Westlake Village

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 evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are studying the safety and performance of Motiva Implants®, silicone gel-filled breast implants used for breast augmentation and revision procedures. This prospective, non-randomized, multicenter study collects data before surgery, during the operation, and annually for up to 10 years. The study also compares the incidence of connective tissue disease signs and symptoms in participants with Motiva implants to a control group undergoing other aesthetic surgeries. Participants receive either Motiva Implants® during breast augmentation or revision surgeries or undergo other aesthetic procedures like liposuction, rhinoplasty, or face-lifts in the control group. The study includes monitoring of implant performance and safety, with some participants possibly undergoing CT, ultrasound, or MRI evaluations if recommended. Participants agree to return explanted devices to the sponsor, and they must follow all study requirements throughout the study period. During the 10 years of follow-up, participants have yearly assessments to gather operative and postoperative data. Researchers evaluate safety and effectiveness, tracking any signs of connective tissue diseases and other outcomes related to the implants or aesthetic procedures. The study monitors participant health and implant status through imaging and clinical evaluations to provide long-term safety information.

Researchers are studying the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus who test positive for anti-nuclear antibodies. This extension study involves participants who previously completed treatment in one of two core SIRIUS-SLE studies. The aim is to monitor how well ianalumab is tolerated over an extended period compared to a placebo. The study compares monthly or quarterly subcutaneous injections of ianalumab to monthly placebo injections. Participants receive these treatments after completing the initial core studies (CVAY736F12301 or CVAY736F12302). This extension phase focuses on continued monitoring of these treatments over a long time frame. Participants will be observed for treatment-emergent adverse events and serious adverse events for up to approximately 91 months. Assessments include monitoring safety and tolerability throughout the study period. The total participation duration depends on individual study completion, with ongoing evaluation to ensure participant well-being during this extended follow-up.

Researchers are evaluating the safety and effectiveness of a drug called PF-07220060 combined with letrozole compared to other approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole) in adults with breast cancer that is hormone receptor-positive and HER2-negative. This cancer has spread locally or to other parts of the body and has not been treated with systemic anti-cancer therapy for advanced or metastatic disease. The study is a Phase 3, open-label, randomized trial involving multiple centers. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or the investigator's choice of one of the approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) combined with letrozole. The treatments are given as drugs with letrozole serving as endocrine therapy. The study compares these treatments in terms of how well they control the cancer and their safety profiles. Participants will visit the study clinic regularly for monitoring during treatment. Researchers will assess how long participants live without their disease worsening or dying from any cause, which is the main outcome measured up to about four years. The study team will monitor each participant's health and response to treatment through these visits to gather information about treatment effects and safety.

Researchers are evaluating whether combining the investigational drug mevrometostat (PF-06821497) with enzalutamide works better than enzalutamide alone in men with metastatic castration-sensitive prostate cancer (mCSPC) who have not previously received androgen receptor pathway inhibitors or chemotherapy in this setting. This Phase 3, randomized, double-blind, placebo-controlled study involves participants who have only received limited prior androgen-deprivation therapy and no evidence of disease progression before starting the study. Participants will be randomly assigned to one of two groups: one group receives oral mevrometostat together with oral enzalutamide continuously, while the other group receives a placebo with oral enzalutamide continuously. The study includes a Screening Phase, a Treatment Phase after randomization, followed by Safety Follow-up and Long-Term Follow-up periods to monitor outcomes and side effects. Throughout the study, participants will undergo regular assessments including imaging scans to evaluate disease progression, laboratory tests, and monitoring of symptoms and adverse events. The main outcome measured is Radiographic Progression Free Survival (rPFS) over approximately 4 years from randomization. Safety and long-term effects will also be monitored to understand how well participants tolerate the treatments and how the disease responds over time.

Researchers are evaluating the safety and effectiveness of MANP (modified atrial natriuretic peptide) given by subcutaneous injection to reduce daytime systolic blood pressure in adults with difficult to control or resistant hypertension. This Phase 2 study compares MANP to a placebo in participants who are taking three or more antihypertensive medications with different mechanisms of action. The study focuses on people aged 18 to 80 years who have high blood pressure despite treatment. Participants will receive daily injections of either MANP or a placebo for 42 days. This dose-titration study monitors the response to the treatment over this period. The placebo used is a matched vehicle without the active ingredient. The study aims to observe changes in blood pressure and evaluate potential side effects during and after treatment. During the study, participants will have their blood pressure measured using 24-hour ambulatory blood pressure monitoring to assess changes from baseline. Researchers will also monitor and record any adverse events, serious adverse events, and treatment-emergent adverse events for up to four weeks after the treatment ends, which totals approximately 10 weeks of follow-up. These assessments help determine the safety and efficacy of MANP in this population.