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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.
Actively Recruiting
Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.
Actively Recruiting
Parkinsons disease PD is a neurological disorder that affects the brain and worsens over time, with symptoms such as tremors, stiffness, and slow movement. This research aims to assess how effective FoslevodopaFoscarbidopa is in treating adults with advanced Parkinsons Disease in Belgium under routine clinical practice. Approximately 120 adult participants prescribed this treatment will be studied across multiple sites. Participants will receive FoslevodopaFoscarbidopa through subcutaneous infusion as directed by their doctors according to local guidelines. This observational study does not involve additional interventions beyond routine care. Participants will continue their usual treatment while being followed for up to 18 months. During the study, participants will attend regular hospital or clinic visits as part of their standard care. Researchers will monitor changes in symptoms, focusing on OFF time periods when medication effects wear off measured by a specific Parkinsons rating scale over approximately six months. The study involves no extra procedures or burdens beyond routine practice and aims to collect data on the treatments impact over time.
Actively Recruiting
Researchers are studying obefazimod to evaluate its effectiveness and safety as a treatment for adults with moderately to severely active Crohns disease who have not responded well or cannot tolerate conventional or advanced therapies. This Phase 2b trial compares obefazimod with a placebo to see if it can help control symptoms and improve disease activity. The study also aims to assess the long-term safety and tolerability of obefazimod during an extension period. The study includes three treatment phases a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. Participants receive one of four daily treatments obefazimod at doses of 50mg, 25mg, or 12.5mg, or a placebo. All treatments are taken once daily, ideally in the morning with food. The extension phase focuses on monitoring safety and tolerability compared to placebo. Participants will attend regular study visits for assessments including the Crohns Disease Activity Index and endoscopic scores to measure disease activity and response. Safety is monitored through adverse event reports and laboratory tests, including blood work for hematology, coagulation, and biochemistry at various weeks up to the end of the study. The total study duration spans several phases, allowing close observation of treatment effects and safety over time.
Actively Recruiting
The trial investigates how to best prevent postoperative endoscopic recurrence in patients with Crohns disease who have undergone ileocolonic resection with anastomosis. Researchers are comparing an endoscopy-driven approach to starting biological therapy only when signs of recurrence appear, versus starting systematic prophylactic biological therapy shortly after surgery. This pragmatic randomized trial aims to assess whether the endoscopy-driven strategy leads to similar rates of disease recurrence and other outcomes at week 86, while also evaluating clinical recurrence, safety, costs, work productivity, and quality of life. Additionally, endoscopic images will be used to develop a new scoring system for postoperative recurrence. Participants are randomly assigned to one of two groups. The systematic prophylaxis group starts biological therapy adalimumab, infliximab, ustekinumab, vedolizumab, or risankizumab within 14 to 40 days post-surgery, with specific dosing schedules depending on the drug. The endoscopy-driven group does not receive therapy until week 30, when an endoscopic evaluation is done those with recurrence then start biological therapy following induction and maintenance dosing. Dose optimization is allowed after week 32 in both groups based on clinical practice and drug monitoring. Randomization is stratified by therapy type and risk factors for recurrence. During the study, participants undergo clinical assessments including endoscopies at week 30 and week 86, blood tests, and monitoring of symptoms and quality of life. Researchers track disease recurrence by endoscopic scores and clinical indices like the Harvey-Bradshaw Index. Safety events, treatment adaptations, healthcare costs, and surgery rates are recorded. Study participation lasts until week 86 after surgery, with ongoing data collection to evaluate treatment impact and outcomes in this Crohns disease population.
Actively Recruiting
Researchers are evaluating a structured, evidence-based rehabilitation pathway called the R pathway for patients undergoing lumbar surgery due to radicular pain. This multicenter cluster randomized controlled trial compares the R pathway against usual care to see if it can reduce the time it takes for patients to return to work after surgery. The study focuses on patients aged 18 to 65 scheduled for lumbar spinal surgery with radicular pain lasting at least six weeks. The R rehabilitation pathway involves coordinated care guided by a case manager, starting before surgery and continuing up to one year afterward. It includes prehabilitation, perioperative rehabilitation, and postoperative rehabilitation, aiming to reduce fear by minimizing unnecessary activity restrictions, eliminating bracing, and actively encouraging return to work. Hospitals are randomized to either implement the R pathway or continue with their usual variable rehabilitation care, which may include no rehabilitation or various types of therapy. Participants will be monitored from surgery through 15 months postoperatively. Researchers will assess the time to return to work as the primary outcome. Secondary outcomes include disability, percentage of patients returned to work, functional status, back and leg pain, health-related quality of life, work productivity, analgesic use, kinesiophobia, and pain catastrophizing at multiple time points. The study requires written consent and involves follow-up assessments to evaluate recovery and work reintegration.
Actively Recruiting
This research is focused on women aged 25 to 45 years who have been diagnosed with high-risk human papillomavirus HR-HPV infections during routine cervical cancer screening. The study aims to evaluate the effectiveness of 2LPAPI4, an immune regulator used to treat HR-HPV infections, in clearing genital HR-HPV compared to a placebo. The trial follows recommendations for triage and follow-up in HR-HPV-positive women to better understand treatment impact on infection clearance and cytology changes. Participants will be randomly assigned to one of two groups one receiving 2LPAPI4 capsules and the other receiving placebo capsules. Each group will take one capsule daily, 15-30 minutes before breakfast on an empty stomach, for six continuous months. Following the treatment phase, there is a six-month follow-up period to monitor the clearance of the infection and normalization of cytology. During the study, participants will undergo regular cervical cytology tests and HR-HPV screenings at six and twelve months. Researchers will assess the clearance rates of HR-HPV infections, changes in cytology results, and safety by tracking any adverse events. The total study duration spans up to 72 months, including up to 60 months for patient recruitment and 12 months for follow-up after treatment completion.
Actively Recruiting
The trial investigates treatment options for adults with inflammatory bowel diseases IBD, including Crohns disease and ulcerative colitis, focusing on patients who were previously treated with an optimized dose of intravenous infliximab. The study aims to compare if switching to weekly subcutaneous infliximab leads to better clinical and biological remission outcomes than the standard bi-weekly subcutaneous administration. It also compares patients willing to switch to subcutaneous treatment with those continuing intravenous therapy. Participants who switch from intravenous infliximab will be randomly assigned to receive either 120 mg of subcutaneous infliximab weekly or every other week. Those not willing to switch will continue their existing intravenous dosing schedule. The study is conducted nationally with multiple centers, involving screening and follow-up visits over one year, with physical exams, clinical scoring, blood and stool analyses, and questionnaires about quality of life and treatment satisfaction. During the study, participants will have four visits with their gastroenterologist throughout one year, where clinical remission scores, lab tests, and medication use are assessed. Those on subcutaneous infliximab will keep a diary of at-home injections and complete satisfaction questionnaires. The primary measurement is the proportion of patients maintaining steroid-free clinical and biological remission without treatment changes at week 52. Researchers will also monitor treatment optimization, discontinuation, relapse timing, and patient experiences.