Ternopil

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Researchers are studying budoprutug, an investigational humanized antibody that targets CD19 cells, in adults aged 18 to 65 with active and seropositive systemic lupus erythematosus SLE who have not responded adequately to standard treatments. This Phase 1b open-label study focuses on assessing the safety and tolerability of budoprutug, as well as its behavior in the body and early signs of effectiveness. Participants will receive a single intravenous infusion of budoprutug at one of several ascending dose levels. The study will monitor how the drug affects B cell counts and antibody levels in the blood over time following the infusion. Multiple dose groups will be evaluated to understand safety and the drugs movement and action in the body. Throughout the study, participants will be closely observed for treatment-emergent adverse events and changes in vital signs and laboratory tests up to 24 weeks after dosing. Researchers will also measure budoprutugs concentration in the blood and immune responses, including the presence of anti-drug antibodies. The total monitoring period helps ensure comprehensive safety and pharmacological data collection.

Researchers are evaluating the safety and tolerability of three different dose regimens of budoprutug in adults with primary membranous nephropathy PMN who test positive for anti-PLA2R antibodies and continue to have proteinuria despite optimized RAAS inhibition. This Phase 2, open-label, multicenter study aims to assess the safety, pharmacodynamics, and early effectiveness of budoprutug, a humanized monoclonal antibody that targets CD19 to deplete specific cells through antibody-dependent cellular cytotoxicity. Participants will receive a single intravenous dose of budoprutug on Days 1, 15, 169, and 183 across three sequential dose groups. Approximately 45 subjects will be enrolled and treated with one of the three dose levels. The study includes an initial dosing period followed by extended follow-up to monitor B-cell recovery and other effects up to Week 48. During the study, participants will be closely monitored for adverse events and changes in various laboratory measures, including B cell counts, anti-PLA2R antibody levels, proteinuria, and kidney function. Researchers will evaluate safety outcomes up to Week 48 and assess pharmacokinetics such as plasma concentration and clearance. Follow-up visits will track participant health, treatment effects, and recovery over the course of the study.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating mavorixafor, a drug being studied for people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These conditions cause low neutrophil levels and lead to recurrent or serious infections. The study aims to show if mavorixafor can improve clinical outcomes and increase neutrophil counts, while also assessing its safety and tolerability. Participants will continue their current treatment during the study, which may include therapies like granulocyte-colony stimulating factor G-CSF, immunoglobulin replacement, antibiotics, or no active treatment. They will be randomly assigned to receive either mavorixafor or a placebo orally once daily for up to 52 weeks. The study uses a quadruple-blind design to compare these groups in parallel. During the trial, participants will have regular assessments to monitor infection rates and severity, neutrophil counts, antibiotic use, oral ulcers, and fatigue levels using questionnaires. An independent committee will review infections to ensure accuracy. Safety and treatment effects will be followed throughout the 52-week treatment period. The total participation may last until the study ends in late 2027.

Researchers are conducting a phase 3, open-label extension study to assess the long-term safety and tolerability of KarXT for treating mania or mania with mixed features in adults with Bipolar-I disorder. The study focuses on evaluating how participants respond to KarXT over an extended period, emphasizing safety measurements such as adverse events and symptom changes. Participants will receive KarXT at specified doses over a treatment period lasting up to 54 weeks. This study includes participants previously involved in related placebo-controlled studies as well as new participants diagnosed with Bipolar-I disorder with manic symptoms. The treatment may be given alongside standard therapeutic doses of lithium, valproate, or lamotrigine as applicable. Throughout the study, participants will undergo regular assessments including monitoring of treatment emergent adverse events, serious adverse events, and psychiatric symptom scales like the Columbia-Suicide Severity Rating Scale, Young Mania Rating Scale, and others. Safety and tolerability will be closely tracked, with evaluations occurring up to week 54. The entire participation may last until the study end date in June 2028, ensuring comprehensive long-term follow-up.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating the pharmacokinetics PK and safety of subcutaneous SC ublituximab in people with relapsing multiple sclerosis RMS. The study aims to compare how ublituximab is absorbed and tolerated when injected at different sites on the body and when administered using either a prefilled pen device or a syringe. This Phase 2 trial involves adult participants with RMS who meet specific neurological stability and disability criteria. Participants will receive ublituximab SC either by syringe at one of three injection sites or by randomized assignment to receive the drug with either a prefilled pen or a syringe. The study evaluates the relative bioavailability of ublituximab delivered by these two methods over a planned treatment period extending up to 120 weeks, with key assessments occurring up to 12 weeks and beyond. During the study, participants will undergo plasma concentration measurements of ublituximab at various time points to determine drug levels and steady state exposure. Safety will be monitored through tracking treatment-emergent adverse events throughout the study. Participant satisfaction with the SC administration method will also be assessed. This long-term study may involve multiple visits for drug administration, monitoring, and questionnaires, continuing for up to five years.