Cherry Hill Township

Researchers are studying the effects of APL-3007 combined with Syfovre/Pegcetacoplan (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 effects of azetukalner in adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode, also known as bipolar depression. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of azetukalner in this population. Participants must have had their first major depressive episode before age 50 and meet specific diagnostic criteria confirmed by clinical interview. Participants will be randomly assigned to receive either azetukalner 20 mg or a placebo orally once daily with food, preferably with the evening meal, for six weeks. The study has two groups: one receiving the experimental drug and one receiving a placebo, both taken over the same period. The study is designed to keep participants and researchers unaware of the group assignments to ensure unbiased results. Throughout the trial, participants will be evaluated using various measures, including changes in depression severity assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and at week 6, along with other scales at different time points. Safety and response will be monitored regularly during the six-week treatment period. The entire participation period is focused on this treatment phase, with assessments conducted to measure changes in symptoms and overall condition.

Researchers are evaluating azetukalner as a treatment for adults diagnosed with Moderate-to-Severe Major Depressive Disorder (MDD). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the clinical effectiveness, safety, and tolerability of azetukalner when used alone in adults aged 18 to 74 years who are currently experiencing a major depressive episode. The study is sponsored by Xenon Pharmaceuticals Inc. and focuses on improving depressive symptoms over a six-week period. Participants will be randomly assigned to receive either azetukalner 20 mg or a placebo once daily, taken orally with food, preferably with the evening meal. Treatment lasts for six weeks, during which the effects of the medication will be closely monitored. The study uses a quadruple-blind design, meaning that participants, care providers, investigators, and outcome assessors will not know which treatment is given to ensure unbiased results. During the study, participants will undergo regular assessments including the Hamilton Depression Rating Scale (HAMD-17) to measure changes in depression severity from baseline to Week 6, along with other scales like the Snaith-Hamilton Pleasure Scale (SHAPS) and Clinical Global Impression of Severity (CGI-S). Safety and tolerability will be monitored from about four weeks before treatment through eight weeks after the final dose. The total participation duration covers treatment and follow-up to evaluate both short-term effects and safety outcomes.

Researchers are evaluating the real-world experience of participants treated with BRIUMVI4 (ublituximab-xiiy) for relapsing multiple sclerosis (RMS). The study aims to assess the safety, effectiveness, and overall treatment experience of this medication in everyday clinical practice. The trial is observational, focusing on patients who have been prescribed BRIUMVI and tracking their outcomes over time. Participants in this study will receive BRIUMVI4 as an intravenous (IV) infusion specifically for RMS treatment. The study includes participants who have not previously received BRIUMVI infusions before the study begins, allowing observation from the start of their treatment. This approach helps understand how the medication performs outside of controlled clinical trial settings. During the study, researchers will monitor participants for up to 96 weeks, measuring the annualized relapse rate (ARR) to evaluate disease activity. They will also track adverse events, serious adverse events, and infusion-related reactions at each infusion visit. Participants will undergo regular assessments to capture their health status and any side effects, providing a comprehensive view of treatment safety and patient experience over nearly two years.

Researchers are studying the effects of experimental drugs called pozelimab and cemdisiran on people with Geographic Atrophy (GA), a late stage of Age-related Macular Degeneration (AMD) that affects central vision. The trial aims to compare the rate at which GA progresses in patients receiving cemdisiran alone, pozelimab combined with cemdisiran, or a placebo. The study also explores possible side effects, how much of the drugs remain in the blood over time, and whether the body develops antibodies that might impact treatment. Participants are randomly assigned to one of three groups: one receiving both pozelimab and cemdisiran, one receiving cemdisiran alone, and one receiving a placebo. All treatments are given by subcutaneous injection. The study is conducted in a double-masked manner to ensure unbiased results. Vaccinations against meningococcal and pneumococcal infections are required before participation. During the study, participants will attend regular clinic visits where eye imaging and vision tests will be performed to monitor the size of GA lesions and changes in visual acuity. Blood samples will be taken to measure drug levels and antibody development. The primary outcome is the growth rate of GA lesion area over 52 weeks. Safety will be monitored throughout and up to nearly six years. The overall study duration allows detailed assessment of treatment effects and tolerability.

Researchers are observing the real-world use of the drug elafibranor in people with Primary Biliary Cholangitis (PBC), a rare progressive liver disease where bile ducts are damaged. This damage can cause liver scarring and symptoms like itching and fatigue. The study aims to collect information on how effective, safe, and tolerable elafibranor is for PBC patients receiving ongoing treatment. Each participant will be part of the study for about 5 years. Participants will continue their treatment with elafibranor as prescribed by their doctors while researchers gather data without altering care. The study monitors participants over a 60-month period, collecting information during routine physician follow-up visits. There is no placebo or comparison group since this is an observational study focusing on real-world use of elafibranor. During the study, researchers will track treatment response at 6 months and follow liver function tests, symptom changes like itching and fatigue, quality of life, liver stiffness, and safety measures up to 5 years. They will also assess participant satisfaction and adherence to treatment. Data is collected during regular medical visits, making participation flexible and integrated with usual care.

Researchers are evaluating the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has a specific genetic mutation called PIK3CA. This phase 3 study aims to assess both the effectiveness and safety of this combination treatment. Participants can remain in the study as long as the treatment is helping control the cancer without causing unbearable side effects. Participants will receive Tersolisib orally in combination with an oral CDK4/6 inhibitor and endocrine therapy (ET), which may be given orally or by intramuscular injection. The study includes different groups: one receiving two different doses of Tersolisib plus CDK4/6 inhibitor and ET, another receiving one dose of Tersolisib plus CDK4/6 inhibitor and ET, and a placebo group receiving placebo with CDK4/6 inhibitor and ET. The CDK4/6 inhibitors used include ribociclib, palbociclib, or abemaciclib, while ET options include anastrozole, letrozole, exemestane, or fulvestrant. During the study, participants will undergo evaluations that include measuring tumor response, progression-free survival, overall survival, and quality of life using questionnaires. Researchers will monitor participants regularly through scans, lab tests, and clinical assessments to track treatment response and side effects. The study may last up to 7 years to observe long-term outcomes, and participants will be closely followed to assess how the cancer responds and how the treatments affect their health and well-being over time.

Researchers are evaluating the effectiveness of AXS-05 compared to bupropion in preventing the return of depressive symptoms in adults with major depressive disorder (MDD) who have already responded to treatment with AXS-05. This is a randomized, double-blind, active-controlled study conducted across multiple centers, aiming to assess relapse prevention in people diagnosed with MDD without psychotic features. Participants will first receive open-label AXS-05 treatment for up to 10 weeks, during which their response and remission will be monitored. Those who meet response and remission criteria will then be randomly assigned to continue taking AXS-05 or switch to bupropion tablets, both taken twice daily, for a double-blind treatment period lasting up to 26 weeks or until depressive symptoms relapse. Throughout the study, participants will be closely monitored for signs of depressive symptom relapse using regular assessments. The main outcome measured is the time from randomization to relapse over the 26-week double-blind period. The entire study period includes an initial 10-week treatment phase followed by up to 26 weeks of randomized treatment, with ongoing evaluation by the study team to track safety and treatment effects.

Researchers are studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase II/III trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.

Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder (PTSD). This Phase 3 clinical trial aims to compare two different doses of TSND-201 against a placebo to better understand its impact on PTSD symptoms. Participants must have had PTSD symptoms for at least six months and have tried at least one previous treatment. Participants will be randomly assigned to one of three groups: one receiving TSND-201 at Dose Level 1, another receiving TSND-201 at Dose Level 2, and the third receiving a placebo. Each participant will take capsules orally once a week for four consecutive weeks during the Treatment Period. After this, they will enter an 8-week Follow-up Period where no study drug is given, but their condition will continue to be monitored. During the study, participants will undergo regular assessments including the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) to measure changes in PTSD symptom severity up to 12 weeks. The study includes careful safety monitoring and requires participants to communicate well enough to complete interviews and questionnaires. The total duration of participation covers the 4-week treatment plus the 8-week follow-up, allowing researchers to observe both immediate and lasting effects of the treatment.