Baytown

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with advanced urothelial cancer that has spread locally or to other parts of the body. This phase III trial focuses on patients whose cancer has not responded to prior anti-PDL1 therapy. The study aims to compare overall survival, progression-free survival, response rates, duration of response, treatment side effects, and quality of life between the new combination therapy and usual chemotherapy care. Participants are randomly assigned to one of two treatment groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in 21-day cycles for up to six cycles or until disease progression or unacceptable side effects. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 every 21 days for up to 35 cycles or two years, unless disease progresses or side effects become unacceptable. Both groups undergo blood tests and imaging scans like CT or MRI throughout the study. During the trial, participants will have regular assessments including blood sample collection and imaging to monitor their cancer status and treatment effects. Researchers will also evaluate patient-reported quality of life and fatigue at multiple time points up to 12 months. After completing treatment, participants are followed up 30 days later and then annually for five years to track survival and health outcomes. This comprehensive approach helps researchers understand both the clinical outcomes and the impact on patients well-being over time.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

Researchers are evaluating vepugratinib, a new medicine, to see if it is safe and helpful for people with advanced or metastatic urothelial carcinoma, a type of bladder cancer with FGFR3 genetic changes. This Phase 3 study compares vepugratinib combined with enfortumab vedotin and pembrolizumab against a placebo combined with these same drugs. The trial is sponsored by Eli Lilly and Company and aims to assess treatment safety and effectiveness over a long period. Participants receive either vepugratinib or a placebo orally, together with enfortumab vedotin and pembrolizumab given by intravenous infusion. The study uses a double-blind, randomized design with parallel groups to compare these treatments. There is a safety lead-in phase followed by the main treatment phase, and study participation may last up to approximately 6 years. During the trial, participants will have regular assessments including monitoring for treatment-related side effects, tumor response, progression-free survival, overall survival, and quality of life using questionnaires. Researchers will collect blood samples to measure drug levels and evaluate health status at baseline and throughout the study. Safety and effectiveness outcomes will be tracked up to 90 months, with continuous monitoring to ensure participant well-being over the long-term study period.

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 safety and effectiveness of different doses of ELV001 in adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study plans to enroll about 180 to 220 participants and lasts 32 weeks from screening to the end of the study. The study aims to understand how ELV001 affects disease activity scores and other health measures in this patient group. Participants are divided into four groups receiving either placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. The study includes a 4-week screening period, followed by a 12-week placebo-controlled treatment phase. After week 12, all participants receive ELV001 at 75 mg or 125 mg doses during a treatment extension lasting until week 24. This is followed by a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including disease activity scoring, joint counts, health questionnaires, blood tests, ECGs, and vital sign monitoring up to week 28. The main measurement is the change in disease activity score from baseline to week 12. Safety outcomes such as adverse events and laboratory results will be tracked up to 32 weeks. Participants will be closely monitored for response and side effects during the entire 32-week study duration.

Researchers are evaluating how well elritercept works to improve anemia in adults with myelofibrosis MF who are already taking ruxolitinib. The study compares elritercept to a placebo and aims to see if elritercept can reduce tiredness, improve MF-related symptoms, and help participants perform physical activities more easily. It also looks at elritercepts effects on bone marrow, spleen size, antibody development, and long-term safety. Participants receive either elritercept or a placebo by subcutaneous injection once every 4 weeks during a 36-week double-blinded treatment period. The starting dose of elritercept is 3.75 mgkg, with a possible increase to 5.0 mgkg after the second cycle based on response and safety. After 36 weeks, participants who took placebo may switch to receive elritercept in an extended open-label phase. During the study, participants undergo assessments including blood transfusion independence, symptom and fatigue questionnaires, spleen imaging, and bone marrow evaluation. Researchers monitor safety, antibody formation, and survival for up to 7 years. The main outcome is the proportion of participants who become independent from red blood cell transfusions for at least 12 consecutive weeks during the 36-week treatment. Participants are involved in regular visits and evaluations throughout the treatment and follow-up periods.

Researchers are evaluating elritercept for its ability to reduce the need for red blood cell RBC transfusions and its safety compared to epoetin alfa in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who require regular blood transfusions. The study aims to understand if elritercept improves tiredness, lowers transfusion burden, enhances quality of life, and elicits an immune response. Participants receive either elritercept or epoetin alfa injections. Elritercept is given as a subcutaneous injection starting at 3.75 mgkg every 4 weeks, with possible dose increases to 5.0 mgkg. Epoetin alfa is administered as a subcutaneous injection starting at 450 IUkg once weekly, with possible dose escalation up to 1050 IUkg. The study follows participants for approximately 5 years to monitor treatment effects and safety. During the trial, participants are regularly assessed for transfusion independence, hemoglobin levels, fatigue, quality of life, and hematological improvements. Researchers monitor blood samples for drug concentration and immune response. Safety is evaluated through medical history, lab tests, and adverse event tracking. The main outcome is the proportion of participants achieving RBC transfusion independence for at least 12 weeks during the first 24 weeks. The study uses questionnaires and clinical assessments to measure fatigue and quality of life.