Chandler

Researchers are evaluating the safety, how the body processes, and effects on body weight of the investigational drug CRB-913 in participants with obesity. This Phase 1b study includes two parts: Part 1 focuses on healthy adults to measure drug levels in the blood after a single dose, while Part 2 involves obese participants to assess safety and weight effects using different doses compared to placebo. Part 2 is blinded so that participants, doctors, and the sponsor do not know who receives the drug or placebo. In Part 1, healthy adults receive a single dose of CRB-913 tablets to study how much of the drug enters the bloodstream and how long it stays. In Part 2, obese participants take one of three doses of CRB-913 or placebo once daily for 12 weeks. After treatment ends, participants are monitored for 28 days. The study includes a randomized, double-blind, placebo-controlled design for Part 2. Participants will attend study visits for drug administration, safety assessments, and blood tests to measure drug levels and effects on body weight. Researchers will monitor for side effects and adverse events from the first dose through 28 days after final dosing. The total participation time includes the 12-week treatment period plus the 28-day follow-up phase to evaluate safety and drug behavior in the body.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

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 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.

This research aims to evaluate and compare the effectiveness and safety of a new artificial tear formulation called ABBV-444 with Refresh Optive Unit Dose in adults diagnosed with Dry Eye Disease (DED), a chronic condition caused by insufficient or poor-quality tear production. The study is a Phase 3, multicenter, double-masked, randomized trial involving around 250 adult participants across approximately 20 sites in the United States. Participants begin the study with a 7-day run-in period using REFRESH PLUS eye drops. Those who meet eligibility criteria are then randomly assigned to receive either ABBV-444 eye drops or REFRESH OPTIVE Unit Dose eye drops. Both groups will use their assigned treatment for a 90-day period. These are topical eye drop treatments administered regularly during the study. During the study, participants will attend multiple visits at the study sites for medical assessments and to complete questionnaires. Researchers will monitor changes in symptoms using the Ocular Surface Disease Index (OSDI) score from baseline to day 90 and track any adverse events. The study includes detailed eye tests such as tear breakup time and staining assessments to evaluate treatment effects and safety over the 90-day treatment period.

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.

Ovarian cancer is a serious health concern with the highest death rate among gynecological cancers. Currently, a definitive diagnosis can only be made after surgery, as reliable tests to distinguish cancerous from benign ovarian abnormalities before surgery are lacking. Cleo Diagnostics has developed a new blood test measuring five biomarkers to better differentiate between benign and malignant ovarian conditions, showing promising results compared to the standard CA125 test. The study is evaluating the Cleo Diagnostics (CleoDX) Ovarian Adnexal Mass Score Test System. This diagnostic test analyzes five substances in the blood to provide a score indicating the likelihood of cancer in patients with an ovarian mass who require surgery. The test aims to help doctors make more informed decisions about surgery and patient care by improving pre-surgical cancer risk assessments. Participants will provide blood samples for the CleoDX test before surgery. Researchers will analyze the results after completing patient recruitment and continue for up to 12 months or until August 2026. The main outcome measured is the calculation of the CleoDX adnexal mass score. The study focuses on improving patient outcomes by identifying those with malignant conditions who need specialist care.

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 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.