Bytom

Researchers are studying BMS-986515, a healthy donor allogeneic CD19-targeted CAR T cell therapy, to assess its safety, tolerability, best dosing, and early effectiveness in adults with severe, treatment-resistant autoimmune diseases. This phase 1 trial focuses on participants with refractory autoimmune conditions such as systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, and rheumatoid arthritis who have not responded adequately to standard treatments. Participants receive BMS-986515 along with drugs including fludarabine, cyclophosphamide, and tocilizumab in specified doses given on set days. The study is designed as a single group intervention evaluating the investigational cellular therapys impact and safety profile over time, with close monitoring following the infusion of the CAR T cells. During the trial, participants will undergo extensive safety and response assessments up to 24 months after receiving BMS-986515. Researchers will track adverse events, laboratory results, and signs of disease remission or activity using specific clinical criteria and questionnaires. The study includes long-term follow-up to evaluate ongoing effects and tolerability of the treatment.

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 compared with placebo in adults with moderate to severe rheumatoid arthritis RA who have not responded well to or cannot tolerate tumor necrosis factor TNF inhibitors andor Janus kinase JAK inhibitors. This Phase II, double-blind, placebo-controlled study aims to better understand how Afimkibart works for patients with this challenging form of RA. Participants in this study will receive Afimkibart or a matching placebo by subcutaneous injection. The study uses a randomized, parallel design with multiple groups receiving either Afimkibart or placebo. Dosing schedules and injection details are consistent across groups, with treatment effects assessed over a period including baseline, Week 14, and Week 24 timepoints. The study also includes monitoring of drug concentration and immune response markers up to Week 38. During the study, participants will be regularly assessed for changes in RA disease activity using scores such as DAS28-CRP and DAS28-ESR, joint counts, global assessments, pain levels, disability questionnaires, and inflammation markers. Safety is monitored through adverse event tracking and antibody testing. The total study duration includes treatment and follow-up periods lasting up to 38 weeks, allowing researchers to evaluate both short- and longer-term effects of the study drug.

Researchers are evaluating the proposed biosimilar MB04 compared to Enbrel, a known treatment, in patients with moderate to severe rheumatoid arthritis RA who continue to have active disease despite methotrexate therapy. The study aims to assess the effectiveness, safety, how the body processes the drugs, and immune responses to MB04 versus Enbrel. This phase 3 trial will include approximately 458 patients aged 18 to 75 years. Participants will receive a stable dose of methotrexate and folic acid before starting the study. They will be randomly assigned to receive a 50 mg weekly subcutaneous injection of either MB04 or EU-sourced Enbrel during the 36-week main treatment period. After 24 weeks, some patients initially on Enbrel will be re-randomized to either continue Enbrel or switch to MB04, while those on MB04 will continue the same treatment. Following treatment, patients will be monitored for safety for an additional 4 weeks. Throughout the study, patients will undergo regular assessments including measures of joint swelling and tenderness, and blood tests to evaluate inflammation and immune response. The primary outcome is the American College of Rheumatology 20% Response Criteria ACR20 at Week 24, with additional assessments at Week 36. Safety will be monitored continuously, and participant involvement will last approximately 40 weeks including follow-up.

Researchers are evaluating BMS-986365 compared to the investigators choice of therapy in men with Metastatic Castration-resistant Prostate Cancer. This phase 3, randomized trial aims to assess how well BMS-986365 works and how safe it is, focusing on radiographic progression-free survival. The study includes participants who have previously been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants are randomized into groups receiving either one of two dose levels of BMS-986365 or an active comparator treatment chosen by the investigator, which includes either Docetaxel plus PrednisonePrednisolone or Enzalutamide or Abiraterone plus PrednisonePrednisolone. The study has two parts Part 1 compares the different doses and comparator arms, while Part 2 focuses on the selected BMS-986365 dose versus the investigators choice. Dosing schedules are specified but not detailed here. During the study, participants undergo regular assessments including imaging scans to evaluate cancer progression, pain and symptom questionnaires, blood tests, electrocardiograms, and monitoring for adverse events. Outcomes measured include progression-free survival, overall survival, response rates, pain progression, and quality of life changes. The study may last up to 4 years, with ongoing safety and efficacy evaluations throughout this time.

Researchers are evaluating bimekizumab administered intravenously compared to subcutaneous injection in adults with active psoriatic arthritis or active axial spondyloarthritis. The study aims to show that the intravenous method is not less effective than the subcutaneous method by assessing how the drug moves in the body over time. This is a Phase 1, open-label, randomized, parallel-group study focused on treatment. Participants will receive one of three dosing regimens of bimekizumab during a pharmacokinetics lead-in phase and continue with the same assigned regimen during the treatment period. The dosing regimens include intravenous and subcutaneous administration of bimekizumab at specified times. Subjects are randomized into one of two experimental arms reflecting different intravenous regimens or a third arm receiving the subcutaneous regimen. During the study, participants will be monitored for steady-state trough concentration of the drug at week 16. Safety is assessed by tracking treatment-emergent adverse events, serious adverse events, and any events leading to withdrawal from the study through week 29. The study duration extends to the end of safety follow-up, with regular assessments to evaluate drug levels and participant health under medical supervision.

Researchers are evaluating KBP-336, a drug designed to treat knee pain caused by osteoarthritis in people who are also living with obesity. This Phase 2 clinical trial aims to find out if KBP-336 can reduce pain and body weight compared to a placebo, while also assessing its effects on quality of life, metabolism, and safety. The study is sponsored by KeyBioscience AG and focuses on adults aged 45 years and older with diagnosed osteoarthritis of the knee and obesity. Participants in this study will receive weekly subcutaneous injections of KBP-336 or a placebo for six months. The study compares multiple dosages of KBP-336 against placebo, with participants visiting the clinic every two weeks for checkups and tests. Throughout the trial, participants will maintain a diary recording their symptoms and use of any additional pain medications allowed as rescue treatment. During the study, participants will be regularly assessed using several tools, including the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC for pain, stiffness, and function, as well as quality of life questionnaires AQol 8D. Researchers will monitor changes in body weight, pain levels, body composition, bone density, and medication use over 183 days. Safety and well-being will be closely observed through physical exams, vital signs, ECGs, and lab tests, with the total trial duration lasting about six months for each participant.

This trial focuses on adults aged 64 and older who have moderate-to-severe primary knee osteoarthritis, a condition where joint cartilage breaks down and causes chronic inflammation and pain. The study evaluates the effects of Allocetra, an immunomodulatory cell-based therapy, compared to a placebo. Allocetra consists of specially modified allogeneic blood cells designed to reprogram immune cells and potentially reduce inflammation in the knee joint. Participants are randomly assigned to receive either Allocetra or a placebo through three ultrasound-guided injections into the affected knee on Days 0, 14, and 28. The study lasts for 12 months, with follow-up visits to monitor outcomes over this period. The trial is double-blind, meaning neither participants nor researchers know who receives Allocetra or placebo during the study. During the trial, participants will have assessments including pain and function evaluations using the Western Ontario and McMaster Universities Arthritis Index WOMAC at 3 and 6 months. Safety monitoring will continue for six months. Other measures such as quality of life and daily pain scores will also be collected. The study aims to understand Allocetras impact on knee osteoarthritis symptoms and safety over one year of observation.

Researchers are evaluating the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus SLE who have previously completed treatment in one of two core SIRIUS-SLE studies. This Phase 3 extension study compares monthly or quarterly subcutaneous ianalumab to monthly placebo in participants who are positive for anti-nuclear antibodies ANA. The study aims to understand how ianalumab performs over an extended period in this patient group. Participants receive ianalumab either monthly or quarterly via subcutaneous injection, or a monthly placebo injection, throughout the extension study. Only those who completed the initial 60-week treatment period of the core studies without discontinuation are eligible. The study involves random assignment to one of the three groups and follows a quadruple-blind design to ensure unbiased results. During the trial, participants are monitored for treatment-emergent adverse events and serious adverse events up to approximately 91 months. Researchers also assess lupus disease activity, damage progression, corticosteroid use, and flare rates. Safety and tolerability are closely observed through regular evaluations, with the study lasting until April 2032, allowing for comprehensive long-term data collection.