Danbury

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating a combination of disitamab vedotin and tucatinib for treating patients with advanced or metastatic breast cancer or gastric cancer that express the HER2 protein. These solid tumors, which arise in organs like the breast or stomach, are challenging to treat once they have spread or grown larger. The trial focuses on patients whose tumors have HER2, a marker that can make the cancer grow and spread faster. The study aims to assess the safety and effectiveness of this drug combination in these cancers. The study includes a dose escalation phase where disitamab vedotin is given intravenously while tucatinib is taken orally twice daily at 300 mg. After determining two appropriate dose levels, the study proceeds to a dose optimization phase to evaluate safety and efficacy in different patient groups based on HER2 expression and cancer type. Following this, an expansion phase will test the treatment in four specific cohorts, including HER2-low and HER2-positive breast and gastric cancers. Participants will have regular assessments including monitoring for side effects, laboratory tests, and scans to evaluate tumor response using RECIST criteria. Safety will be followed for up to approximately five years after the last treatment dose. Key outcomes measured include the number of participants experiencing dose-limiting toxicities, adverse events, laboratory abnormalities, and dose changes. The study also tracks the objective response rate to the treatment over about three years.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the safety and effectiveness of neoadjuvant carboplatin combined with mirvetuximab soravtansine in adult women with folate receptor alpha (FRα)-expressing advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This is a single-arm Phase 2 study involving about 140 participants across approximately 80 sites in the United States. The study focuses on advanced disease stages III and IV, with FRα expression confirmed in tumor cells. Participants will receive intravenous infusions of mirvetuximab soravtansine together with carboplatin on day 1 of each 21-day cycle, continuing for up to 6 to 9 cycles. Bevacizumab may also be given as an intravenous infusion if the investigator decides it is appropriate. The total duration of the study is about 3 years, during which treatments and responses will be closely monitored. During the study, participants will attend regular visits at hospitals or clinics for medical evaluations including blood tests, scans, and safety assessments. Researchers will track tumor response using independent central review over the course of up to 3 years. The study involves frequent medical monitoring to assess treatment effects and participant safety.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are evaluating the safety and effectiveness of AGN-193408 SR in people with open-angle glaucoma or ocular hypertension. This Phase 1/2 study includes different study designs such as an initial open-label dose escalation and later randomized, masked, parallel groups to compare treatments. The study focuses on participants with these eye conditions and aims to measure changes in intraocular pressure and monitor any treatment-related side effects over 36 months. The study uses an implant called AGN-193408 SR, which contains a preservative-free drug dispersed in a biodegradable polymer. The implant is inserted into the front chamber of the study eye using a preloaded applicator. Comparator treatments include topical eye drops of Lumigan 0.01% in the fellow eye and sham administrations using a needleless applicator that simulates the implant procedure. Vehicle eye drops are used for masking in certain cohorts. Treatment schedules vary by cohort, with daily evening eye drops starting from Day 1 in some groups. Participants will be involved in regular assessments to track intraocular pressure changes and any adverse events from baseline up to 36 months. Evaluations include eye exams, monitoring for side effects, and adherence to treatment protocols. Researchers will measure the main outcomes by comparing intraocular pressure at hour 0 from baseline to 36 months and counting participants who experience treatment emergent adverse events during this time frame. The study includes safety follow-up and long-term monitoring throughout the 3-year period.

Researchers are evaluating the effectiveness and safety of adding oral anticoagulation (OAC) to standard antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. This phase 3, multicenter, open-label, randomized trial aims to compare the prevention of thromboembolic events like stroke or heart attack against the risk of major bleeding. Patients who decline randomization may join a parallel registry to capture their treatment choices and risk profiles. Participants will be randomly assigned to one of two groups: the OAC-based strategy group receiving oral anticoagulants such as vitamin K antagonists or direct oral anticoagulants combined with antiplatelet therapy, or the control group receiving antiplatelet therapy alone with aspirin or a P2Y12-inhibitor. The anticoagulation treatment is given for 90 days, with the possibility for patients in the control arm who develop recurrent atrial fibrillation after 30 days to switch to anticoagulation. The study follow-up includes visits at 90 days and phone calls at 30, 60, and 180 days. Up to 500 patients may participate in a digital health substudy using a wearable heart rhythm monitor for 30 days after discharge. During the study, researchers will monitor participants for serious events such as death, ischemic stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization. Safety is assessed by tracking major bleeding events up to 90 days. Data from the registry group will be analyzed to compare risk profiles and treatment strategies. Participants will be evaluated through clinical visits, phone follow-ups, medical record reviews, and in some cases, digital monitoring to understand treatment effects and safety over time.

Researchers are evaluating the safety and effectiveness of apixaban compared with aspirin in patients who recently had an intracerebral hemorrhage (ICH) and also have atrial fibrillation (AF). The study aims to find out if apixaban is better than aspirin in preventing any type of stroke or death from any cause. It also looks at whether apixaban leads to better functional recovery measured by the modified Rankin Scale. This is a phase III, randomized, double-blinded trial enrolling 700 patients over 3.5 years. Participants will be randomly assigned to receive either apixaban, an oral blood thinner that inhibits Factor Xa, or aspirin, an oral antiplatelet medication. The study lasts from 12 months up to 36 months of follow-up after enrollment. Treatments are given orally, and patients will be monitored throughout the study period. Recruitment and coordination occur through NIH/NINDS StrokeNet sites. During the study, participants will undergo assessments including brain imaging (CT or MRI) to confirm diagnosis, functional outcome measurements using the modified Rankin Scale, and monitoring for any strokes or death. Safety will be closely observed, and patients will provide informed consent before joining. The primary outcome measured is stroke or death up to 3 years, and secondary outcomes include functional status changes. Participants are followed regularly to track these outcomes and overall health status.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.