Ube

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the safety and tolerability of ASP3082 in adults with advanced solid tumors that have a specific KRAS G12D mutation. This open-label Phase 1 study includes patients with locally advanced or metastatic solid tumors who have received prior standard therapies or are ineligible for them. The study is conducted in two parts to identify suitable doses of ASP3082 alone or combined with cetuximab. In Part 1, small groups of participants receive escalating doses of ASP3082 alone or with cetuximab through intravenous infusion. A medical panel reviews safety data after each group to decide on dose escalation. In Part 2, participants receive ASP3082 alone or with other study treatments, including various chemotherapy drugs, also by infusion. Treatments are given in cycles lasting 21 or 28 days and continue until intolerable side effects, disease progression, new treatments, or participant withdrawal. Participants will undergo regular assessments including physical exams, laboratory tests, ECGs, and performance status evaluations to monitor safety and treatment effects for up to 48 months. Researchers will track adverse events, dose-limiting toxicities, and overall health status throughout the study. Participants must provide tumor samples and may have biopsies during treatment. The study involves ongoing monitoring to assess the impact and safety of ASP3082 over time.

Researchers are evaluating the safety and effectiveness of baricitinib, a medication taken by mouth, for treating severe or very severe alopecia areata, a type of hair loss, in children aged 6 to less than 18 years. This Phase 3 study involves children and adolescents who have had alopecia areata for at least one year and are experiencing a current episode lasting at least six months with significant hair loss. The study aims to see how well baricitinib works compared to a placebo. The study is divided into four distinct periods: a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive either baricitinib or placebo, an approximately 2-year long-term extension period for continued treatment, and a 4-week post-treatment follow-up period to monitor participants after stopping the medication. Both baricitinib and placebo are administered orally. Participants will undergo various assessments throughout the study, including measuring the severity of hair loss using the Severity of Alopecia Tool (SALT) score. The main outcome is the percentage of participants achieving a SALT score of 20 or less after 36 weeks of treatment. Safety and pharmacokinetics of baricitinib will also be monitored during the study. The total participation may last over two years, including treatment and follow-up phases.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the effects of guselkumab, a medication targeting the IL-23 pathway, in children aged 2 to 17 years with moderately to severely active Crohn's Disease. This Phase 3 study aims to assess both clinical and endoscopic improvement by the end of one year of treatment, focusing on participants who responded to guselkumab after 12 weeks. Participants receive guselkumab either as an injection under the skin or through an intravenous infusion. The study measures effectiveness at Week 52, following initial response at Week 12, to determine remission rates and healing observed via endoscopy. Throughout the study, children will be closely monitored with clinical assessments, endoscopic exams, and evaluation of disease activity scores. Researchers will track safety and treatment response over the 52-week period to understand guselkumab's role in managing pediatric Crohn's Disease.

Researchers are evaluating mirikizumab in children and adolescents aged 2 to 17 years with Crohn's disease, including those with fistulizing disease and active inflammation in the colon, ileum, or both. This Phase 3 study aims to assess how well mirikizumab works, its safety, tolerability, and how it is absorbed in the body for pediatric participants who have moderately to severely active Crohn's disease and a history of inadequate response or intolerance to other treatments. Participants will be randomly assigned to receive mirikizumab either intravenously or by injection under the skin. The study consists of a 12-week induction period to start treatment, followed by a maintenance period lasting up to Week 52, and a safety follow-up period continuing for up to 16 weeks after treatment. The entire study will last about 74 weeks and may include up to 19 visits for treatment and assessments. During the study, participants will undergo evaluations including endoscopy to assess disease activity, clinical assessments using the Pediatric Crohn's Disease Activity Index (PCDAI), and monitoring for treatment response and remission at Weeks 12 and 52. Safety and tolerability will be closely followed throughout the study and during the safety follow-up. The main outcomes measured are the percentage of participants achieving clinical and endoscopic response over the study period.

Researchers are investigating the effectiveness and safety of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as first-line treatments for patients with advanced biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma. This is a global, phase III, randomized, open-label study focused on patients with unresectable locally advanced or metastatic disease who have not previously received treatment for advanced cancer. The study includes patients with known PD-L1 status and measurable tumors suitable for repeated evaluation. Participants will receive either rilvegostomig intravenously every three weeks along with gemcitabine and cisplatin given intravenously on days 1 and 8 of each 21-day cycle, or durvalumab intravenously every three weeks for up to eight cycles, followed by dosing every four weeks, along with the same chemotherapy regimen. Treatment is designed to evaluate first-line therapy effects, comparing these two immunotherapy combinations alongside standard chemotherapy. Throughout the study, patients will be closely monitored for overall survival, especially in those with PD-L1 expression of 1% or higher, over approximately four years. Assessments will include tumor measurements by CT or MRI using RECIST 1.1 criteria, performance status evaluations, and ongoing safety monitoring. The study aims to understand the impact of these treatments on survival and disease progression in advanced biliary tract cancer patients.

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

This research evaluates the effects of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. The study is a Phase 3 trial aiming to assess the safety and effectiveness of these treatments. Participants must meet specific CIDP diagnostic guidelines and have shown response to IVIg in the past five years. The study is divided into two parts. In Part A, lasting 24 weeks (6 months), participants receive either empasiprubart with a placebo mimicking IVIg, or IVIg with a placebo mimicking empasiprubart. Following this, Part B lasts 96 weeks (24 months), during which all participants receive empasiprubart. Both treatments are given by intravenous infusion. Placebos are used to maintain blinding in the study. Participants will be monitored for changes in their disease symptoms, particularly focusing on improvements measured by a reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Throughout the study, safety and disease activity will be regularly assessed. The total study duration for participants is up to 120 weeks, including both treatment parts.