Bradford

Researchers are exploring new treatments for radiographic axial spondyloarthritis r-axSpA, a type of arthritis causing pain, stiffness, and swelling in the spine and pelvic joints. This study aims to find out if different doses of tulisokibart, a study medicine, can improve symptoms of r-axSpA better than a placebo. A placebo looks like the medicine but contains no active drug, helping researchers understand tulisokibarts effects. Participants will be randomly assigned to receive either a high, medium, or low dose of tulisokibart, or a placebo, all given by subcutaneous injection. The study includes a 16-week placebo-controlled period followed by a 124-week long-term extension, which has a 40-week main extension and an 84-week optional extension. Participants on low dose or placebo will be rerandomized at week 16 to medium or high doses of tulisokibart. During the study, participants will undergo regular assessments including symptom evaluations, physical function tests, and MRI scans at the start and week 16. Researchers will track response rates, changes in disease activity, pain levels, and quality of life measures. Safety will be monitored throughout, and the study lasts up to about 140 weeks. The main outcome is the percentage of participants achieving a significant improvement in symptoms at week 16.

Researchers are evaluating the effects of vipoglanstat on non-menstrual pelvic pain NMPP related to endometriosis in women aged 18 to 44 years. This Phase 2 trial aims to assess how well vipoglanstat works and its safety in treating moderate to severe pain caused by endometriosis. The study is sponsored by Gesynta Pharma AB and is designed as a randomized, double-blind, placebo-controlled trial.

Researchers are studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease CKD and high blood pressure hypertension. This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 bcg on heart and lung outcomes in people with chronic obstructive pulmonary disease COPD who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate GFF MDI 14.49.6 bcg. The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are observing the real-world use of the drug elafibranor in people with Primary Biliary Cholangitis PBC, a rare progressive liver disease where bile ducts are damaged. This damage can cause liver scarring and symptoms like itching and fatigue. The study aims to collect information on how effective, safe, and tolerable elafibranor is for PBC patients receiving ongoing treatment. Each participant will be part of the study for about 5 years. Participants will continue their treatment with elafibranor as prescribed by their doctors while researchers gather data without altering care. The study monitors participants over a 60-month period, collecting information during routine physician follow-up visits. There is no placebo or comparison group since this is an observational study focusing on real-world use of elafibranor. During the study, researchers will track treatment response at 6 months and follow liver function tests, symptom changes like itching and fatigue, quality of life, liver stiffness, and safety measures up to 5 years. They will also assess participant satisfaction and adherence to treatment. Data is collected during regular medical visits, making participation flexible and integrated with usual care.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia caused by Alzheimers. This Phase III study is designed as a multicenter, randomized, double-blind, placebo-controlled trial to better understand how trontinemab may impact cognitive and functional changes in this population. Participants will be randomly assigned to receive either intravenous IV trontinemab or an IV placebo. The treatment period lasts for 72 weeks, during which participants will receive regular infusions. This trial includes detailed monitoring of brain changes using PET scans, cerebrospinal fluid and blood biomarkers, and cognitive assessments. Throughout the study, participants will undergo multiple evaluations including cognitive tests such as the Clinical Dementia Rating Scale and MMSE, brain imaging scans for amyloid and tau, and safety monitoring for adverse events and immune responses. The study will also assess everyday functioning and collect data on biomarkers related to Alzheimers disease. Participation requires a study partner and involves visits over approximately 72 weeks.

Psoriatic arthritis PsA is a chronic inflammatory disease affecting the joints and skin in people with psoriasis. Researchers are evaluating how well the drug zasocitinib TAK-279 works in adults with active PsA, considering their prior experiences with specific treatments. This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study sponsored by Takeda, focusing on participants with or without previous biologic medicine use. Participants will be assigned to one of three groups one receiving zasocitinib Dose A, another receiving Dose B, both taken orally once daily for up to 52 weeks, and a third group receiving placebo orally once daily for 16 weeks followed by zasocitinib Dose A or Dose B from weeks 16 to 52. The study lasts up to 60 weeks, including the treatment period and follow-up. During the study, participants will undergo assessments to measure improvement in PsA symptoms, including joint tenderness and swelling, skin lesion severity, physical function, fatigue, and overall disease impact using recognized scales such as the American College of Rheumatology ACR responses and Psoriasis Area and Severity Index PASI. Safety and efficacy will be monitored throughout the 52-week treatment and at regular intervals.

Researchers are evaluating the effects and safety of efgartigimod given intravenously in adults with primary immune thrombocytopenia ITP, a condition where the immune system attacks platelets. This phase 3 clinical trial aims to determine how well efgartigimod controls platelet counts compared to a placebo during a 24-week double-blinded treatment period. The study is sponsored by argenx and includes follow-up periods to monitor ongoing effects and safety. Participants will be randomly assigned in a 21 ratio to receive either efgartigimod IV or placebo IV during the double-blinded treatment period. After this, all participants will receive efgartigimod IV during a first 52-week open-label treatment phase, followed by an optional second 52-week open-label phase. After completing these treatment periods, participants will have an approximately 8-week follow-up while off the study drug, with total study participation lasting up to 138 weeks. During the study, participants will have regular blood tests to measure platelet counts and assess disease control. Researchers will track the number of weeks participants maintain platelet counts above specified levels and monitor any bleeding events or adverse effects. Safety is closely observed throughout the trial, including antibody responses to the drug. Participants will have scheduled visits and assessments throughout treatment and follow-up to gather comprehensive data on efgartigimods impact.

Researchers are evaluating solrikitug, a biological treatment, in people with chronic obstructive pulmonary disease COPD to assess its safety, tolerability, and how the body processes and responds to the drug. This 12-week, randomized, double-blind, placebo-controlled Phase 2 study aims to understand the effects of two different doses of solrikitug compared to a placebo, all given alongside standard COPD treatments. The study will enroll about 171 participants diagnosed with COPD who have elevated blood eosinophil levels. Participants will be randomly assigned to receive either a high dose or low dose of solrikitug or a placebo, delivered by subcutaneous injection at the study sites over a 12-week treatment period. After the treatment phase, there will be a 16-week follow-up period to monitor longer-term effects and safety. The injections are given under medical supervision during scheduled visits. During the study, participants will undergo assessments including blood tests to measure eosinophil counts and lung function tests such as FEV1. Researchers will track adverse events and serious adverse events throughout the treatment and follow-up periods. The total participation time will be approximately 28 weeks, including treatment and post-treatment observation.

This research aims to assess the long-term safety and explore the effects of astegolimab in adults with chronic obstructive pulmonary disease COPD who have completed a 52-week treatment period in earlier studies named GB43311 or GB44332. The study is an open-label extension phase III trial sponsored by Hoffmann-La Roche, focusing on participants aged 40 to 90 years. Participants who qualify from the parent studies will receive astegolimab through subcutaneous injections every two weeks throughout the study duration. This open-label extension allows all participants to receive the active drug without placebo comparison. During the study, researchers will monitor participants for any adverse events up to 12 weeks after the last dose, focusing on the safety of astegolimab. Participants will be regularly assessed to track any side effects and overall health changes related to their COPD condition while on this treatment. The study began in June 2023 and will continue until July 2034, allowing for long-term observation.