Gout

Researchers are investigating the safety, tolerability, pharmacokinetics, and effectiveness of the drug IG3018 in people with high uric acid levels hyperuricemia, including those with and without chronic kidney disease CKD. This phase III clinical trial aims to better understand how IG3018 works in these groups and to explore appropriate dosing. The study is sponsored by Intelligem Therapeutics Australia Pty Ltd and includes participants aged 18 to 75 years. The trial has two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study in participants without CKD, testing increasing doses of IG3018 tablets 0.25 g, 0.5 g, and 1.0 g. Each dose cohort receives a single dose followed by four weeks of twice-daily maintenance dosing. Part 2 is an open-label study in participants with advanced predialysis CKD Stages 3a, 3b, and 4, who receive either 0.5 g or 1.0 g of IG3018 twice daily for four weeks. Participants will attend study visits for blood and urine sample collection to analyze drug levels and kidney function. Safety and efficacy will be assessed through laboratory tests, gout attack monitoring, and uric acid measurements over about 46 days. The study tracks changes in serum uric acid levels, kidney function markers, and drug pharmacokinetics. Participants must provide consent and follow study procedures throughout the treatment and monitoring periods.

Researchers are studying pyrimidine and purine metabolism disorders DPPMs, which affect how the body processes certain chemicals and can lead to problems in the brain, blood, kidneys, and immune system. These disorders vary widely in severity, and this study aims to better understand their causes, features, and outcomes by observing affected individuals, their family members, and healthy volunteers. Participants with DPPMs will visit the clinic at least once a year, sometimes more often. They will undergo physical exams and provide samples of blood, urine, saliva, and stool. Additional tests may include skin and mouth swabs, heart, kidney, brain, and nerve function tests, questionnaires about diet, dental, hearing, and vision exams, learning ability assessments, physical activity monitoring, imaging scans, and photographs. These evaluations may take place over several days, and affected participants can stay in the study indefinitely if they choose. Family members and healthy volunteers will have a single study visit with physical exams and sample collection. Participants will be closely monitored through various medical, laboratory, and imaging studies to gather detailed information. Researchers will analyze genetic material, biochemical markers, enzyme activities, microbiome samples, and clinical data to identify factors related to DPPMs. The study aims to describe features of these disorders and discover genetic, clinical, laboratory, and dietary elements that influence health outcomes. The study may continue for many years, allowing ongoing observation and data collection.

Researchers are evaluating dotinurad, an oral drug, to lower serum uric acid levels in adults with gout who cannot tolerate xanthine oxidase inhibitors XOI or whose uricase treatment has failed. This Phase 2 randomized, double-blind, placebo-controlled study aims to assess the drugs effectiveness and safety in this specific population. The primary goal is to see how many participants achieve a serum uric acid level below 6.0 mgdL at 24 weeks. Participants will be divided into two groups. One group will take dotinurad for 36 weeks, split into a 24-week initial period followed by a 12-week continuation. The other group will take a placebo for the first 24 weeks and then switch to dotinurad for the final 12 weeks. Dotinurad is given as an oral tablet, while the placebo capsules contain inactive ingredients. This design allows comparison of the drug against placebo and later observation of dotinurads effects. During the study, participants will have their serum uric acid measured at various points, especially at weeks 16, 20, 24, and up to week 40. Researchers will monitor treatment-emergent adverse events throughout the study period. Participants will be followed from screening through treatment and safety assessments, with the primary focus on uric acid levels at week 24. The total study duration for each participant covers screening and up to 40 weeks of follow-up.

Researchers are studying the safety and tolerability of peguricase injections combined with methotrexate in adults with gout who have not responded well to standard uric acid-lowering treatments. This phase Ib trial also aims to understand how the drug behaves in the body and its initial effectiveness to help determine the best dose and treatment plan for future phase II trials. Participants receive peguricase injections in one of three dose groups 4 mg, 8 mg, or 12 mg. Each group starts with a single dose followed by a 5-day safety observation. If no issues arise, participants then receive multiple doses combined with methotrexate, an oral medication at 15 mg. The multi-dose phase begins 2 to 4 weeks after the single dose phase. Each dose group includes 12 participants. Throughout the study, participants will be monitored for adverse and serious adverse events, and blood samples will be taken to measure how the drug is processed by the body. Researchers will track various markers including drug concentration over time and antibody responses for up to 14 weeks after the first dose. Participants must be able to attend all visits and complete assessments on schedule during the study period.

This research aims to assess the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty, synthetic bone graft extenders, compared to autogenous bone graft in patients undergoing hindfoot or ankle fusions. The study focuses on treating hindfoot and ankle disorders requiring rigid hardware fixation and supplemental bone graft or substitute. It is a randomized, single-blind, controlled, multi-center phase IV post-marketing study involving adult patients aged 18 to 75 years. Participants will be randomly assigned to receive either MagnetOs PuttyEasypack Putty or autograft harvested from the calcaneus, distal tibia, or proximal tibia along with rigid hardware fixation during surgery. The volume used depends on the joint fused, with 1-5 cc for talonavicular, calcaneocuboid, and subtalar joints, and up to 10 cc for the tibiotalar joint. The surgical procedures include ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or double fusion of two of these joints. Participants will be followed up with radiographs at screening and weeks 6, 12, 24, and 52 post-surgery, with CT scans at weeks 24 and 52 to evaluate radiographic fusion. Functional assessments will also be conducted throughout the study period. If secondary surgical interventions occur after six months, CT scans may be adjusted. The primary outcome is radiographic fusion by CT scan at 24 weeks post-operation. Safety and efficacy are monitored for one year after surgery, with weight-bearing X-rays starting at week 12.

Researchers are studying the experiences of people who develop rheumatic immune-related adverse events irAEs after receiving immune checkpoint inhibitor immunotherapy. This study aims to understand how severe these events are, how they affect daily function, and the attitudes of patients towards different aspects of these side effects. The research focuses on conditions like arthritis and polymyalgia rheumatica that arise following this cancer treatment. This observational study does not involve any drug or treatment interventions. Instead, it gathers information through qualitative assessments from patients diagnosed by rheumatologists with inflammatory arthritis or polymyalgia rheumatica as irAEs after immune checkpoint inhibitor therapy. The study is sponsored by M.D. Anderson Cancer Center and will collect data over about one year. Participants will engage in interviews to share their experiences, which will help researchers evaluate the safety and adverse events associated with these immune-related conditions. The study includes monitoring adverse events throughout the study period. The total involvement duration averages one year, allowing for comprehensive understanding of the impact and progression of these rheumatic irAEs.

Researchers are evaluating an investigational drug called NNC4004-0002 to see if it can lower serum uric acid levels safely in adults with asymptomatic hyperuricemia. This is a Phase 1, double-blinded, placebo-controlled study where the safety and tolerability of a single dose of NNC4004-0002 will be tested for the first time in humans. The study aims to understand how the body handles this new medicine and its effects over time. Participants will receive either a single ascending dose of NNC4004-0002 or a matching placebo, both given as injections under the skin. The study includes up to six groups, each receiving different doses to assess safety and dose effects. Depending on the dose, participants may receive more than one injection. The study will last about 19 months in total, with each participant involved for approximately 7 months. During the study, participants will visit the clinic about 14 times, including a 4-night stay at the clinic. Researchers will monitor for any adverse events, measure the drug levels in the blood up to 72 hours after dosing, assess kidney clearance, and track changes in serum uric acid from baseline until about 28 weeks after dosing. Safety tests, physical exams, and lab tests will be conducted to ensure participant well-being throughout the study period.

This trial evaluates the effectiveness of dotinurad compared with allopurinol in lowering serum uric acid levels in adults with gout-related hyperuricemia. The study focuses on reducing uric acid to below 6.0 mgdL after 24 weeks of treatment, addressing a common complication in gout patients. It is a phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years with a history of gout. Participants are randomly assigned to one of three groups one group continues allopurinol at their existing dose once daily through week 64 the second group receives dotinurad starting at 1 mg once daily for the first 4 weeks, then 2 mg once daily through week 64 the third group begins with 1 mg daily for 4 weeks, increases to 2 mg daily for 8 weeks, then continues 4 mg daily through week 64. All treatments are administered orally as over-encapsulated tablets. Throughout the study, participants undergo regular monitoring of serum uric acid levels and gout flares from baseline up to week 68. Assessments include measuring the percentage of participants achieving target uric acid levels at various points, gout flare rates, and treatment-emergent adverse events. The study also evaluates safety and tolerability over the course of the treatment period, which lasts up to approximately 68 weeks including follow-up.

Researchers are evaluating the efficacy, safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of PRX-115, a recombinant pegylated Uricase, in adults with gout. This phase II, multicenter, randomized, double-blind, placebo-controlled study focuses on different intravenous infusion dosing regimens of PRX-115, with and without the immunomodulator methotrexate MTX, compared to placebos. The goal is to find the best dosing schedule and assess treatment effects over 24 weeks. Participants receive PRX-115 or placebo through intravenous infusions at varying intervals every 4 weeks six doses, every 6 weeks four doses, or every 8 weeks three doses. Some groups also receive oral methotrexate 15 mg weekly or a matching placebo. The study includes multiple treatment schedules combining these dosing regimens with or without MTX, allowing comparison of different approaches. Throughout the study, participants undergo regular assessments including blood tests to monitor serum uric acid levels, safety labs, and evaluations for adverse events. The primary outcome measures the percentage of patients achieving serum uric acid below 6 mgdL after 6 months of treatment. Safety and tolerability are closely monitored from enrollment until 8 months. The total participation length includes infusion visits and follow-up evaluations to gather comprehensive data on treatment impact and safety.

Researchers are evaluating the effectiveness of antigravity treadmill training and body weight-supported treadmill training for rehabilitation in elderly patients aged 60 to 75 years who have recently undergone hip or knee replacement surgery. The study compares these two methods to conventional gait training to see which approach may better support recovery and walking ability after surgery. Participants will be randomly assigned to one of three groups antigravity treadmill training, body weight-supported treadmill training, or conventional rehabilitation. Each group will undergo a 6-week program with five sessions per week. The antigravity treadmill uses air pressure to reduce weight on joints with gradually decreasing support, while the body weight-supported treadmill uses a harness to partially offload weight with a steady level of support. The conventional group receives standard postoperative therapy including gait training and physical therapy techniques. During the study, participants will receive comprehensive daily therapy including kinesitherapy, ergotherapy, and individualized physical therapy procedures. Researchers will assess outcomes such as pain and function using the Western Ontario and McMaster Universities Osteoarthritis Index, balance, mental health, stress, and walking parameters both before and after the 6-week intervention. The total participation period includes baseline assessments and the 6-week therapy program under professional supervision.