Thousand Oaks

Researchers are evaluating the GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System to assess its safety and effectiveness in treating adults with severe, symptomatic mitral regurgitation (MR). This prospective, multi-center, non-randomized clinical trial involves patients who have severe MR and suitable anatomy for device implantation and transfemoral trans-septal access. The study includes patients with primary MR at high surgical risk and those with secondary MR who have not responded to optimal medical therapy and other treatments. All participants will receive the investigational GeminiOne TEER device, which includes a clip implant made of cobalt-chromium-nickel alloy and a transcatheter delivery system. The trial is conducted at up to seven centers in the United States, Canada, and Europe. Initially, up to 15 subjects will be treated, with enrollment lasting about 12 months. After implantation, patients will be followed for 60 months to monitor long-term outcomes. Participants will undergo various assessments including transthoracic or transesophageal echocardiography reviewed by a core lab to confirm MR severity and anatomical suitability. Researchers will monitor safety by tracking any major device- or procedure-related adverse events within 30 days and evaluate acute procedural success. The total study duration is approximately 72 months, with ongoing evaluations to ensure patient safety and effectiveness of the device.

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.

This research aims to evaluate the safety and tolerability of ALD-102 Solution when injected into the scalp of adults with alopecia areata, a condition causing hair loss. The study also investigates the preliminary effects of ALD-102 on hair regrowth by comparing it to a placebo (saline solution without the drug) or an untreated area. Participants are selected based on specific scalp lesion characteristics and age, and the study is conducted as a Phase 1B/2A clinical trial to gather initial safety and efficacy data. Participants will receive injections of ALD-102 Solution or placebo once every four weeks over an eight-week treatment period. Treatment areas on the scalp will be chosen to receive either the drug, placebo, or no treatment, with the number of injections varying by study cohort (ranging from 20 to 40 injections). The study uses an intraindividual design where each participant has different areas treated differently for comparison. Throughout the 24-week combined treatment and follow-up period, researchers will assess participant safety by monitoring for treatment-related adverse effects and injection site reactions using clinical assessments and numerical scales. Hair regrowth and tolerability will also be evaluated. Participants are expected to comply with study procedures, including attending scheduled visits and enduring multiple intradermal injections, while researchers closely observe and measure outcomes related to safety and preliminary efficacy.

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.

This research aims to evaluate the effectiveness, safety, and tolerability of two doses of remibrutinib compared to placebo in people aged 12 years and older with moderate to severe hidradenitis suppurativa, a chronic skin condition. The study is a phase 3 clinical trial involving participants with a diagnosis lasting at least six months and active symptoms in multiple body areas. The purpose is to determine how well remibrutinib works and how safe and tolerable it is for this condition. The trial lasts a total of 76 weeks and includes several parts: a screening period of up to 4 weeks, a first treatment period of 16 weeks where participants receive either remibrutinib Dose A, Dose B, or placebo in a double-blind manner, followed by a second treatment period lasting 52 weeks during which all participants receive remibrutinib doses. After treatment, there is a 4-week safety follow-up without treatment. Participants stopping treatment early are encouraged to continue in the study and complete the safety follow-up. During the study, participants will be regularly monitored for their response to treatment, including the proportion who achieve a clinical response measure called HiSCR50 at Week 16. Assessments will include physical exams and safety checks throughout the treatment periods and follow-up. The study seeks to gather detailed information on how remibrutinib affects the severity of hidradenitis suppurativa and participants' overall health during and after treatment.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2b study to evaluate the safety and effectiveness of GIA632 in adults aged 18 years and older with non-segmental vitiligo (NSV). The study aims to find the best dose of GIA632 for further testing in a Phase 3 program. Participants must have a confirmed diagnosis of NSV with specific body surface area and Facial Vitiligo Area Scoring Index (F-VASI) scores. Participants will receive either GIA632 or a placebo during a 48-week core treatment period. This period is designed to establish the dose-response relationship and compare the effects of GIA632 with placebo. After this, there will be an extension phase to assess the longer-term safety and efficacy of the treatment. During the study, participants will be monitored for changes in their facial vitiligo through F-VASI scores from baseline to week 24. Researchers will also observe overall safety and treatment effects throughout the 48 weeks and the extension period. Participants will complete study-related questionnaires and follow study procedures to support the research assessments.

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 safety, systemic exposure, and potential effects on the hypothalamic-pituitary-adrenal (HPA) axis of a topical medication called IDP-122 lotion, which contains halobetasol propionate. This study focuses on children and teenagers aged 6 to 17 years with moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches. The study is a Phase 4, open-label trial aimed at understanding how the drug is absorbed and its impact on adrenal health in this pediatric population. Participants will apply IDP-122 lotion topically to areas affected by plaque psoriasis, excluding the face, scalp, underarms, and skin folds. The lotion is studied for its pharmacokinetics, including measuring the maximum concentration of the drug in plasma at various times after application. The study requires participants to avoid prolonged exposure to natural or artificial ultraviolet light during the treatment period. The trial does not include a placebo group and focuses solely on monitoring the topical treatment effects. During the study, children will undergo several evaluations including blood tests to measure drug levels in the plasma at multiple time points within 24 hours after dosing. Their adrenal function will be assessed through a stimulation test measuring serum cortisol. Researchers will also monitor the safety and any side effects related to the treatment. Participants will be carefully observed to ensure adherence to the treatment schedule and to track any changes in their psoriasis or overall health throughout the study period.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.