Echirolles

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.

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.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Psoriatic arthritis (PsA) is a type of arthritis that causes joint swelling and stiffness and is often seen in people with the skin condition psoriasis. It results from an overactive immune system attacking healthy tissue. This research aims to describe the long-term use and effectiveness of risankizumab (RZB) compared to other advanced treatments for managing PsA in everyday clinical care. The study is not conducted in the United States but will take place in about 15 countries and include between 900 and 1200 adult participants. Participants will be assigned in a 2 to 1 ratio to receive either risankizumab or other advanced therapeutic agents. The treatments will be given following usual medical guidelines, including approved dosing and indications, as determined by local regulations and professional standards. All study visits will occur during routine clinical care with no extra burden on participants. Participants will be followed and monitored for 24 months to observe treatment persistence. During the study, participants will continue their regular clinical visits without additional procedures or tests required by the study. Researchers will measure how many participants continue their prescribed treatment over the 24-month period. The study focuses on real-world treatment patterns and outcomes in patients with active PsA who have previously shown an inadequate response or intolerance to certain medications. Safety monitoring will align with routine clinical practice throughout the study duration.

Researchers are investigating the safety and effectiveness of arterial embolization using Lipiodol® in patients aged 40 and older who have symptomatic hand osteoarthritis that has not improved with conventional treatments. This early-phase study aims to understand the side effects and complications of this procedure and whether it can reduce pain and improve hand function over a six-month period. Participants will receive hand arterial embolization with Lipiodol® mixed with an iodinated contrast agent. The study will track their progress through regular follow-up visits where pain relief, hand function, and any side effects will be monitored. Imaging studies will also be performed to observe changes in joint blood flow and damage. During the six months following embolization, participants will undergo various assessments including monitoring for embolization-related adverse events, evaluation of pain intensity, swelling, and hand function. Researchers will use these data to measure the safety of the procedure and its impact on joint health and quality of life.

Researchers are investigating if combining mirikizumab with tirzepatide can reduce symptoms of moderately to severely active ulcerative colitis (UC) and help adults with obesity or overweight lose at least 10% of their body weight. This Phase 3b study compares this combination treatment to mirikizumab with a placebo to see which is more effective over a 52-week treatment period, followed by additional monitoring up to 61 weeks. Participants receive mirikizumab either intravenously (IV) or subcutaneously (SC), along with either tirzepatide or a placebo administered subcutaneously. The study randomly assigns adults with UC and obesity or overweight into these treatment groups to evaluate the effects over the full treatment duration. During the study, participants will undergo various assessments including evaluations of UC symptoms and body weight changes. Researchers will measure the percentage of participants who achieve clinical remission of UC and at least 10% weight loss at week 52. Safety and health monitoring will continue throughout the study to ensure participant well-being during the treatment and follow-up periods, which together can last up to 61 weeks.

Researchers are evaluating the effectiveness and safety of mirikizumab alone or combined with tirzepatide compared to mirikizumab with placebo in adults who have moderately to severely active Crohn's disease along with obesity or overweight conditions. This Phase 3b study focuses on patients with confirmed Crohn's disease or perianal fistulizing Crohn's disease who also meet specific weight-related criteria and have shown inadequate response or intolerance to previous Crohn's disease treatments. The study may last up to 61 weeks. Participants receive treatments involving mirikizumab administered intravenously or subcutaneously, tirzepatide given subcutaneously, or placebo administered subcutaneously. The trial includes groups receiving mirikizumab with placebo or mirikizumab combined with tirzepatide to compare outcomes. Dosage schedules and exact administration details are provided throughout the treatment period. During the study, participants will undergo various assessments including clinical evaluations using the Crohn's Disease Activity Index, endoscopic examinations, and monitoring of weight changes. Researchers will track the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight reduction by week 52. Safety and response to treatments will be closely monitored throughout the duration of up to 61 weeks.

This research evaluates the use of cryocompression compared to traditional icepacks for managing pain and inflammation following total knee replacement surgery. The study focuses on whether these two methods differ in reducing post-operative pain at 48 hours after surgery. Cryocompression devices, which combine cold therapy with compression, have shown benefits in reducing inflammation in other types of surgeries, but their effectiveness and impact on wound healing after knee replacement remains uncertain due to limited prior research and small study sizes. Participants will be randomly assigned to receive either cryocompression using the Game Ready device or standard icepacks immediately after surgery. Both treatments involve applying the cold therapy continuously for four hours in the hospital's recovery area, followed by continued use during the patient's 1 to 3-day hospital stay. The study compares these two approaches as non-invasive, non-drug options for managing inflammation and pain after knee replacement. During the study, researchers will assess pain levels 48 hours after surgery along with other recovery measures such as knee movement and opioid use. Participants will be monitored closely throughout their hospital stay with assessments to evaluate pain, inflammation, and healing. The study aims to provide clearer evidence on whether cryocompression offers advantages over icepacks, helping inform post-operative care decisions for patients undergoing total knee replacement.

Researchers are studying patients who have both chronic obstructive pulmonary disease (COPD) and heart failure (HF), conditions that often occur together and cause problems with oxygen delivery in the body. This study aims to understand how poor oxygen delivery during exercise affects muscle and brain fatigue in people with COPD-HF overlap, and whether treatments that improve oxygen delivery can reduce this fatigue. The study focuses on neuromuscular fatigue during exercise and explores the effects of specific interventions to improve oxygen supply. Participants will exercise under two different conditions. One involves breathing medical air during exercise, which serves as a control condition where both study arms are exposed. The other condition uses hyperoxia, where participants breathe a gas mixture with higher oxygen levels, but only the experimental arm receives this treatment. These interventions are tested to see how they influence muscle and brain oxygenation and fatigue during exercise. Throughout the study, researchers will assess muscle fatigue immediately after exercise by comparing results between patients with COPD alone and those with both COPD and HF under the medical air condition, as well as comparing the effects of medical air versus hyperoxia in patients with COPD-HF. Participants will undergo exercise tests and oxygen delivery measurements to evaluate neuromuscular fatigue. The study requires participants to be clinically stable, able to perform cycle ergometry, and able to provide informed consent. Safety and adherence will be monitored during the study period.

This research investigates the impact of a prosthetic foot with an adjustable heel height on physical appearance and participation for adults with major lower limb amputations. Most prosthetic feet have a fixed heel height, which limits users to shoes of the same heel height and restricts their choice of footwear. The study aims to address this limitation by evaluating a device that allows users to freely choose different types of shoes, enhancing their ability to cope with physical disability. The study compares the Taleo Adjust prosthetic foot, which features a hydraulic ankle allowing heel height adjustment from 0 to 7 cm, with the participant's usual Energy Storage and Return (ESR) prosthetic foot that has a fixed heel height. The adjustable foot preserves prosthetic alignment and walking quality across different heel heights. Participants will use both types of prosthetic feet in a randomized crossover design to assess differences. Participants will be evaluated through the Prosthetic Evaluation Questionnaire focusing on appearance after 30 days of use. Researchers will monitor physical appearance, social participation, and user satisfaction related to the adjustable heel height feature. The study includes assessments of walking ability with various shoe types and barefoot, with ongoing monitoring of alignment, comfort, and participation outcomes throughout the study period.