Zhumadian

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers are evaluating the efficacy and safety of SAR441566 in adults with moderate-to-severe ulcerative colitis, a chronic inflammatory bowel condition. This Phase 2, multinational, randomized, double-blind, placebo-controlled study aims to assess how different doses of SAR441566 affect clinical remission in participants. The study includes participants aged 18 to 75 years who have active moderate-to-severe ulcerative colitis confirmed by endoscopy and who have previously received treatment for the condition. Participants will be randomly assigned to receive one of three different dose regimens of SAR441566 or a matching placebo. The medication is administered orally as tablets. The study includes a screening period of up to 28 days, followed by a main treatment period lasting 52 weeks. This treatment period is divided into a 12-week induction phase and a 40-week maintenance phase, followed by a 2-week follow-up after treatment ends. Additionally, eligible participants may enter an open-label extension period lasting up to 40 weeks. During the study, participants will attend up to 12 visits in the main treatment phase and up to 8 visits during the open-label period. Researchers will assess clinical remission using the modified Mayo Score at Week 12, along with various secondary measures such as endoscopic remission, patient-reported outcomes, and safety evaluations. Blood samples will be taken to measure drug concentrations, and adverse events will be monitored throughout the study. The total participation duration can be up to 59 weeks, including screening, treatment, and follow-up.

Researchers are studying the effectiveness of riliprubart compared to intravenous immunoglobulin IVIg in adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP who are already receiving IVIg maintenance treatment. This Phase 3 trial aims to evaluate how well riliprubart works and its safety over a study period lasting up to 109 weeks, including screening, treatment, and follow-up phases. Participants are randomly assigned to one of two groups one receives riliprubart along with a placebo IVIg infusion for 24 weeks, followed by a 24-week open-label extension phase where all receive riliprubart the other group continues IVIg treatment with a placebo riliprubart for 24 weeks, then also enters the open-label extension phase receiving riliprubart. The study uses intravenous and subcutaneous solutions for administration and includes a double-blind design to compare treatments fairly. During the study, participants undergo various assessments including disability scales, grip strength measurements, fatigue scales, and health quality evaluations from baseline up to week 48 and beyond. Researchers will monitor treatment responses, relapses, adverse events, and immune responses throughout the trial. Participants are followed closely for safety and effectiveness until the study concludes, with total involvement lasting up to 109 weeks.

Researchers are evaluating the safety and effectiveness of perfusion-guided endovascular treatment EVT compared to standard medical care for adults who have had an acute ischemic stroke caused by medium vessel occlusion within 24 hours of symptom onset. This study focuses on patients with specific artery blockages confirmed by imaging and a baseline stroke severity score of 8 or higher. The goal is to see how well patients recover by measuring their ability to function independently 90 days after treatment. Participants will be randomly assigned to one of two groups one receiving endovascular treatment plus best medical treatment, and the other receiving best medical treatment alone. The endovascular treatment involves techniques such as thrombectomy, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or combinations of these, performed immediately after randomization. Best medical treatment follows current clinical guidelines and is administered independently of the study treatment. During the study, participants will undergo neuroimaging to confirm eligibility and will be monitored regularly for neurological improvement, safety events, and overall recovery using scales like the modified Rankin Scale at 90 days and one year. Researchers will collect data on stroke severity, quality of life, bleeding complications, and mortality. The study starts in February 2026 and continues until September 2028, with participant follow-up lasting at least one year after treatment.

Researchers are evaluating the differences between subcutaneous SC and intravenous IV administration of frexalimab in adults aged 18 to 60 years with relapsing multiple sclerosis RMS and non-relapsing secondary progressive multiple sclerosis nrSPMS. This Phase 3, randomized, open-label study aims to compare the pharmacokinetics, safety, and efficacy of these two methods of delivering frexalimab over a one-year period. Participants include males and females diagnosed with MS who meet specific clinical criteria related to their disease type and progression. Participants will be randomly assigned to receive frexalimab either as an SC injection every 4 weeks using a home self-administration on-body delivery system after training and agreement starting from Part B or as an IV infusion every 4 weeks. The treatment duration covers 48 weeks for the first two parts of the study, with an optional third part continuing until the start of a long-term safety study. Regular visits occur monthly between weeks 4 and 24, then less frequently up to the end of the study, with follow-up visits for those who discontinue treatment early. During the study, participants will attend up to 17 scheduled visits and undergo assessments including MRI scans with contrast, blood tests to measure drug levels and immune responses, and evaluations of disability progression. Researchers will monitor adverse events, the presence of antibodies to the drug, and participant preferences for SC versus IV administration. Follow-up continues for six months after treatment ends to assess long-term safety and outcomes. The study collects data on pharmacokinetics and clinical effects at multiple timepoints up to week 96 and beyond for some participants.