interstitial Lung Diseases","Forced vital capacity","2024-11-15",{"date":128,"type":36},"2024-11-19",{"date":130,"type":36},"2023-08-23",{"date":132,"type":20},"2028-12-25",{"name":42,"class":43},33,""]