Echirolles

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.

Researchers are evaluating how well guselkumab works compared to risankizumab in adults with moderately to severely active Crohns Disease, a long-term condition causing severe inflammation in the intestinal tract. This Phase 3b study aims to compare the effectiveness and safety of these two drugs for treating this condition. Participants will be randomly assigned to one of two groups. One group will receive guselkumab with induction doses given under the skin at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks from Week 12 through Week 52. The other group will receive risankizumab with induction doses given intravenously at Weeks 0, 4, and 8, followed by maintenance doses under the skin every 8 weeks from Week 12 through Week 52. During the study, participants will be monitored for up to about three years to assess deep remission at Week 52 and other clinical outcomes such as clinical remission, endoscopic response, steroid-free remission, and safety measures including laboratory tests and adverse events. The study includes ongoing safety monitoring through Week 165 with regular assessments to track disease activity and treatment effects.

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.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Psoriatic arthritis PsA is a type of arthritis that causes joint swelling and stiffness, often occurring in people with the skin condition psoriasis. This study aims to understand how long patients continue treatment and how effective risankizumab RZB is compared to other advanced treatments for PsA in everyday clinical settings. The study will take place outside the United States across about 15 countries, involving between 900 and 1200 adult participants. Participants will receive either risankizumab or other biologic disease-modifying antirheumatic drugs bDMARDs as prescribed by their doctors following local guidelines. Treatments will be given as part of regular medical care without additional interventions from the study. Participants will be followed and observed for 24 months during their routine clinical visits. During the study, participants will attend their usual medical appointments where doctors will monitor their treatment persistence and response. The main outcome measured is how many participants continue their prescribed treatment up to 24 months. There is no expected extra burden or additional procedures for participants beyond their standard care.

Researchers are evaluating the safety and effects of arterial embolization using Lipiodol4 in patients with symptomatic hand osteoarthritis who have not responded to conventional treatments. This pilot study aims to understand the side effects and complications linked to the procedure, as well as its ability to reduce pain and improve hand function over a 6-month period. The study is sponsored by University Hospital, Grenoble, and includes patients aged 40 years and older with specific hand osteoarthritis symptoms and pain levels. Participants will undergo arterial embolization of the radial artery in the most painful hand using Lipiodol mixed with iodinated contrast medium. The procedure targets blood vessels supplying the affected joints. After treatment, patients will have regular follow-ups to monitor pain relief, swelling, joint function, and any side effects. Imaging studies such as ultrasound and arteriography will be used to assess changes in joint vascularization and damage over time. During the study, participants will be assessed for adverse events related to embolization using standard criteria from the time of treatment up to six months afterward. Pain intensity, joint swelling and tenderness, hand function, grip strength, and joint vascularization will be measured at baseline and at 1, 3, and 6 months post-treatment. Researchers will also monitor changes in the use of pain medications and hand microcirculation. The total participation duration is six months, with careful safety monitoring throughout.

Researchers are evaluating whether treatment with both mirikizumab and tirzepatide compared to mirikizumab and placebo can reduce or eliminate symptoms of moderately to severely active ulcerative colitis UC in adults who are also overweight or have obesity. This Phase 3b randomized controlled study aims to determine if this combination treatment leads to clinical remission and at least a 10% reduction in body weight. Participants receive mirikizumab initially by intravenous IV infusion followed by subcutaneous SC injections. They are randomly assigned to receive either tirzepatide SC or a placebo SC alongside mirikizumab. The treatment period lasts for 52 weeks, with the whole study participation lasting up to 61 weeks. Both study drugs and placebo are administered under medical supervision. During the study, participants are monitored regularly for symptom improvement and weight loss. Researchers assess clinical remission, endoscopic response, histologic-endoscopic mucosal improvement, bowel movement urgency, and histologic remission at weeks 24 and 52. Safety and treatment effects are carefully followed throughout the trial. Participants undergo evaluations to measure changes in UC symptoms and body weight over the study period.

Researchers are evaluating the effectiveness and safety of mirikizumab combined with either tirzepatide or a placebo in adults with moderately to severely active Crohns disease who also have obesity or are overweight. This Phase 3b study aims to compare these treatments in participants who have a confirmed diagnosis and meet specific disease activity and weight criteria. The study is conducted by Eli Lilly and Company and lasts up to 61 weeks. Participants receive mirikizumab initially via intravenous infusion, followed by subcutaneous injections. They are randomly assigned to receive either tirzepatide with mirikizumab or placebo with mirikizumab, both administered subcutaneously. The study involves two experimental groups where treatments are given according to this schedule. During the study, participants will undergo regular assessments to monitor clinical remission using the Crohns Disease Activity Index and endoscopic remission, as well as track weight reduction. Evaluations include inflammatory bowel disease questionnaires and monitoring of corticosteroid use. The main measure is the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight loss by week 52. Safety and maintenance of remission are also assessed throughout the trial.

Researchers are evaluating the use of cryocompression compared to traditional icepacks to reduce inflammation and pain after total knee replacement surgery. This trial aims to assess whether cryocompression offers any additional benefit over icepacks in managing post-operative pain and healing. Previous studies have shown mixed results, and this study addresses uncertainties about cryocompressions effects on pain, mobility, wound healing, and opioid use. Participants will be randomly assigned to receive either cryocompression or icepacks immediately after surgery while staying in the hospital for 1 to 3 days. Both groups will use their assigned method continuously for 4 hours directly following surgery to reduce inflammation. The study compares these two non-invasive devices for post-operative care. Throughout the study and follow-up periods up to 9 months, participants will undergo assessments of pain, joint function, mobility, swelling, wound healing, blood loss, pain medication use, quality of sleep, and procedure safety. Data will be collected at specific time points including 48 hours, 1 month, 3 months, and 9 months after surgery to monitor recovery and outcomes carefully.

This research aims to assess how a prosthetic foot with an adjustable heel height affects physical appearance and social participation in adults with major lower limb amputations. The study addresses the challenge that most prosthetic feet have a fixed heel height, which limits users to wearing shoes with the same heel height. Being able to choose different shoes freely is important for coping with physical disability and maintaining lifestyle preferences. Participants will use two types of prosthetic feet in a randomized order. One device is the Taleo Adjust foot, which features a hydraulic ankle allowing adjustable heel heights from 0 to 7 cm to match different shoe types without compromising walking quality. The other is the participants usual energy storage and return ESR foot with a fixed heel height. Each foot will be worn for 30 days, with participants either starting with the Taleo Adjust foot then switching to their usual foot, or vice versa. During the study, participants will be assessed using questionnaires and scales that measure appearance satisfaction, functional ability, psychosocial impact, device satisfaction, quality of life, mobility, and socket comfort. The primary outcome is the Prosthetic Evaluation Questionnaire - Appearance scale after 30 days of use for each foot. The study includes monitoring participant experiences and measuring how the adjustable heel foot influences daily activities and social participation over the two 30-day periods.