[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648803":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":42,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":42,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":91,"whyStopped":42,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inebilizumab (Uplizna®)","ACTIVE_COMPARATOR","Tested IMP: Inebilizumab (Uplizna®), an anti-CD19 monoclonal antibody. Authorization status: Not authorized for the targeted indication; inebilizumab is authorized for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are AQP4-IgG seropositive. Inebilizumab used in this trial is a commercially available medicinal product manufactured by Amgen Europe B.V., with marketing authorization number EU\u002F1\u002F21\u002F1602\u002F001. Administration: The treatment period comprises three intravenous administrations of 300 mg inebilizumab: on Day 1, Day 15, and after 6 months, followed by a 3-months follow-up period. Each infusion will be preceded by methylprednisolone 125 mg and dimetindene maleate 4 mg administered intravenously in 100 ml of 0.9% sodium chloride solution, and paracetamol 500 mg administered orally, to reduce the risk of infusion-related reactions (premedication). The dosing regimen follows the authorized regimen for AQP4-IgG-seropositive NMOSD.",[13],"Drug: Inebilizumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Comparator IMP: Saline solution (0.9% sodium chloride solution) for intravenous infusion. Authorization status: Saline solution is routinely used in clinical practice; it is used as a placebo comparator in this trial and has no expected therapeutic effect on PAIS or ME\u002FCFS. Administration: The treatment period comprises three intravenous placebo administrations: on Day 1, Day 15, and after 6 months, followed by a 3-month follow-up period. To maintain blinding, each placebo infusion is preceded by the same premedication as the inebilizumab infusion: methylprednisolone 125 mg and dimetindene maleate 4 mg administered intravenously in 100 ml of 0.9% sodium chloride solution, and paracetamol 500 mg administered orally.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Inebilizumab","The treatment period comprises three intravenous administrations of 300 mg inebilizumab: on Day 1, Day 15, and after 6 months, followed by a 3-months follow-up period. Each infusion will be preceded by a premediaction (methylprednisolone 125 mg, dimetindene maleate 4 mg, and paracetamol 500 mg) to reduce the risk of infusion-related reactions.",[9],[27],"Anti-CD19 monoclonal antibody",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"The treatment period comprises three intravenous placebo administrations: on Day 1, Day 15, and after 6 months, followed by a 3-month follow-up period. To maintain blinding, each placebo infusion is preceded by the same premedication (methylprednisolone 125 mg, dimetindene maleate 4 mg, and paracetamol 500 mg) as the inebilizumab infusion.",[15],[32],"Saline solution (0.9% sodium chloride solution)",[34],{"name":35,"affiliation":36,"role":37},"Judith Bellmann-Strobl, MD","Charité - Universitätsmedizin Berlin, Berlin, Germany 10117","PRINCIPAL_INVESTIGATOR",[39],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+49 30 450 540258",null,"judith.bellmann-strobl@charite.de",[45],{"facility":46,"status":42,"city":47,"state":42,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Charité - Universitätsmedizin Berlin","Berlin","10117","Germany","DE",{"type":52,"coordinates":53},"Point",[54,55],13.41053,52.52437,{"lat":55,"lon":54},[58,60],{"name":35,"role":40,"phone":59,"phoneExt":42,"email":43},"+49 30 450 540660",{"name":35,"role":37,"phone":42,"phoneExt":42,"email":42},{"type":37,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Judith Bellmann-Strobl","Senior physician","100648803","phase-2-cd19-b-cell-depletion-in-pais-mecfs-patients-100648803",false,"NCT07724834","CD19-B Cell Depletion in PAIS-ME\u002FCFS Patients","Prospective, Randomized, Double-blind, Placebo-controlled Phase 2b Trial Evaluating the Efficacy and Safety of the Anti-CD19 Monoclonal Antibody Inebilizumab Compared With Placebo in Patients With Post-acute Infection Syndromes Fulfilling ME\u002FCFS Criteria (PIONEER)","PIONEER_PAIS","Inclusion Criteria:\n\n* Male\u002Ffemale\u002Fdiverse adults who are 18-65 years old at time of enrollment\n* Subject is able and willing to give informed consent\n* Signed informed consent prior to initiation of any trial related measure\n* Diagnosis of PAIS as defined by WHO for PCS, wi th other infectious triggers\n* Diagnosis of ME\u002FCFS according to CCC criteria with PEM \\> 14 hours = PAIS\u002FCFS\n* Detection of autoantibodies (elevated ß2R adrenergic AAB) prior to immunoadsorption or prior to inclusion to PIONEER\n* Pre-treatment with immunoadsorption in the immunoadsorption studies at least 6 months before study inclusion\n* Documented clinical response to immunoadsorption (minimum increase in SF-36 PF of 10 points at week 8) followed by consecutive worsening of symptoms (minimum decrease in SF-36 PF of 10 points for at least 3 months)\n* Evidence of activated pro inflammatory immune cell status\n* Bell score at screening visit: 30-60\n* Normal thyroid function or sufficiently medicated dysfunction\n* For women of childbearing potential (WOCBP):\n\n  1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or\n  2. If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before randomization, and practicing a highly effective birth control method (failure rate of less than 1%)\n\nExclusion Criteria:\n\n* Contraindication against IMP or AMP\n* Hypersensitivity to the active substance or any of the other ingredients\n* Vaccination less or up to 4 weeks before first visit\n* Immunomodulative therapy \\\u003C 3 month before screening visit\n* Concomitant and previous use of IMP\n* Known SARS-CoV-2 or other infection related organ damage\u002Fcomorbidity\n* Pre-infection history of chronic fatigue syndrome or other fatigue syndromes that are due to associated diseases (e.g., cancer, autoimmune diseases \\[patients with a preexcisting Hashimoto thyroiditis and\u002For fibromyalgia without fatigue syndromes can be included\\])\n* Serious infections, including active or latent and chronic infections such as tuberculosis, HIV, Lues, hepatitis B and C\n* Immune- and immunoglobulin-deficiency or severely immunocompromised condition\n* Any other severe or unstable medical conditions (immune, cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, systemic) or any other condition deemed by the Investigator to pose unacceptable risk, interfere with IP evaluation, or confound study results.\n* At screening : aspartate transaminase (AST) \\> 2.5 × upper limit of normal (ULN), alanine transaminase (ALT) \\> 2.5 × ULN, total bilirubin \\> 1.5 × ULN (unless due to Gilbert's syndrome), platelet count \\\u003C 75,000\u002FµL, hemoglobin \\\u003C 8 g\u002FdL, eGFR\\\u003C30 mL\u002Fmin\u002F1.73 m², total immunoglobulin \\\u003C 900 mg\u002FdL, absolute neutrophil count \\\u003C 1200 cells\u002FµL, CD4 T lymphocyte count \\\u003C 300 cells\u002FµL\n* Concomitant diseases or health constellations causing general physical weakness or fatigue, like: i) renal insufficiency with eGR\\\u003C 15 or diyalsis, ii) impaired liver function with elevated liver enzymes a) Aspartate aminotransferase (AST) and b) Alanin-Aminotransferase (ALT), both \\>35 U\u002Fl for women or \\> 50 U\u002Fl for men, iii) anemia with low hemoglobin-concentrations \\\u003C13,0 g\u002FdL for males and \\\u003C12,0 g\u002FdL for females, and iv) adipositas grades II or higher (BMI: ≥ 35 kg\u002Fm 2) at screening\n* Subject is pregnant or breastfeeding\n* Subject is institutionalized by order of court or public authority\n* Subject who might be dependent on the sponsor, the investigator, or the trial site\n* Participation in another clinical trial with a medical device or an investigational medicinal product within 3 Months or 5 half-lives (whichever is longer) before screening visit","ALL","18 Years","65 Years",{"count":76,"type":77},38,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","Post-acute infection syndromes (PAIS) are long-lasting health problems that can develop after an infection. They include post-COVID-19 syndrome and similar illnesses following other infections. Some people with PAIS develop myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS), a serious and disabling illness that can greatly limit everyday activities. People with ME\u002FCFS may experience severe fatigue, reduced physical and mental function, pain, sleep problems, and problems with the regulation of heart rate and blood pressure. A key feature is post-exertional malaise (PEM), in which symptoms become worse after physical or mental activity. The biological causes of PAIS and ME\u002FCFS are not fully understood, and there is currently no established treatment that targets the underlying disease process.\n\nResearch suggests that changes in the immune system may contribute to PAIS and ME\u002FCFS in some patients. In particular, B cells (a type of immune cell) and autoantibodies (antibodies that react with the body's own structures) may play a role. Previous studies of immunoadsorption, a procedure that removes antibodies from the blood, have shown improvements in some patients with ME\u002FCFS. These findings support further investigation of treatments that target B cells in selected patients.\n\nThe PIONEER\\_PAIS study will investigate whether inebilizumab can improve physical function in adults with PAIS who meet the diagnostic criteria for ME\u002FCFS. The study includes a selected group of patients with evidence of autoantibodies and immune activation who previously improved after immunoadsorption but later experienced worsening of their symptoms. Inebilizumab is a monoclonal antibody that targets CD19, a protein found on B cells, and leads to the depletion of these cells.\n\nParticipants will be randomly assigned to receive either inebilizumab or placebo (saline solution) as an infusion into a vein. Inebilizumab will be given at a dose of 300 mg on Day 1, Day 15, and Week 24. The study is double-blind, meaning that neither the participants nor the study team assessing them will know which treatment they receive.\n\nThe main research question is whether treatment with inebilizumab leads to a greater improvement in physical function (PF) than placebo. PF will be measured using the PF scale of the SF-36 health questionnaire, comparing the change from the start of the study to Month 9 (Week 36).\n\nThe study will also examine other aspects of health and daily functioning, including fatigue, post-exertional malaise, pain and headache, disability, symptoms related to the autonomic nervous system, muscle strength and fatigability, heart rate and blood pressure responses during standing, daily step count, and cognitive function. Adverse events will be monitored to assess the safety of the treatment. In addition, the study includes biomarker research focusing on B cells, autoantibodies, and other markers in the blood.\n\nThis research aims to explore biological characteristics that may be associated with response to treatment and may help inform future studies of B-cell-targeted treatment in PAIS and ME\u002FCFS.",[83,84,85],"Post-acute Infectious Syndrome (PAIS)","Post-COVID 19 Condition (PCC or Long COVID)","Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)",[87,88,89,90],"PAIS","Long COVID","ME\u002FCFS","Fatigue","NOT_YET_RECRUITING","2026-07-21",{"date":94,"type":95},"2026-07-24","ACTUAL",{"date":97,"type":77},"2026-12-01",{"date":99,"type":77},"2029-03-01",{"name":5,"class":6},1]