Danbury

Researchers are studying the effects of APL-3007 combined with SyfovrePegcetacoplan APL-2 in people aged 60 and older who have geographic atrophy caused by age-related macular degeneration. This Phase 2, randomized, placebo-controlled, and masked study aims to evaluate how well this combination works, its safety, tolerability, and how the drugs affect the body. The study is sponsored by Apellis Pharmaceuticals, Inc. and involves multiple medical centers. Participants will be randomly assigned to one of three groups two experimental groups receiving different doses or frequencies of APL-3007 with pegcetacoplan, and a placebo group receiving placebo injections along with pegcetacoplan. The treatments involve multiple doses over the study period. The study eye will be carefully selected based on vision and lesion characteristics to receive the assigned treatment. During the 12-month study, participants will undergo various assessments including AI-based imaging scans to measure changes in retinal pigment epithelium RPE lesions, photoreceptor degeneration, and visual acuity. Safety will be monitored through adverse event reporting and lab tests. Other measures include serum C3 levels and functional vision tests under different lighting conditions. Participants will adhere to the study visit schedule and complete all required evaluations to help researchers understand treatment effects and safety.

Researchers are evaluating the effectiveness, safety, and tolerability of oral icotrokinra in treating adults and adolescents with moderately to severely active ulcerative colitis UC, a chronic condition where the large intestine lining becomes inflamed and develops ulcers. This Phase 3 clinical trial aims to compare icotrokinra with a placebo to better understand its impact on UC symptoms and remission rates. Participants will be divided into study groups receiving either icotrokinra or a placebo orally each day starting from Week 0 of the induction phase. After 12 weeks, responses will be assessed and participants who respond to icotrokinra or placebo enter a maintenance phase lasting up to Week 40. Adolescents receive open-label icotrokinra throughout the study, with an option for a long-term extension after completing the maintenance phase. During the trial, participants will undergo regular evaluations including clinical response, endoscopic assessments, and symptom monitoring at key points such as Weeks 12 and 40. Researchers will track remission rates, symptom improvements, quality of life, and safety outcomes. The study involves both double-blind and open-label phases and continues until January 2032, with close monitoring to understand how participants respond over time.

Researchers are evaluating the combination of disitamab vedotin and tucatinib in people with advanced or metastatic breast or gastric cancers that express the HER2 protein. These solid tumors, which start in organs like the breast or stomach, tend to grow quickly or spread, making treatment challenging. This Phase 2 clinical trial aims to test how safe and effective this combination therapy is, particularly for tumors that have HER2, which helps cancer cells grow faster and spread more easily. The study includes several phases a dose escalation phase to find the best dose of disitamab vedotin combined with tucatinib, followed by a dose optimization phase to assess safety and effectiveness at selected doses. After these phases, an expansion phase will evaluate this combination in four groups of participants with different HER2 expression levels and cancer types. Disitamab vedotin is given intravenously, while tucatinib is taken orally twice daily at 300 mg. Participants receive the combination therapy according to their assigned study group. During the trial, participants will undergo regular assessments including scans and lab tests to monitor tumor response and safety. The study will track side effects, dose changes, and overall treatment effects over several years, with some evaluations extending up to five years after treatment. Researchers will measure outcomes such as tumor response rate, duration of response, disease control, progression-free survival, and overall survival. Safety monitoring includes checking for adverse events and laboratory abnormalities throughout the study period.

Researchers are evaluating how well icotrokinra works and how safe it is for people with moderately to severely active Crohns disease, a condition that causes long-term inflammation in the intestines. This study is a Phase 2b3 trial that aims to understand both the effectiveness and safety of icotrokinra in treating this condition. Participants will receive icotrokinra or a matching placebo orally every day during the induction period lasting up to 12 weeks. Those who respond to the treatment at Week 12 may continue with different dosing options of icotrokinra or placebo during a maintenance phase up to Week 40. Following this, eligible participants can join a long-term extension study to further monitor treatment effects. During the study, participants will undergo evaluations of their clinical response, remission, and endoscopic response at Weeks 12 and 40 using established disease activity scores. Researchers will monitor safety by tracking adverse events up to 4 weeks after the last dose. The study includes regular assessments through endoscopy, patient-reported outcomes, and laboratory tests to measure how the disease and treatment effects progress.

Researchers are evaluating the safety and effectiveness of a combination treatment using carboplatin and mirvetuximab soravtansine in adult women with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses folate receptor alpha FRb1. This single-arm Phase 2 study focuses on patients with stage III or IV disease who have measurable tumors and high FRb1 expression. The investigational drug mirvetuximab soravtansine is designed to target and kill cancer cells carrying this receptor. Participants will receive intravenous infusions of mirvetuximab soravtansine combined with carboplatin on the first day of each 21-day cycle. Bevacizumab may also be given based on the investigators decision. This treatment will continue for 6 to 9 cycles over the course of the study, which is expected to last approximately three years. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, and scans to monitor their response to treatment and any side effects. Researchers will evaluate tumor response through imaging and other measures over up to three years, also tracking disease control, progression-free survival, and symptom changes. Safety will be closely monitored throughout the study period.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

This research evaluates the use of oral anticoagulation OAC combined with background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation POAF after isolated coronary artery bypass graft CABG surgery. The study aims to assess how effectively this approach prevents thromboembolic events and its safety regarding 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 treatment groups an experimental arm receiving OAC either a vitamin K antagonist or a direct oral anticoagulant along with antiplatelet therapy, or a control arm receiving antiplatelet therapy alone. The anticoagulation treatment lasts 90 days, and patients in the control group who experience recurrent atrial fibrillation after 30 days may switch to OAC. Follow-up includes clinic visits at 90 days and phone calls at 30, 60, and 180 days. A digital health substudy involving a wearable heart monitor for 30 days post-discharge is also offered to some participants. During the study, researchers will monitor outcomes such as death, stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization, along with bleeding events at 90 days. Data collection includes medical record reviews, risk profiling, and use of anticoagulants and antiplatelets. Safety and effectiveness will be analyzed by comparing the two treatment strategies. Participation may last up to six months, with assessments conducted in person and by phone.

Researchers are evaluating the use of apixaban compared to aspirin to prevent stroke or death in patients who have had a recent intracerebral hemorrhage ICH and also have atrial fibrillation AF. This phase III randomized, double-blinded trial aims to determine if apixaban is superior in preventing any type of stroke or death, as well as if it leads to better functional recovery measured by the modified Rankin Scale. The study will enroll 700 patients and follow them for 12 to 36 months to assess these outcomes. Participants will be randomly assigned to receive either apixaban or aspirin. Apixaban dosing is typically 5 mg twice daily, with a reduced dose of 2.5 mg twice daily for those meeting specific criteria such as older age, lower body weight, or certain medication use. Aspirin is given once daily at a dose of 81 mg. The study includes a treatment period after recent ICH, with careful monitoring for safety and efficacy. During the study, participants will undergo regular assessments including evaluation of stroke occurrence, death, and changes in functional status using the modified Rankin Scale. Safety and adherence will be monitored throughout the follow-up period, which ranges from 12 months up to 3 years. The research team will collect data to understand the benefits and risks of apixaban versus aspirin in this patient population.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are studying the safety and effectiveness of Cardiac Contractility Modulation CCM therapy in people with heart failure who have a left ventricular ejection fraction LVEF between 40 and 70. This clinical trial includes two parts with separate scientific goals Part I focuses on functional capacity and health status, while Part II evaluates clinical outcomes. The study is randomized, quadruple-blind, and sham-controlled, involving subjects from about 225 sites worldwide. Participants will have an OPTIMIZER Smart Mini System implanted that delivers CCM therapy. They will be randomly assigned in a 21 ratio to either have CCM therapy turned ON continuously or to a sham group with CCM therapy turned OFF for the first 18 months. After 18 months, the sham group will also have CCM therapy turned ON. CCM therapy consists of seven one-hour sessions distributed evenly over each 24-hour period. The study includes follow-up through both parts, lasting up to several years. During the study, participants will undergo screening and baseline testing before implantation. Researchers will measure changes in walking distance over six minutes and health status by the Kansas City Cardiomyopathy Questionnaire after six months. Safety will be assessed by tracking device- or procedure-related complications for 12 months. Clinical outcomes including mortality, morbidity, and health status will be reviewed after 18 months. Participants will be monitored regularly for these outcomes throughout the study duration.