Duncansville

Researchers are evaluating the safety and effectiveness of the drug LY4065967 for treating diabetic peripheral neuropathic pain (DPNP). This study is part of a larger chronic pain master protocol aimed at speeding up the development of new treatments for chronic pain. Participants have diabetic peripheral neuropathy mainly affecting their lower limbs and have had this condition for at least six months. The study compares oral LY4065967 to a placebo, with participants randomly assigned to either group. The trial is a Phase 2, randomized, placebo-controlled clinical trial. Treatments are given by mouth, and participants continue their usual diabetes care with stable treatment for at least 90 days before screening. During the study, researchers monitor changes in average pain intensity using a numeric rating scale from baseline to week 8. Participants undergo assessments including blood sugar control (HbA1c), body mass index measurement, and safety monitoring for heart and vitamin B12 status. The trial is designed for adults aged 18 years and older and includes close observation to ensure participant safety throughout the study period.

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 investigating new treatments for rheumatoid arthritis (RA), a condition where current therapies like methotrexate (MTX) may not fully control symptoms for many people. This Phase 2b study evaluates a medicine called tulisokibart to see if it can better reduce RA symptoms in individuals already taking MTX. The trial aims to determine if one or more doses of tulisokibart work better than a placebo, which looks like the medicine but contains no active drug. The study includes a 12-week period where participants receive either tulisokibart or a placebo by subcutaneous injection while continuing their MTX treatment, which can be given by injection or orally. Following this, there is a long-term extension lasting 116 weeks, composed of a 44-week main extension and a 72-week optional extension, to further assess the medication's effects and safety over time. Participants will undergo assessments to measure treatment response, including the American College of Rheumatology 20% response criteria at week 12 to gauge symptom improvement. Throughout the study, researchers will monitor for safety and effectiveness, with evaluations extending through the long-term extension periods, totaling over two years of participation.

Researchers are evaluating the safety and effectiveness of oral AP1189 combined with methotrexate (MTX) in adults with early rheumatoid arthritis (RA) who have not previously taken disease-modifying anti-rheumatic drugs (DMARDs). This phase II, randomized, double-blind, placebo-controlled study aims to understand how different doses of AP1189 affect disease activity and inflammation in participants with active RA symptoms. The study involves four groups of 60 participants each, receiving either AP1189 at doses of 40 mg, 70 mg, 100 mg, or a placebo, all alongside oral methotrexate. Treatments are given daily for 12 weeks. Participants will be randomly assigned to one of these groups to compare the dose response and safety of AP1189 combined with methotrexate versus methotrexate alone. Participants will attend scheduled visits to monitor their disease activity, safety, and tolerability of the treatment. Assessments include measuring changes in the Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) at week 12. The study also involves physical exams, joint assessments, blood tests for inflammation markers and antibodies, and safety monitoring. The total treatment period lasts 12 weeks, with ongoing evaluations throughout this time.

Researchers are evaluating the effects of two different methods of giving pegloticase, a drug for uncontrolled gout, combined with methotrexate (MTX). This Phase 3 trial compares pegloticase given as an 18 mg injection under the skin every two weeks with pegloticase given as an 8 mg intravenous (IV) infusion every two weeks, both alongside weekly oral MTX. The main goal is to see which method better maintains normalized serum uric acid levels below 6 mg/dL for at least 80% of the time during the sixth month of treatment. Participants will be randomly assigned to receive pegloticase either by subcutaneous injection or intravenous infusion every two weeks, along with weekly oral doses of methotrexate. Both groups will be treated over several months while closely monitored. The study is double-blind, meaning neither participants nor researchers know which treatment is being given to maintain unbiased results. During the trial, participants will undergo regular assessments to monitor their serum uric acid levels and overall response to treatment, especially focusing on weeks 20 through 24 (Month 6). Safety and efficacy will be tracked throughout the study, including how well participants tolerate the treatments and any side effects. The study's main measure is the proportion of participants who achieve a sustained uric acid response during Month 6.

Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.

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 short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are investigating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels in adults with hyperuricemia related to gout. This phase 3, randomized, double-blind trial focuses on adults aged 18 to 75 who have had gout for at least one year and experienced multiple gout flares in the past year. The study aims to assess the percentage of participants achieving an sUA level below 6.0 mg/dL at 24 weeks. Participants receive either dotinurad or allopurinol as oral over-encapsulated tablets. Allopurinol doses range from 200 mg/day for those with moderate kidney impairment to 600 mg/day, with participants maintaining a stable dose for at least three months before starting the study. The trial includes a 24-week treatment period where the effects of these medications on uric acid levels are monitored and compared. During the study, participants undergo regular assessments including serum uric acid measurements at screening and throughout the 24 weeks. Female participants of childbearing potential have pregnancy tests and must agree to contraception requirements. Researchers monitor safety, treatment adherence, and gout flare history to evaluate the treatments' efficacy and tolerability over the study period.

Researchers are investigating how well retatrutide works and how safe it is for relieving chronic low back pain in adults who are overweight or have obesity. This Phase 3 study focuses on people with this specific type of ongoing back pain and a body mass index (BMI) of 27 or higher. Participants will be followed for about 80 weeks to assess treatment effects. Participants will receive either retatrutide or a placebo, both given by subcutaneous injection once a week. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. This design helps compare the effects of retatrutide against no active treatment over the study period. During the study, researchers will monitor changes in pain intensity using a numeric rating scale and track body weight changes from the start of the study up to 72 weeks. Participants will undergo regular assessments to evaluate safety and treatment impact. The entire participation will last around 80 weeks, allowing careful observation of long-term effects and safety.