Fullerton

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Researchers are evaluating the safety and effectiveness of a periodontal hydrogel wound dressing called Emanate Perio PODS in people with generalized stage III periodontitis. The study aims to see if this dressing helps the healing process better than no treatment after cleaning plaque and tartar from teeth. Periodontitis is considered a chronic wound where harmful bacteria can invade the gums, and this study focuses on healing after scaling and root planing (SRP). Participants in the treatment group will use the Emanate Perio PODS device twice daily for 30 minutes immediately after toothbrushing and interdental cleaning. This device physically protects the healing periodontal pocket from bacteria during the critical healing phase, which usually lasts 15 to 30 minutes. By four weeks after SRP, the gum tissue is expected to mature enough to stop treatment. The device is only used after oral hygiene when the tissue is vulnerable to mechanical forces, minimizing patient burden and aligning with regular twice-daily toothbrushing. During the study, participants will be assessed for periodontal wound healing by checking for the presence or absence of gum bleeding 60 days after non-surgical therapy. Researchers will monitor safety and wound healing effectiveness while participants follow study procedures and avoid certain oral hygiene products and devices. The study includes thorough periodontal evaluations and digital scans to track healing progress over time.

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.

Researchers are evaluating BMS-986500 as a treatment for people with advanced solid tumors and those with advanced breast cancer previously treated with CDK4/6 inhibitors. This phase 1 study aims to assess BMS-986500 alone and in combination with other therapies, focusing on its safety and tolerability in these patient groups. Participants will receive BMS-986500 either by itself or combined with palbociclib and fulvestrant at specified doses on designated days. The study includes a group with advanced solid tumors and a subgroup with CCNE1-amplified ovarian cancer for specific evaluation. Treatment schedules and doses are defined according to the study protocol. During the study, researchers will monitor participants for dose-limiting toxicities, adverse events, serious adverse events, treatment-related events leading to discontinuation, and those resulting in death, all assessed up to 28 days after the last dose. Participants will undergo disease evaluations and performance status assessments to track treatment effects and safety throughout the study period.

Researchers are evaluating the safety, pharmacokinetics, and anti-B-cell effects of FT819 in people aged 12 to 70 years with moderate-to-severe active B-cell mediated autoimmune diseases. These diseases include systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study is a phase 1 trial designed to explore FT819 both alone and with an auxiliary medicinal product in these conditions, starting with dose escalation followed by an expansion phase to further assess safety and activity. Participants will receive FT819 administered by intravenous infusion at planned dose levels. Additional drugs including fludarabine, cyclophosphamide, and bendamustine may also be given intravenously at specified doses. The study includes a dose-escalation stage to find safe dosage levels, then an expansion stage to gather more data on safety and biological activity of FT819 in the target diseases. During the trial, participants will be closely monitored for treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities over up to approximately two years. Researchers will evaluate safety and pharmacokinetics through regular assessments, including physical exams, laboratory tests, and clinical evaluations. Participants must comply with study procedures and provide consent. The total participation time includes the treatment and follow-up periods needed to assess the outcomes and safety of FT819.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and antitumor effects of TORL-4-500, an antibody drug conjugate, in patients with advanced or metastatic solid tumors, including hepatocellular carcinoma and adrenocortical carcinoma. This is a first-in-human, Phase 1 study focusing on patients with measurable disease and good performance status. Participants will receive doses of TORL-4-500, with the study aiming to determine the maximum tolerated dose over the first 28 days and recommend a phase 2 dose over a two-year period. The treatment involves monitoring for adverse events and assessing tolerability and pharmacokinetics of the investigational drug. During the study, patients will undergo regular evaluations including safety assessments, laboratory tests, and imaging as needed to measure disease status and monitor side effects. Researchers will track the incidence and severity of adverse events and serious adverse events for up to two years, ensuring close observation of patient health throughout the trial.

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 investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.