Baytown

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjögren's 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 studying the safety and effects of combined doses of ensifentrine and glycopyrrolate in adults with chronic obstructive pulmonary disease (COPD). This Phase IIb trial compares two doses of the combination to each drug alone and to a placebo, aiming to evaluate their ability to improve lung function in adults aged 40 to 80 years with COPD symptoms and a history of smoking. Participants will be randomly assigned to one of six groups: two groups will receive fixed combinations of ensifentrine 3 mg with either 21.25 mcg or 42.5 mcg glycopyrrolate; two groups will receive glycopyrrolate alone at one of the two doses; one group will receive ensifentrine alone; and one group will receive a placebo. All treatments are inhaled twice daily using a standard jet nebulizer over a 28-day period. The study lasts about seven weeks, including 1 to 2 weeks for screening, 4 weeks of treatment, and a 1-week follow-up. Participants will undergo lung function tests measuring forced expiratory volume in one second (FEV1) at various time points and complete questionnaires about symptoms and quality of life. Researchers will monitor safety, lung function changes, symptom improvements, and adverse events throughout the study.

Researchers are evaluating the combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.

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 two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This phase 2 study focuses on how these medications work alone or in combination for people who have had UC for at least three months and have not responded well or tolerated previous treatments. The trial is sponsored by Eli Lilly and Company and aims to improve treatment options for this condition. Participants may receive eltrekibart alone, mirikizumab alone, both drugs together, or placebos in various combinations. The study uses a randomized, double-blind design to compare these different treatment groups. The trial lasts about 69 weeks, including a screening period up to 35 days before enrollment. Treatments are administered throughout the study, with doses adjusted as needed to assess safety and effectiveness. During the trial, participants will undergo regular assessments including clinical remission rates at 12 and 52 weeks, endoscopic and histologic evaluations, and quality of life questionnaires. Blood tests will measure drug levels to monitor pharmacokinetics. Safety and response to treatment will be closely monitored throughout the study, which spans approximately 4 to 5 years in total. Participants will have multiple visits for evaluations to track their progress and any side effects.

Researchers are evaluating the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has a specific genetic mutation called PIK3CA. This phase 3 study aims to assess both the effectiveness and safety of this combination treatment. Participants can remain in the study as long as the treatment is helping control the cancer without causing unbearable side effects. Participants will receive Tersolisib orally in combination with an oral CDK4/6 inhibitor and endocrine therapy (ET), which may be given orally or by intramuscular injection. The study includes different groups: one receiving two different doses of Tersolisib plus CDK4/6 inhibitor and ET, another receiving one dose of Tersolisib plus CDK4/6 inhibitor and ET, and a placebo group receiving placebo with CDK4/6 inhibitor and ET. The CDK4/6 inhibitors used include ribociclib, palbociclib, or abemaciclib, while ET options include anastrozole, letrozole, exemestane, or fulvestrant. During the study, participants will undergo evaluations that include measuring tumor response, progression-free survival, overall survival, and quality of life using questionnaires. Researchers will monitor participants regularly through scans, lab tests, and clinical assessments to track treatment response and side effects. The study may last up to 7 years to observe long-term outcomes, and participants will be closely followed to assess how the cancer responds and how the treatments affect their health and well-being over time.

Researchers are studying vepugratinib, a new medicine, to see if it is safe and helpful for people with advanced or metastatic bladder cancer that has a specific FGFR3 genetic alteration. This phase 3 study compares vepugratinib combined with enfortumab vedotin and pembrolizumab against a placebo combined with the same drugs. The trial aims to evaluate safety and effectiveness over a long period. Participants receive either vepugratinib or placebo orally, along with enfortumab vedotin and pembrolizumab administered by intravenous infusion. There is a safety lead-in period and then randomized treatment groups. The study is double-blind and placebo-controlled, with treatment continuing for up to about 6 years. During the study, participants will have regular assessments to monitor treatment safety, responses, and disease progression. Researchers will measure adverse events, overall response rates, progression-free survival, and quality of life using standard criteria. Blood samples will be taken to check drug levels. The trial includes long-term follow-up to observe outcomes and side effects over time.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition affecting the joints and skin in people with psoriasis. This study aims to understand how well the drug zasocitinib (TAK-279) works in adults with active PsA who have never been treated with biologic disease-modifying antirheumatic drugs. Participants will be involved in this Phase 3 trial to evaluate the drug's effects and safety. Participants will be randomly assigned to one of several groups receiving different treatments. Some will take zasocitinib Dose A or Dose B tablets once daily for up to 52 weeks. Others will receive an active comparator capsule twice daily for up to 52 weeks. A placebo group will take placebo once daily for 16 weeks, then switch to zasocitinib Dose A or B from Week 16 to Week 52. This design allows comparison between the new drug, an active treatment, and placebo. During the study, participants will have regular visits and assessments to monitor their joint and skin symptoms. Researchers will measure responses using criteria like the American College of Rheumatology 20 (ACR20) response at Week 16, among other disease activity and quality of life assessments. The study duration for each participant can last up to 60 weeks, including treatment and follow-up to evaluate the drug's impact and safety.

Researchers are evaluating ELV001, a drug being studied as an add-on therapy for 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 aims to assess the safety and effectiveness of different doses of ELV001. Approximately 180 to 220 participants aged 18 to 75 with active rheumatoid arthritis will be enrolled to better understand the drug's impact on disease activity. The study has four groups: a placebo group and three groups receiving ELV001 at doses of 25 mg, 75 mg, or 125 mg daily. The study includes a 4-week screening period, a 12-week double-blind treatment period where participants receive their assigned treatment, followed by a 12-week treatment extension phase. In the extension, those initially on placebo or 25 mg switch to 75 mg or 125 mg doses. The study concludes with a 4-week safety follow-up. Participants will attend regular visits for assessments including disease activity scores, joint counts, patient questionnaires, vital signs, laboratory tests, ECGs, and blood samples for drug levels. Researchers will monitor side effects and measure changes in disease symptoms up to 32 weeks. The main outcome focuses on the change in disease activity score from baseline to week 12, with additional evaluations through week 24 and safety monitoring continuing through week 28.

Researchers are evaluating elritercept compared to epoetin alfa to treat anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular red blood cell (RBC) transfusions. The study aims to assess how elritercept affects the need for RBC transfusions, its safety, and whether it improves tiredness and quality of life compared to epoetin alfa. The trial also explores the immune response to elritercept and monitors medical problems related to the treatment. Participants will be randomly assigned to receive either elritercept or epoetin alfa. Those receiving elritercept will start with a dose of 3.75 mg/kg by subcutaneous injection every 4 weeks, which may be increased to 5.0 mg/kg if necessary. Participants receiving epoetin alfa will start at 450 IU/kg by subcutaneous injection once weekly, with possible dose escalation up to 1050 IU/kg. Treatment will continue with monitoring over several cycles, each lasting 28 days, with assessments up to 48 weeks and potential follow-up to about 5 years. During the study, participants will have regular visits to assess their need for RBC transfusions, hemoglobin levels, fatigue using the FACIT-Fatigue Scale, quality of life through questionnaires, and blood tests to monitor drug levels and immune response. The main outcome is the proportion of participants who become independent of RBC transfusions for at least 12 consecutive weeks with improved hemoglobin. Safety and overall health will be closely monitored, including tracking any progression to acute myeloid leukemia or death. The total participation duration may last up to several years to evaluate long-term effects.