Cherry Hill Township

Researchers are exploring new treatment options for neovascular age-related macular degeneration NVAMD, a condition affecting the eyes. This trial aims to compare a new medicine called tiespectus also known as MK-8748 or EYE201 with the standard treatment aflibercept to see if tiespectus works as well in treating NVAMD. The study includes adults aged 50 and older who have not previously received treatment for this condition. Participants will be randomly assigned to one of three groups tiespectus low dose, tiespectus high dose, or aflibercept. Those in the tiespectus groups will receive three initial injections every 4 weeks, followed by injections every 8 weeks up to week 48. After week 48, treatment will continue at intervals based on individual response until week 92. The aflibercept group will receive three initial injections followed by injections every 8 weeks until week 92. During the study, participants will have their vision tested using the Best-Corrected Visual Acuity BCVA score and their eye structure examined with imaging techniques. Researchers will monitor changes in vision over one year and track any side effects up to approximately 96 weeks. Participants will attend regular visits for treatment and assessments throughout the study period lasting about 92 weeks.

Researchers are investigating the effects of APL-3007 combined with SyfovrePegcetacoplan APL-2 in patients with geographic atrophy caused by age-related macular degeneration AMD. This Phase 2 randomized, placebo-controlled study aims to assess the efficacy, safety, tolerability, and pharmacodynamics of these treatments in this eye condition. The study involves multiple centers and uses a masked design to ensure unbiased results. Participants will be assigned to one of three groups two receiving different doses or frequencies of APL-3007 in combination with pegcetacoplan APL-2, and one receiving a placebo along with pegcetacoplan APL-2. The study will evaluate the treatments given as multidose regimens. The treatments focus on complement C3 inhibition to potentially impact disease progression. Throughout the study, participants will undergo assessments including artificial intelligence-based imaging to measure retinal pigment epithelium lesion area and photoreceptor degeneration, safety evaluations through adverse event reporting and visual acuity tests, and blood tests to assess serum markers. These evaluations occur over 12 months to monitor changes from baseline. Participants involvement includes regular visits for these assessments, with the study tracking treatment effects and safety over the duration.

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-sberg 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 efficacy, safety, and tolerability of azetukalner when taken alone. The study involves participants aged 18 to 74 who have experienced their first major depressive episode before age 50. Participants receive either azetukalner 20 mg or a placebo orally once a day with food, preferably with the evening meal, for a total of 6 weeks. The study includes two groups one taking azetukalner and the other taking placebo, both under blinded conditions to ensure unbiased results. During the study, participants will be regularly monitored through clinical evaluations, including changes in depression severity scores such as the Hamilton Depression Rating Scale HAMD-17 and other scales measuring pleasure and clinical global impression. Safety and tolerability will be observed from screening through 8 weeks after the final dose. The total study duration includes screening, 6 weeks of treatment, and post-treatment safety follow-up.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are observing the use of the drug elafibranor in people with Primary Biliary Cholangitis PBC, a rare progressive liver disease that damages bile ducts and can lead to liver scarring. The study aims to collect real-world information on how effective, safe, and tolerable elafibranor is for participants receiving this treatment. The total participation lasts about 5 years for each person. Participants in the study are those who have been diagnosed with PBC and are either starting or currently receiving treatment with the commercialized drug elafibranor. The study does not intervene with treatment but monitors participants as they use the drug in routine care. Data is collected during regular physician follow-up visits over the 60-month period. During the study, researchers will assess response to treatment at 6 months and continue monitoring various health measures such as liver function tests, symptom scales for itching and fatigue, quality of life questionnaires, and liver stiffness. They will also track adverse events, treatment satisfaction, and adherence throughout the study. Follow-up is based on routine medical visits, with no extra visits required specifically for the study.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

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 investigating treatments for muscle-invasive bladder cancer, a type of bladder cancer that spreads into the muscle wall. Standard care involves chemotherapy followed by surgery to remove the bladder, which can have significant long-term effects. This study focuses on people who can have surgery but aims to find new options that might allow them to keep their bladder, especially for those responding well to the combination of enfortumab vedotin and pembrolizumab. Participants will receive infusions of enfortumab vedotin on the 1st and 8th days of each 21-day cycle, along with pembrolizumab on the 1st day of each cycle. Treatment continues unless the cancer worsens, does not improve after 9 cycles, or other medical reasons arise. If cancer progresses or does not respond, participants may require surgery, radiotherapy, or chemotherapy. The study includes ongoing safety checks and tumor assessments during treatment. During the study, participants will have regular clinic visits for treatment and safety monitoring. After stopping treatment, they will have health checks and scans every 12 weeks for up to 2 years, then every 24 weeks for up to 5 years if cancer remains stable. If cancer worsens, scans stop, but health checks continue by phone every 3 months. Researchers will measure response rates and bladder preservation over time, along with survival and safety outcomes.