Farmington Hills

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 safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating the effectiveness and safety of Xeomin injections in preventing chronic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections given into muscles of the head and neck. Participants have chronic migraine diagnosed for at least 12 months and meet specific headache and migraine day criteria. The study aims to measure changes in monthly migraine days over time with Xeomin treatment. Participants will receive four treatments spaced about 12 weeks apart over a total study duration of 52 to 55 weeks. The treatments involve injections of either Xeomin or placebo solution prepared with sodium chloride. Visits occur approximately every 4 weeks, totaling 14 visits: the first, last, and four treatment visits are on-site, while the other eight visits are remote via phone or video call. During the study, participants will keep headache diaries to track migraine and headache days. Researchers will focus on the change in monthly migraine days from baseline to six months after the first injection. Safety and effectiveness are monitored throughout, with frequent assessments during both on-site and remote visits to ensure accurate tracking of migraine symptoms and any side effects.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing episodic migraine. This phase 3 clinical trial focuses on adults who experience episodic migraine, aiming to measure changes in the number of migraine days per month. Participants must have a diagnosis of episodic migraine for at least 12 months and meet specific headache frequency criteria. Participants will receive four treatments of either Xeomin or placebo injections into muscles of the head and neck, with treatments spaced about 12 weeks apart. The entire trial lasts approximately 52 to 55 weeks, beginning with a screening period of 4 to 5 weeks. There are about 14 visits in total, with the first, last, and four treatment visits conducted on-site, while the other visits are held remotely via phone or video. Throughout the study, participants will track their migraine days using a headache diary, and researchers will assess changes in monthly migraine frequency from baseline to six months after the first injection. Regular monitoring includes both in-person and remote assessments. The primary outcome focuses on the change in monthly migraine days between baseline and month six after treatment initiation.

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are conducting a Phase 1, first-in-human, open-label multicenter study to evaluate ALX2004, an antibody drug conjugate targeting EGFR, in participants with advanced or metastatic selected solid tumors. The study will enroll up to 170 patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC). The purpose is to find safe and effective dosing and assess treatment responses in these patients. The study includes Phase 1a dose finding, which has a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. Participants will receive ALX2004 through intravenous infusion. Dose escalation focuses on participants who have relapsed or progressed after prior anticancer therapy, while dose exploration and expansion involve specific tumor cohorts with defined prior therapy limits. The treatment aims to target EGFR using this novel drug conjugate. During the study, participants will be monitored for treatment emergent adverse events and dose-limiting toxicities up to 28 days and up to 2 years after the first dose. Investigators will assess overall response rates using standardized criteria. Screening, evaluations, and follow-ups will include clinical assessments to evaluate safety, tolerability, and treatment effects throughout the study duration.

Researchers are evaluating HMBD-501, a HER3-targeted antibody-drug conjugate, in patients with advanced-stage, relapsed, or refractory solid tumors that express HER3. This Phase 1/2, first-in-human, open-label clinical trial aims to assess the safety, tolerability, how the drug moves in the body, and early signs of effectiveness in cancers such as melanoma, non-small cell lung cancer, and breast cancer. The study is divided into two phases. Phase 1 involves gradually increasing doses of HMBD-501 given to groups of patients to find a safe and tolerable dose to use in Phase 2. In Phase 2, patients receive the recommended dose to evaluate the drug’s preliminary effectiveness. HMBD-501 is given as an infusion, and dosing schedules are determined from the Phase 1 results to guide treatment in Phase 2. Participants will have regular visits for treatment, safety monitoring, and assessments, including laboratory tests and scans. Researchers will track side effects throughout the study, which lasts about six months on average per participant. The main outcomes include the frequency of treatment-related side effects in Phase 1 and the tumor response rate to treatment in Phase 2. Participants must follow contraception rules during and after treatment to ensure safety.

Researchers are studying the effects of NEU-411 in men and women aged 40 to 80 years who have early Parkinson's Disease (PD) with increased activity in the LRRK2 pathway, identified through a genetic test. This Phase 2 trial aims to evaluate how well NEU-411 works and its safety in this specific group compared to a placebo. The study involves participants with clinically established or probable PD and focuses on those with LRRK2-driven PD. Participants will be randomly assigned to receive either NEU-411, a brain-penetrant oral drug that inhibits LRRK2 activity, or a matching placebo once daily for 52 weeks. After completing this treatment phase, participants will have a safety follow-up visit within two weeks. Those eligible may join an open-label extension to receive NEU-411 for an additional 26 weeks. During the study, researchers will monitor changes in a digital biomarker score using a Parkinson's Disease app from enrollment through 52 weeks, along with recording any treatment-emergent or serious adverse events until the study ends at 54 weeks. Assessments include genetic testing, clinical evaluations of PD status, safety monitoring, and tracking of side effects to understand the drug's effects and tolerability over time.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

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.