Oxnard

Researchers are investigating the safety and effects of 4D-150 gene therapy in adults aged 50 and older with neovascular (wet) age-related macular degeneration (AMD) who are already receiving anti-VEGF treatment and have shown a clinical response. This Phase 1/2 trial includes dose-escalation and randomized, controlled, masked expansion phases, aiming to evaluate 4D-150 administered by intravitreal injection in one eye, with additional substudies assessing dosing in the second eye and vector shedding. Participants will receive a one-time dose of 4D-150 by injection into the study eye, followed by monthly assessments for 24 months to monitor safety and effectiveness. Those who receive 4D-150 will then enter a long-term follow-up period up to 5 years to assess ongoing safety and the duration of treatment effects. Substudies include one for contralateral eye dosing and another to characterize vector shedding, with participants monitored regularly for safety through one year and continuing long-term follow-up through year 5. Throughout the study, participants will undergo tests of visual and retinal function and structure, with assessments performed monthly initially and safety monitored for up to five years. Researchers will track treatment-emergent adverse events, serious adverse events, and any significant changes in safety parameters. Participants must comply with study procedures and visits, and males receiving 4D-150 will be advised to use barrier methods during intercourse for six months to prevent fluid transmission.

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.

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 the combination of PCS6422 with capecitabine compared to capecitabine alone in patients with advanced or metastatic breast cancer who are not eligible for certain therapies like anthracycline, taxane, PD-1, or PARP inhibitors. This adaptive Phase 2, open-label, randomized, multi-center study aims to assess the effectiveness and safety of this combination treatment in patients who have already received chemotherapy for metastatic breast cancer. Participants will receive either one of two regimens of PCS6422 combined with capecitabine or the standard dose of capecitabine alone. PCS6422 is an experimental drug that may enhance the immune response against cancer when combined with capecitabine, an oral chemotherapy drug commonly used in breast cancer treatment. Treatments will be given according to the assigned group, and the study is designed to adapt as it progresses. During the study, participants will be monitored for their tumor response up to 24 weeks after completing treatment and for any adverse events over an average of 8 months. Assessments include imaging to measure disease, laboratory tests to check organ function, and regular evaluations of overall health and side effects. The study focuses on measuring how well the cancer responds to treatment and the safety of the drug combination over the course of participation.

Researchers are evaluating the efficacy and safety of utidelone combined with capecitabine in patients who have HER2-negative breast cancer with brain metastases. This is a pivotal Phase II multicenter clinical trial that aims to assess both intracranial and systemic treatment effects in this patient population. The study focuses on comparing utidelone alone and utidelone with capecitabine to determine their impacts on brain metastases and overall disease control. Participants will receive utidelone intravenously once daily for five consecutive days every 21 days. In combination treatment groups, capecitabine is taken orally twice daily for days 1 to 14 of each 21-day cycle. Different dosing regimens of utidelone (25 or 30 mg/m2) combined with a fixed capecitabine dose (1000 mg/m2) are evaluated. Treatment cycles repeat every 21 days, and patients may receive multiple cycles as part of the study. During the study, participants will undergo regular assessments including brain MRI scans to measure intracranial tumor response according to RECIST 1.1 criteria over 12 months. Researchers will monitor safety, side effects, and systemic disease progression. Patients’ blood and organ function will be checked to ensure treatment tolerance. The main outcome is the intracranial objective response rate after treatment, with ongoing monitoring to evaluate both efficacy and safety throughout the study period.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the safety and side effects of LY4005130 in adults with non-segmental vitiligo (NSV). This Phase 2 study compares LY4005130 with a placebo to understand how well the drug is tolerated. Participants have NSV affecting certain areas of their body and face, with the condition being either active or stable for at least 3 months. Participants will receive LY4005130 or a placebo through an intravenous (IV) infusion into a vein in the arm. The treatment phase lasts 24 weeks, during which the effects and safety of the drug will be monitored. The entire study, including screening, will take about 48 weeks. Throughout the study, participants will undergo blood tests to assess how their body processes the drug and how the drug affects their body. Researchers will measure the percentage of participants achieving significant improvement in facial vitiligo after 24 weeks. Safety and side effects will be followed carefully during treatment and the study period.