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Found 7 Actively Recruiting clinical trials
Actively Recruiting
Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.
Actively Recruiting
Researchers are evaluating the efficacy and safety of the drug ICP-248 in adults with relapsed or refractory mantle cell lymphoma MCL, a type of cancer affecting the lymphatic system. This is an open-label, single-group, phase 2 study conducted at multiple centers. Participants must have failed previous treatments including anti-CD20 therapy and BTK inhibitors, and have measurable disease according to recognized criteria. Participants will receive ICP-248 orally following the study protocol. There is no comparator group as this is a single-arm study. The treatment period and follow-up extend up to three years, during which researchers will monitor response rates, disease control, survival, drug levels in the blood, and quality of life measures. These assessments will be conducted according to established lymphoma evaluation standards. Throughout the study, participants will undergo regular evaluations including imaging to measure tumor response, blood tests to assess drug levels and minimal residual disease, and questionnaires to evaluate quality of life. Safety will be monitored by tracking adverse events. The main outcome is the overall response rate assessed by an independent committee over three years. Participants health status and treatment effects will be closely observed during this extended period.
Actively Recruiting
Researchers are evaluating HS-20093, a fully humanized IgG1 antibody-drug conjugate that specifically targets B7-H3, a protein commonly found on solid tumor cells. This phase 2, open-label, multi-center study aims to assess the effectiveness, safety, how the body processes the drug, and immune response in patients with head and neck squamous cell carcinoma HNSCC and other solid tumors who have progressed on or cannot tolerate standard treatments. The study includes two parts Phase 2a with patients having recurrent or metastatic HNSCC or other advanced solid tumors, and Phase 2b with patients having recurrent or metastatic HNSCC. All participants will receive HS-20093 at a dose of 10 mgkg. Patients may continue receiving the treatment if it is well tolerated and provides ongoing clinical benefit. Safety will be monitored during treatment and for 90 days after the last dose. Participants will undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, blood tests to study drug levels and immune response, and monitoring for side effects. The main outcome is the objective response rate up to 24 months. Secondary outcomes include safety evaluations, drug concentration levels, duration of response, disease control, progression-free survival, and overall survival. The study follow-up lasts up to two years to fully capture treatment effects and safety.
Actively Recruiting
Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.
Actively Recruiting
Researchers are evaluating the safety, tolerability, and early effects of JS207 in adults with advanced non-small cell lung cancer NSCLC who have experienced disease progression after receiving platinum-based chemotherapy and immunotherapy. This phase II trial aims to assess how well JS207 works alone or combined with other treatments in this setting. Participants receive one of three treatments JS207 with docetaxel chemotherapy every three weeks, JS207 with JS004 antibody every three weeks, or JS207 alone at 10mgkg or another dose. These groups allow comparison of different combinations to explore potential benefits and safety profiles. During the study, participants will be monitored for tumor response, disease control, duration of response, progression-free survival, overall survival, and any adverse effects or laboratory abnormalities. These outcomes will be assessed over periods ranging from 1.5 to 2 years to gather comprehensive information about treatment effects and safety.
Actively Recruiting
Researchers are evaluating HS-20089, an investigational antibody-drug conjugate, in patients with recurrent or metastatic ovarian cancer and endometrial cancer. This phase 2, open-label, multi-center study aims to assess the drugs effectiveness, safety, how the body processes it, and its immune response. The study includes patients with different types of ovarian and endometrial cancers, some of whom have already undergone standard platinum-based chemotherapy treatments. The study has two parts phase 2a and phase 2b. In phase 2a, patients are divided into cohorts based on their cancer type and prior treatments. Some patients are randomly assigned to receive HS-20089 at doses of 4.8 mgkg or 5.8 mgkg every three weeks, while others receive 5.8 mgkg. In phase 2b, patients receive HS-20089 at a recommended dose determined by earlier research. Treatment continues until disease progression or other criteria for stopping treatment are met. Participants will have tumor assessments using RECIST 1.1 criteria at regular intervals to measure response to the treatment. Researchers will monitor safety by tracking side effects and immune reactions, and measure how the drug is processed in the body. The main outcome is the objective response rate over up to 24 months. Additional measurements include progression-free survival, overall survival, and disease control rate. Participants are followed from the first dose until disease progression or withdrawal from the study.
Actively Recruiting
Researchers are comparing two surgical methods for treating cancer in the hepatic flexure and proximal transverse colon Laparoscopic Ileocecal-Sparing Right Hemicolectomy LISH and traditional laparoscopic right hemicolectomy TRH. This prospective, multicenter, open-label, randomized clinical trial aims to evaluate long-term outcomes such as disease-free survival, overall survival, and quality of life after these surgeries. Participants are randomly assigned to either the LISH group, where a novel surgery preserving the ileocecal region is performed, or the TRH group, undergoing the standard right hemicolectomy. Both procedures involve precise dissection of lymph nodes and colon resection with different surgical techniques and anastomosis types. The study monitors outcomes over several years, including perioperative complications and colonoscopy findings of new polyps or adenomas. During the study, patients will be evaluated for surgical complications within 30 days, the quality of surgical specimens, and quality of life through specific rating scales over three years. Follow-up includes colonoscopies to detect new growths and monitoring of overall survival for up to five years. This extended monitoring helps researchers understand the long-term effects and benefits of the two surgical approaches.