Montfermeil

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 brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

Researchers are evaluating the safety and effectiveness of SAR444336 in adults with microscopic colitis who are currently in clinical remission and receiving budesonide therapy. This Phase 2, randomized, double-blind, placebo-controlled study involves multiple centers and aims to test whether SAR444336 can help maintain remission without steroids in this patient group. Participants must have a confirmed histological diagnosis of microscopic colitis and a history of relapse requiring treatment in the past eight months. The total study duration is about 32 weeks. Participants will receive either SAR444336 or a placebo, both given as subcutaneous injections. The study includes a parallel-group design where one group receives the active drug and the other a matching placebo. The treatment period and dosing details are structured to assess the drug's impact on maintaining remission while monitoring safety and tolerability. During the study, participants will be closely monitored for their clinical status, including whether they remain in steroid-free remission up to 24 weeks. Assessments include clinical evaluations, laboratory tests, and safety monitoring. Researchers will track the occurrence of relapses and any side effects to determine the proportion of patients who sustain remission. The study involves screening, treatment, and follow-up visits over the 32-week period to ensure participant safety and collect data on treatment outcomes.

Researchers are investigating treatments for adults with moderate to severe ulcerative colitis who have not responded well to steroids or other therapies. This Phase IV, randomized, open-label, multicenter trial aims to compare standard care with a treat-to-target approach using telemonitoring and patient education for those starting adalimumab (Humira4). The study will assess if home fecal calprotectin testing combined with e-monitoring and education improves patient outcomes by week 48. All participants will begin treatment with adalimumab at doses of 160 mg, then 80 mg, and 40 mg every other week until week 14, followed by 40 mg every other week until week 26. Based on patient and doctor preference, doses can be adjusted up to 80 mg every other week for two months and continued with azathioprine or methotrexate until week 38. Patients will also receive patient education sessions at weeks 0, 2, 14, 26, and 38, along with regular e-monitoring throughout the study. Participants will be followed for a total of 144 weeks across 20 sites in France. The main outcome is endoscopic remission at week 48, measured by an endoscopic Mayo score of 0. Additional assessments include clinical remission, steroid-free remission, healing rates, quality of life, patient satisfaction, safety, pharmacokinetics, hospitalizations, treatment adherence, and economic impact. Patients will report stool frequency, bleeding, and injection details via e-monitoring at multiple time points. This comprehensive monitoring aims to evaluate treatment effectiveness and patient engagement over time.

Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic condition affecting the digestive tract and often diagnosed in adolescents and young adults. While anti-TNFalpha therapies can reduce disease activity and improve quality of life, they may cause side effects like fatigue, weight gain, and joint pain. Light to moderate physical activity might help reduce inflammation and improve outcomes, but access to structured programs is limited. This pilot study aims to evaluate the feasibility and impact of a remote Adapted Physical Activity (APA) program on quality of life for patients with IBD over 12 weeks. The study involves a before-and-after comparison over three months of a remote APA program delivered via the MOOV+ application. Participants will engage in this physical activity program at home using a digital device with internet access. The intervention focuses on adapting physical activity to suit the patients' needs, aiming to support symptom management and overall well-being. Participants will be assessed at the start and after 3 months to measure changes in their quality of life, anxiety, depression, fatigue, IBD activity, and smoking behavior. The study requires medical clearance for remote physical activity and will monitor participant engagement through the MOOV+ app. Findings may help develop accessible non-drug strategies to enhance life quality in people living with IBD.