[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-sclerosis-in-adults\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-sclerosis-in-adults":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100657701","phase-2-obinutuzumab-in-systemic-sclerosis-100657701",false,"NCT07842523","Obinutuzumab in Systemic Sclerosis","Safety and Efficacy of Obinutuzumab in Systemic Sclerosis: a Phase II, Randomized, Double-blinded Versus Placebo-controlled Trial\"","OBINUSS","Inclusion Criteria:\n\n* Adult patient (\\>\u002F= 18 years old),\n* Patient with a diagnosis of SSc, as defined by the American College of Rheumatology \u002F EULAR 2013 criteria,\n* Patient with a diffuse SSc, as defined according to Leroy et al.\n* Patient with a SSc disease duration of less than 8 years (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score,\n* Patient with a modified Rodnan skin score (mRSS) \\> \u002F= 10 and \\\u003C \u002F= 35 units at screening,\n* Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception during the treatment period and up to 18 months after stopping it Women are considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient\n* Patient able to give written informed consent prior to participation in the study,\n* Affiliation to a social security scheme (profit or being entitled).\n* If patients receive mycophenolate or methotrexate for SSc, these need to be on stable dose as follows:\n\nMycophenolate mofetil\u002Fsodium: stable dose for at least 2 months prior to randomisation Methotrexate: stable dose and route of administration for at least 2 months prior to randomisation\n\n\\- Anti-fibrotic drugs such as nintedanib is permitted\n\nExclusion Criteria\n\n* Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy such as, but not limited to, obinutuzumab, rituximab, ocrelizumab, ofatumumab, or bortezomib less than 9 months prior to screening or during screening. If anti-CD20 or anti-CD19 therapy has been received between 9 and 12 months prior to screening, the peripheral CD19+ B-cell count must be over 25 cells\u002FμL\n* Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening\n* Any biologic therapy (other than anti-CD20, anti-CD19, or anti-plasma cell) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening\n* Inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening\n* Any live vaccine during the 28 days prior to screening or during screening\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions during the 28 days prior the screening\n* Active infection with SARS-CoV-2 or patients not fully vaccinated following national recommendations against SARS-CoV-2\n* Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation\n* HIV infection: for participants with unknown HIV status, HIV testing will be performed locally at screening if required by local regulations.\n* Active infection of any kind, excluding fungal infection of the nail beds. Any major episode of infection that also fulfills any of the following criteria:\n\n  * Requires hospitalization during the 8 weeks prior to screening or during screening\n  * Requires treatment with IV antibiotics (or anti-infectives) during the 8 weeks prior to screening or during screening\n  * Requires treatment with oral antibiotics (or anti-infectives) during the 2 weeks prior to screening or during screening\n  * Antibiotics or anti-infectives given in the absence of a major episode of infection are not exclusionary.\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years (Participants with non-melanomatous carcinomas of the skin that have been treated or excised and have resolved are eligible).\n* Major surgery requiring hospitalization during the 4 weeks prior to or during screening\n* Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening\n* Intolerance or contraindication to study therapies, including any of the following:\n\n  \\*History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion\n* Any of the following laboratory parameters:\n\n  * AST or ALT above 2.5 upper limit normal range\n  * Neutrophils \\\u003C1.5x103\u002FmL\n  * Positive hepatitis B surface antigen (HBsAg) Participants who are HBsAg negative and hepatitis B core antibody (HBcAb) positive with no detectable hepatitis B virus (HBV) DNA are eligible but will require monthly HBV DNA monitoring until 12 months after the last dose of obinutuzumab or placebo.\n  * Positive hepatitis C serology Participants with positive hepatitis C antibody test result with no detectable hepatitis C virus (HCV) RNA for at least 6 months after completion of antiviral therapy are eligible but will require monthly HCV RNA monitoring until 12 months after the last dose of obinutuzumab or placebo.\n  * Hemoglobin below 7 g\u002FdL\n  * Platelet count below 50,000\u002FL\n* Pregnant or breastfeeding woman, or woman who refuses to use an effective contraception during the study course;\n* Protected adults (including individual under legal guardianship by court order or curatorship) or adults deprived of liberty;\n* Patient participating in another investigational therapeutic study in the 3 months preceding inclusion;\n* Patients treated with CAR-T cell immunotherapy","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to determine if obinutuzumab is effective in systemic sclerosis",[27],"Systemic Sclerosis in Adults",[29,30],"Systemic sclerosis","obinutuzumab","NOT_YET_RECRUITING","2026-09-21",{"date":34,"type":35},"2026-09-25","ACTUAL",{"date":37,"type":21},"2026-11",{"date":39,"type":21},"2030-06",{"name":41,"class":42},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100656643","phase-2-rituximab-vs-placebo-for-maintenance-in-systemic-sclerosis---interstitial-lung-disease-100656643","NCT07827742","Rituximab vs Placebo for Maintenance in Systemic Sclerosis - Interstitial Lung Disease","MAINRITSyS","Inclusion Criteria:\n\n* Adult patient (≥ 18 years old),\n* Patient with a diagnosis of SSc, as defined by the ACR\u002FEULAR 2013 criteria (cf. Table 2) (6)\n* Patient with ILD identified on the basis of a HRCT, obtained within 12 months before screening, that showed fibrosis affecting at least 10% of the lungs,\n* SSc-ILD induction with RTX, either twice 1000 mg two weeks apart, or 375 mg\u002Fm2 four times 4 weeks apart.\n\nThe interval between the last induction dose and the first maintenance dose should be 6 months +\u002F- 15 days.\n\n* Patient with stabilized SSc-ILD following RTX induction treatment as defined by the absence of worsening respiratory symptoms, an absolute decline of FVC of \\\u003C 5% of the predicted value, an absence of absolute decline of DLCO (corrected for hemoglobin) of \\\u003C 10% related to SSc-ILD, and absence of radiological evidence of disease progression on HRCT(97)\n* All required vaccinations must have been carried out at least 4 weeks before D0. According to recommendations, prophylaxis against pneumocystis is recommended for scleroderma, but not mandatory.\n* Woman of childbearing potential should have reliable contraception\\* for the 12 months' duration of the study's treatment and 12 months after last administration,\n* Patient able to give written informed consent prior to participation in the study,\n* Affiliation to a social security scheme (profit or being entitled). AME is not accepted.\n\nExclusion Criteria\n\n* Forced vital capacity \\\u003C 40% of the predicted value\n* Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) \\\u003C 30% of the predicted value.\n* Contra-indication or anaphylaxis toward RTX\n* Contra-indication to auxiliary medicinal products\n* Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening\n* Any biologic therapy (including other anti-CD20, anti-CD19, or anti-plasma cell) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening\n* Inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening\n* Any live vaccine during the 28 days prior to screening or during screening\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions during the 28 days prior the screening\n* Active infection with SARS-CoV-2 or absence of COVID-19 vaccination within the last six months (this criteria will be updated at the time of submission to European Agency to be in adequation with national recommendation at the time of submission).\n* Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation\n* HIV infection : for participants with unknown HIV status (if the previous tests date more than 3 months), HIV testing will be performed locally at screening.\n* Tuberculosis (TB) infection: Testing for latent TB will be performed locally at screening if required by local regulations or in accordance with local clinical practice. Latent TB after completion of appropriate treatment is not exclusionary\n* Active infection of any kind, excluding fungal infection of the nail beds.\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years. Participants with non-melanomatous carcinomas of the skin that have been treated or excised and have resolved are eligible.\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening\n* Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening\n* History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the RTX infusion\n* Any of the following laboratory parameters:\n\n  * AST or ALT above 2.5 upper limit normal range\n  * Neutrophils \\\u003C1.5x103\u002FmL\n  * Positive hepatitis B surface antigen (HBsAg)\n  * Positive hepatitis C serology Participants with positive hepatitis C antibody test result with no detectable hepatitis C virus (HCV) RNA for at least 6 months after completion of antiviral therapy are eligible but will require monthly HCV RNA monitoring until 12 months after the last dose of RTX or placebo.\n* Pregnancy or breastfeeding\n* Participation in another interventional study or being in the exclusion period at the end of a previous study.\n* Participants under court supervision, guardianship, or conservatorship.",{"count":20,"type":21},[24],"The purpose of this study is to determine whether Rituximab is safe and effective as a maintenance strategy in individuals with stabilized systemic sclerosis in adults.",[27],[29,56],"Rituximab","2026-09-14",{"date":59,"type":35},"2026-09-18",{"date":61,"type":21},"2026-10",{"date":63,"type":21},"2031-03",{"name":41,"class":42}]