Walnut Creek

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating a new treatment for adults aged 18 to 65 who have Social Anxiety Disorder triggered by public speaking. This Phase 2 clinical trial in the U.S. aims to study the effects, safety, and tolerability of repeated doses of Fasedienol Nasal Spray given intranasally. The study focuses on how well this treatment relieves acute anxiety symptoms caused by a public speaking challenge in a controlled clinical environment. Those who complete the initial study may also join an open-label extension to assess long-term safety and tolerability when using the nasal spray as needed for up to 12 months. Participants will be assigned to one of three groups receiving nasal spray doses 20 minutes before their public speaking challenge. One group gets two doses of Fasedienol Nasal Spray spaced 10 minutes apart, another group gets one dose of Fasedienol followed by a placebo dose, and the last group receives two placebo doses. The study compares these dosing schedules to see which best relieves anxiety symptoms. In the extension phase, eligible participants can use 3.2 micrograms of Fasedienol Nasal Spray up to six times daily for a year to monitor longer-term effects. During the study, participants will undergo clinical evaluations including anxiety rating scales and distress measurements before and after treatment. Researchers will assess responses to the public speaking challenge and monitor safety through physical exams and laboratory tests. The main outcome measured is the Subjective Units of Distress Scale over seven days between visits. Safety, tolerability, and symptom relief will be closely tracked throughout both the initial and extension phases, which together may last up to 12 months for some participants.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

This research aims to establish a Phase-2 master protocol framework to evaluate the safety and effectiveness of various investigational treatments for chronic weight management in adults with obesity or overweight. The study sets common entry criteria for participants across multiple specific intervention groups, called intervention-specific appendices (ISAs), which may begin independently as new treatments become available for clinical testing. The overall results will be reported after all ISAs are completed. The study involves multiple investigational drugs administered either by injection (subcutaneously) or orally. These include LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226, and placebo treatments matching the administration methods of the active drugs. Each ISA will detail the specific intervention procedures. Treatments are given according to the ISA schedules as participants are assigned to different groups. Participants will be involved from screening through treatment and monitoring phases, where their body weight stability and other health parameters are assessed. Researchers will track the number of participants allocated to each ISA during the first six weeks. Safety and efficacy will be evaluated throughout the study, which includes regular assessments and adherence monitoring. The study includes adults aged 18 to 75 with specific body mass index (BMI) criteria and weight stability prior to enrollment.

Age-related macular degeneration (AMD) is a common condition affecting many older adults, leading to Geographic Atrophy (GA) in the retina where light-sensitive cells are lost. This damage begins away from the central vision area called the fovea, but as GA grows and reaches the fovea, sharp vision is greatly reduced. The eDREAM study aims to evaluate if GAL-101 eye drops can slow the growth of GA and prevent it from affecting central vision. This is a Phase 2, double-masked, randomized study comparing GAL-101 to placebo drops in people with non-foveal GA caused by non-neovascular AMD. Participants will be randomly assigned to receive either GAL-101 or placebo eye drops. During clinic visits, patients will receive three drops spaced 5 minutes apart under supervision, and at home they will administer two drops once daily at 5-minute intervals. The treatment period lasts 12 to 24 months, with all patients participating for at least 12 months. Study visits include screening, baseline, and regular follow-ups at 1, 3, 6, 9, and 12 months, then every 3 months until the last patient completes 12 months of treatment. Participants will undergo detailed eye imaging and vision tests to monitor the size and progression of GA lesions and their vision quality. Safety and efficacy will be assessed through these visits and phone calls. The main outcome is how well GAL-101 slows the growth of GA lesions from baseline to up to 96 weeks. Patients' ability to administer the drops and adhere to the schedule will also be supported and monitored throughout the study.

Researchers are studying the effects of zelquistinel, a drug being evaluated for treating major depressive disorder (MDD) in adults aged 18 to 64 years. This Phase 2 clinical trial aims to find out if zelquistinel can reduce depression symptoms compared to a placebo and to assess its safety. Participants diagnosed with MDD and meeting specific severity criteria will be enrolled to better understand the drug's impact on depression scores and potential side effects. Participants will be randomly assigned to receive either zelquistinel or a placebo tablet once a week for six weeks. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug. The trial includes up to 28 days of screening, a 42-day treatment period with weekly clinic visits, and a 4-week follow-up phase. During visits, depression severity is measured using the Hamilton Depression Rating Scale-17 (HDRS-17). Throughout the study, participants will attend weekly clinic visits for depression assessments and monitoring of adverse events. Researchers will track changes in depression scores from baseline to six weeks to evaluate effectiveness. Safety evaluations and follow-up assessments continue for four weeks after treatment. The total participation time may last up to 98 days, including screening, treatment, and follow-up.

Researchers are evaluating the effectiveness, safety, tolerability, and pharmacodynamics of multiple doses of APL-3007 combined with Syfovre/Pegcetacoplan (APL-2) in patients aged 60 years and older diagnosed with geographic atrophy secondary to age-related macular degeneration. This Phase 2, randomized, placebo-controlled, multicenter, masked study focuses on measuring changes in retinal pigment epithelium lesions using advanced artificial intelligence-based SD-OCT imaging. Participants will receive either the combination of APL-3007 with pegcetacoplan (APL-2) or a placebo. The study includes a treatment period with multiple doses administered, aiming to assess the impact on geographic atrophy lesions over a 12-month period. Syfovre injections at 6-8 week intervals prior to enrollment are part of the inclusion criteria. During the study, participants will undergo various eye imaging assessments such as OCT and FAF to monitor lesion size and progression. Researchers will evaluate changes in lesions at month 12 compared to baseline. Safety and tolerability will be closely monitored through laboratory tests, clinical evaluations, and vaccination status requirements. The study duration includes regular visits for treatment administration and monitoring over at least one year.

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.