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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating how well JNJ-79635322 works compared with an anti-B-cell maturation antigen BCMAxCD3 bispecific antibody in adults with relapsed or refractory multiple myeloma. This phase 3 study includes participants who have received at least three prior therapies and have progressive disease or insufficient response to their last treatment. The study aims to assess treatment outcomes including overall response and progression-free survival over a period of up to 5 years and 7 months. Participants are randomly assigned to receive either JNJ-79635322 or teclistamab, both given as subcutaneous injections. Treatment continues until disease progression or intolerable side effects occur. These two groups allow comparison of the effects of each drug on disease control and patient well-being during the study. During the study, participants undergo regular assessments to monitor their response to treatment, including laboratory tests to measure disease markers and evaluations of symptoms, functioning, and quality of life. Researchers will track adverse events, immune responses to the drugs, and long-term outcomes such as duration of response and overall survival. The total participation time can extend up to nearly 6 years, with ongoing monitoring of symptoms and quality of life throughout this period.
Actively Recruiting
Researchers are evaluating mirikizumab for children and teenagers aged 2 to 17 years with moderately to severely active Crohns disease, including fistulizing Crohns disease with active inflammation in the colon or ileum. The study aims to assess the treatments effectiveness, safety, tolerability, and how well it is absorbed in the body. Participants must have a history of inadequate response or intolerance to other Crohns disease medications and will be randomly assigned to receive mirikizumab or another intervention. The treatment involves receiving mirikizumab either intravenously IV or subcutaneously SC, with dosing based on the participants weight in three different weight groups over 40 kg, 20 to 40 kg, and 9 to 20 kg. The study includes a 12-week induction period, followed by a maintenance phase lasting until Week 52. After treatment, there is a safety follow-up period lasting up to 16 weeks. The entire study spans about 74 weeks and may include up to 19 visits. Participants will undergo assessments including clinical response evaluations by the Pediatric Crohns Disease Activity Index PCDAI, endoscopic assessments using the Simple Endoscopic Score for Crohns Disease SES-CD, and laboratory tests such as C-reactive protein and fecal calprotectin levels. Pharmacokinetic studies will measure how the drug is cleared and distributed in the body. Safety monitoring continues during the follow-up period to track any adverse events or treatment tolerability throughout the study duration.
Actively Recruiting
Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease CKD and proteinuria, a condition where the kidneys leak protein into the urine. This study aims to evaluate the long-term safety of finerenone when added to standard treatments called ACE inhibitors or angiotensin receptor blockers ARBs, which are commonly used to control blood pressure and protect kidney function. The research also seeks to understand how well finerenone can reduce protein levels in urine and support kidney health over time. Participants will receive finerenone in doses adjusted by age and body weight, taken orally for up to 18 months alongside their usual ACEI or ARB treatment. The study includes patients who previously took part in a related trial and will follow them for about 19 months, including a one-month follow-up after treatment ends. The research involves one group receiving finerenone openly without placebo or comparison groups. During the study, participants will attend at least 8 to 12 visits depending on their treatment start status. At these visits, doctors will measure vital signs like blood pressure, heart rate, weight, and height perform physical exams collect blood and urine samples to monitor kidney function and protein levels and conduct heart tests using electrocardiograms and echocardiography. Participants and their caregivers will also answer questions about medication use, side effects, and overall well-being. Safety will be closely monitored by tracking any medical problems that arise during the trial.