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Found 18 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.
Actively Recruiting
This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.
Actively Recruiting
Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.
Actively Recruiting
Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.
Actively Recruiting
Researchers are evaluating LXE408 in adults with chronic Chagas disease without severe organ dysfunction. This study is a phase 2, randomized, participant- and investigator-blinded, controlled trial with four treatment groups. The goal is to assess the effectiveness, safety, tolerability, pharmacokinetics, and pharmacodynamics of LXE408 compared to placebo and benznidazole in clearing or reducing parasites in the blood. Participants are randomly assigned to one of four groups LXE408 taken orally for 28 days, LXE408 for 14 days followed by placebo for 14 days, placebo for 28 days, or benznidazole for 60 days. The study monitors parasite clearance using PCR tests at multiple time points, including early clearance at days 7, 14, and 28, and sustained clearance for up to 12 months. Pharmacokinetic measurements of LXE408 are also taken during treatment. Participants will undergo regular assessments including PCR testing for parasite levels at months 2, 4, 6, and 12, serology tests at months 6 and 12, and monitoring for adverse events up to 48 months. Safety evaluations and pharmacokinetic blood samples are collected during treatment. The total study duration extends up to 6 years including long-term follow-up to track treatment impact and participant health.
Actively Recruiting
Researchers are evaluating mavorixafor, a drug being studied for people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These conditions cause low neutrophil levels and lead to recurrent or serious infections. The study aims to show if mavorixafor can improve clinical outcomes and increase neutrophil counts, while also assessing its safety and tolerability. Participants will continue their current treatment during the study, which may include therapies like granulocyte-colony stimulating factor G-CSF, immunoglobulin replacement, antibiotics, or no active treatment. They will be randomly assigned to receive either mavorixafor or a placebo orally once daily for up to 52 weeks. The study uses a quadruple-blind design to compare these groups in parallel. During the trial, participants will have regular assessments to monitor infection rates and severity, neutrophil counts, antibiotic use, oral ulcers, and fatigue levels using questionnaires. An independent committee will review infections to ensure accuracy. Safety and treatment effects will be followed throughout the 52-week treatment period. The total participation may last until the study ends in late 2027.
Actively Recruiting
Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.
Actively Recruiting
Researchers are evaluating the medicine BI 3000202 for adults with systemic lupus erythematosus SLE, a condition involving immune system problems. The study is a phase 2 trial that tests different doses of BI 3000202 to find the best dose for people with moderate to severe SLE. Participants are randomly assigned to one of five groups, including four groups receiving different doses of the medicine and one group receiving a placebo, which looks like the medicine but has no active drug. Participants take their assigned tablets daily for one year while continuing their usual SLE treatments. The study groups include four different dose levels of BI 3000202 and a placebo group. During the study, participants regularly visit the study site for check-ups and monitoring. This careful schedule helps researchers watch for any effects or side effects of the treatment. Throughout the study, doctors assess participants health, monitor any unwanted effects, and compare outcomes between groups. The main measurement is whether participants achieve a response on the Systemic Lupus Erythematosus Responder Index SRI-4 at week 32. Additional measurements include responses at week 52 and disease activity scores. Participants stay involved for a bit longer than one year, with regular visits to the study site for health checks and to ensure their well-being.
Actively Recruiting
Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.
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