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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.
Actively Recruiting
Parkinson's disease (PD) is a neurological disorder that affects the brain and worsens over time, with symptoms such as tremors, stiffness, and slowness of movement. This study aims to evaluate how effective Foslevodopa/Foscarbidopa is in treating adults with advanced Parkinson's Disease in Belgium under regular clinical care. Approximately 120 adult participants will take part across 15 sites in Belgium. Participants will receive Foslevodopa/Foscarbidopa through a subcutaneous infusion as prescribed by their doctors. The study is observational and will follow participants for up to 18 months, with treatment administered according to routine clinical practice. There are no additional treatments or interventions beyond what the physician decides. During the study, participants will attend regular hospital or clinic visits as part of their usual care. Researchers will monitor changes in disease symptoms, including measuring OFF time in hours using a standardized Parkinson's disease rating scale over approximately 6 months. The study focuses on evaluating the real-life effectiveness of this subcutaneous treatment while minimizing extra burden on participants.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of obefazimod compared to a placebo in adults with moderately to severely active Crohn's Disease who have not responded well or are intolerant to conventional or advanced treatments. The study is a Phase 2b trial and includes three treatment phases: a 12-week Induction Phase, a 40-week Maintenance Phase, and a 48-week Extension Phase. The main goals are to assess how well obefazimod controls disease activity and its safety over these periods. Participants will receive either obefazimod or a matching placebo once daily, preferably in the morning with food. The trial includes an initial 12-week treatment to induce response, followed by a 40-week maintenance period to sustain results. Those who complete these phases may enter a 48-week Extension Phase to further evaluate the long-term safety and tolerability of obefazimod compared to placebo. During the study, participants will undergo regular assessments including clinical evaluations of disease activity using the Crohn's Disease Activity Index and endoscopic scoring at various time points up to week 52. Safety is monitored throughout, especially during the Extension Phase with checks for adverse events, blood tests, and other laboratory evaluations at scheduled visits. Overall, participation may last over a year, with careful monitoring of treatment effects and safety.
Actively Recruiting
Researchers are investigating whether starting biological therapy based on endoscopy results after surgery is as effective as routinely giving biological therapy to prevent Crohn's disease from coming back. This study is a phase 4, randomized, multicenter trial focusing on patients who have had ileocolonic resection with ileocolonic anastomosis. The goal is to see if the endoscopy-driven approach leads to similar rates of postoperative endoscopic recurrence at 86 weeks compared to systematic biological treatment. Secondary analyses will look at clinical, biological, and surgical recurrence, side effects, costs, work productivity, and quality of life. Images from the study will also help create a new scoring system to evaluate recurrence after surgery. Participants are randomly assigned to one of two groups. One group receives biological therapy (adalimumab, infliximab, ustekinumab, vedolizumab, or risankizumab) within 14 to 40 days after surgery as preventive treatment. The other group waits until an endoscopic evaluation at week 30; if recurrence is seen then, biological therapy starts with a standard induction and maintenance schedule. Biological therapy can be adjusted based on clinical practice from week 32 onwards in both groups. Patients showing clinical recurrence after week 32 but not on biological therapy may start treatment, which counts as study failure. The choice of biological drug is made before study start, considering treatment history and patient discussion. During the study, participants undergo endoscopic evaluations including scoring for disease recurrence. Researchers also monitor clinical signs, biological markers, and need for treatment changes up to 86 weeks. Data on safety, quality of life, work productivity, and costs are collected. The total treatment and observation period lasts 86 weeks postoperatively. This approach aims to personalize postoperative care for Crohn's disease while potentially reducing unnecessary early biological therapy.
Actively Recruiting
Researchers are evaluating a structured rehabilitation pathway called the R³ pathway for patients undergoing lumbar surgery due to radicular pain, such as lumbar radiculopathy and radicular low back pain. This multicenter cluster randomized controlled trial compares the R³ pathway to usual care, aiming to see if this approach can reduce the time it takes for patients to return to work after surgery. The study focuses on a person-centered rehabilitation that supports patients through pre-, peri-, and postoperative phases while promoting early activity and work resumption. The R³ rehabilitation pathway involves a case manager guiding patients from before surgery up to one year after surgery. It includes prehabilitation, perioperative care, and postoperative rehabilitation emphasizing minimal activity restrictions, eliminating the use of braces, and active encouragement to resume work early. Hospitals participating in the trial are randomly assigned to either implement this pathway or continue with their usual care methods. The pathway specifically targets fear reduction and structured support to improve recovery. Participants will be monitored from surgery through 15 months postoperatively, with the main outcome being the time it takes to return to work. This involves regular assessments throughout the year following surgery to evaluate recovery progress and work reintegration. The study includes ongoing follow-up to understand the impact of the rehabilitation pathway compared to standard care on patient outcomes related to work and recovery.
Actively Recruiting
Researchers are investigating the effect of 2LPAPI4, an immune regulator, on clearing genital high-risk human papillomavirus (HR-HPV) infections. The study focuses on women aged 25 to 45 with diagnosed HR-HPV infections identified during routine cervical cancer screenings. This phase 4, placebo-controlled trial aims to compare 2LPAPI4 to a placebo in terms of clearing these infections, following current guidelines that recommend monitoring rather than immediate treatment after initial detection of HR-HPV. Participants will be divided into two groups: one receiving 2LPAPI4 and the other receiving a placebo, each treated for six months. After the treatment phase, there will be a six-month follow-up to assess infection clearance and cytology results. Treatment success is defined by the elimination of HR-HPV and normalization of cervical cell changes. The study plans to include 284 women, with 142 in each group, and may extend recruitment beyond 60 months if needed. During the study, participants will undergo cytology tests and HPV typing at baseline, six months, and twelve months. Researchers will monitor infection clearance rates, cytological changes, and any adverse events related to the treatment. Participants must be able to maintain a stable sexual relationship and comply with study requirements for the full 12-month duration. Safety and effectiveness data will be collected throughout the study to understand better how 2LPAPI4 may impact HR-HPV infections.
Actively Recruiting
Researchers are evaluating the use of subcutaneous infliximab in adults with inflammatory bowel diseases (IBD) such as Crohn's disease, ulcerative colitis, and IBD type unclassified. This study focuses on patients who were previously treated with an optimized dose of intravenous infliximab and are currently in steroid-free clinical and biological remission. The trial aims to determine whether a weekly dose of subcutaneous infliximab leads to better outcomes compared to the standard bi-weekly dosing in these patients. Participants will switch from intravenous infliximab to subcutaneous infliximab and will be randomly assigned to receive either weekly or bi-weekly subcutaneous injections. A comparison group of patients who prefer to continue their optimized intravenous infliximab treatment will also be observed. The study will follow patients for one year, with assessments at weeks 0, 8, 24, and 52, though timing may vary based on individual intravenous dosing schedules. During the study, participants will undergo physical exams, blood and stool tests, and complete questionnaires about their health-related quality of life. Those switching to subcutaneous infliximab will also keep a diary of their home injections and answer questions about their experience. The main outcome measured is the proportion of patients who maintain steroid-free clinical and biological remission at week 52 without needing treatment changes. Safety and treatment satisfaction will also be monitored throughout the year.