Bytom

Researchers are investigating new treatments for rheumatoid arthritis (RA), a condition where current therapies like methotrexate (MTX) may not fully control symptoms for many people. This Phase 2b study evaluates a medicine called tulisokibart to see if it can better reduce RA symptoms in individuals already taking MTX. The trial aims to determine if one or more doses of tulisokibart work better than a placebo, which looks like the medicine but contains no active drug. The study includes a 12-week period where participants receive either tulisokibart or a placebo by subcutaneous injection while continuing their MTX treatment, which can be given by injection or orally. Following this, there is a long-term extension lasting 116 weeks, composed of a 44-week main extension and a 72-week optional extension, to further assess the medication's effects and safety over time. Participants will undergo assessments to measure treatment response, including the American College of Rheumatology 20% response criteria at week 12 to gauge symptom improvement. Throughout the study, researchers will monitor for safety and effectiveness, with evaluations extending through the long-term extension periods, totaling over two years of participation.

Researchers are studying the effectiveness and safety of CC-97540, a CD19-targeted NEX-T CAR T cell therapy, in people with active systemic lupus erythematosus (SLE), including lupus nephritis. This phase 2, open-label trial focuses on participants who have not responded well to glucocorticoids and at least two immunosuppressant treatments. The goal is to assess whether CC-97540 can help achieve drug-free remission of SLE symptoms within six months. Participants receive CC-97540 along with specified doses of fludarabine and cyclophosphamide on certain days as part of the treatment. The study involves multiple centers and includes patients with active disease despite current treatment. The dosing schedule and exact administration details are defined to evaluate the therapy's effects and monitor drug levels. During the study, participants are closely monitored for safety and response to treatment. Researchers measure the proportion of participants who reach remission without the need for drugs by month six. The study includes assessments of disease activity and organ function, with ongoing observation to understand the therapy's impact on lupus symptoms and potential side effects over time.

Researchers are assessing the safety, tolerability, best dose, and early effectiveness of BMS-986515, a healthy donor allogeneic CD19-targeted CAR T cell therapy, in adults with severe and treatment-resistant autoimmune diseases. This Phase 1, multicenter, open-label study includes participants diagnosed with systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, or rheumatoid arthritis who have not responded well to standard treatments. Participants receive BMS-986515 along with other medications including fludarabine, cyclophosphamide, and tocilizumab, given at specified doses on planned days. The study focuses on finding the optimal dosing schedule and monitoring how the body reacts to the treatment over time. Throughout the study, participants will be closely monitored for any side effects or adverse events up to 24 months after receiving the BMS-986515 infusion. Researchers will track treatment-emergent and serious adverse events, laboratory abnormalities, and dose-limiting toxicities. The study will also assess safety signals during a 28-day evaluation period after infusion, with continuous follow-up to understand the therapy's impact and safety profile.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating the efficacy and safety of Afimkibart (also known as RO7790121) compared with a placebo in adults with moderate to severe rheumatoid arthritis (RA) who have not responded adequately or cannot tolerate tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors. This Phase II, multicenter, double-blind, placebo-controlled study focuses on participants who have active RA with specific joint swelling and tenderness, and who meet established RA classification criteria. Participants will receive either Afimkibart or placebo administered as a subcutaneous injection. The treatments are given to compare how well Afimkibart works against the placebo in reducing disease activity in RA patients with an inadequate response or intolerance to prior treatments. The study carefully monitors responses over a fixed timeline, including evaluations at baseline and Week 14. During the study, participants will undergo assessments measuring changes in the Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) from baseline to Week 14. Researchers will monitor safety and efficacy through physical exams, laboratory tests, and other clinical evaluations. The study excludes individuals with certain prior treatments or medical conditions to ensure participant safety and reliable results.

Researchers are evaluating the efficacy, pharmacokinetics, safety, and immunogenicity of MB04, a proposed etanercept biosimilar, compared to Enbrel4 (EU-sourced) in adults aged 18 to 75 years with active moderate to severe rheumatoid arthritis despite methotrexate therapy. This Phase 3 study includes approximately 458 patients who have been on a stable methotrexate dose for at least 8 weeks before randomization. The goal is to compare these treatments over time to understand their effects in this patient population. Participants will be randomly assigned in a 1:1 ratio to receive either MB04 or EU-sourced Enbrel4 as a 50 mg subcutaneous injection once weekly during the main treatment period. After completing 24 weeks of treatment, those initially receiving Enbrel4 will be re-randomized to either continue Enbrel4 or switch to MB04 until week 36. Patients who started on MB04 will continue the same treatment through week 36. All participants will continue their stable methotrexate and folic acid regimen throughout the study. Participants will undergo screening within 28 days before randomization and will be monitored through week 40, including a 4-week safety follow-up after treatment ends. Researchers will assess treatment response using the American College of Rheumatology 20% Response Criteria (ACR20) at week 24, along with safety, pharmacokinetics, and immunogenicity evaluations. Regular assessments and monitoring will help determine how patients respond to the treatments and ensure their safety throughout the study.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.

This research aims to compare two ways of giving the drug bimekizumab to adults with active psoriatic arthritis or active axial spondyloarthritis. The study focuses on whether giving bimekizumab through an intravenous (IV) injection is not worse than giving it as a subcutaneous (under the skin) injection. The trial is designed as an open-label, randomized, parallel-group, noninferiority phase 1 study to evaluate how the drug moves and stays in the body over time. Participants will receive bimekizumab at scheduled times either through one of two intravenous regimens or a subcutaneous regimen. Each group will follow a specific dosing plan to see how the drug behaves in the body depending on the method of administration. The study treatments are given at pre-set time points, and the goal is to measure drug concentrations in the blood. During the study, participants will be monitored and assessed for the drug concentration in their blood at week 16 to understand steady-state trough levels. Researchers will also check for safety and tolerability throughout the study. The total duration and further assessments are not specified, but the focus is on comparing the drug levels and safety between the different administration methods in adults with these active conditions.

Researchers are collecting real-world data from multiple centers in Poland to understand how anifrolumab is used and how patients with systemic lupus erythematosus (SLE) respond to this treatment in routine clinical practice. The study focuses on adults with SLE who are receiving anifrolumab as part of the National Drug Program (NDP) and aims to observe their clinical outcomes over time. Participants will receive anifrolumab 300 mg through infusion, as prescribed in their regular care. The observational study follows patients for up to 30 months, including about 6 months before starting anifrolumab and approximately 24 months of follow-up after treatment begins. No additional treatments or interventions are assigned as part of this study. During the study, researchers will monitor disease activity using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, particularly noting changes at 12 months. Patients will be regularly assessed as per standard clinical care, with data collected about their health status and treatment outcomes throughout the study period.