Montfermeil

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 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 safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

Researchers are evaluating the efficacy and safety of SAR444336 in adults with microscopic colitis who are currently in clinical remission and receiving budesonide therapy. This is a randomized, double-blind, placebo-controlled, Phase 2 study designed as a proof of concept to better understand this treatment in this patient population. The study is conducted across multiple centers with a total duration of about 32 weeks. Participants will be randomly assigned to receive either SAR444336 or a placebo. Both SAR444336 and placebo are given as several subcutaneous injections. Budesonide will continue to be taken at the dose prescribed by the participants physician. The study includes a treatment period where participants receive these injections while continuing their usual budesonide medication. During the study, participants will be monitored for sustained steroid-free clinical remission up to 24 weeks. Safety assessments will include tracking treatment-emergent adverse events, serious adverse events, and other safety-related outcomes up to 28 weeks. Plasma concentrations of SAR444336 and the presence of anti-drug antibodies will also be measured. Participants will undergo various evaluations throughout the study to assess efficacy and safety, with the entire involvement lasting about 32 weeks.

Researchers are evaluating a new approach for adults with moderate to severe ulcerative colitis who need treatment with adalimumab. This Phase IV randomized trial compares standard care with a treat-to-target strategy that includes telemonitoring and patient education. The study aims to assess the impact of using home fecal calprotectin tests and e-monitoring combined with education on disease control by week 48. All participants will initially receive adalimumab with doses starting at 1608040 mg every other week until week 14, then 40 mg every other week until week 26. Dosage may be adjusted up to 80 mg every other week or 40 mg every week based on patient or investigator choice. In addition, patients may receive azathioprine or methotrexate alongside adalimumab until week 38. The study groups differ by follow-up method one group receives standard care with doctor visits every three months, while the other group has e-monitoring, home fecal calprotectin testing, and therapy education. Participants will be involved for about 144 weeks and complete regular assessments including endoscopic exams, clinical evaluations, quality of life surveys, and treatment adherence questionnaires. The study measures success primarily by endoscopic remission at week 48 and also tracks clinical remission, healing rates, patient satisfaction, hospitalizations, colectomies, and safety. Monitoring includes frequent e-monitoring questionnaires and fecal calprotectin testing at home. The trial also evaluates medication compliance and economic outcomes related to treatment.

Inflammatory Bowel Disease IBD, including Crohns disease and ulcerative colitis, is a chronic condition affecting the digestive tract that is increasingly diagnosed in adolescents and young adults. This research aims to assess the feasibility and impact of a remotely delivered Adapted Physical Activity APA program on the quality of life for patients with IBD. The study focuses on evaluating changes after a 12-week APA intervention delivered via the MOOV application. Participants will take part in a 12-week remote APA program without a comparator group. The program is delivered through an app that guides physical activity tailored to the participants needs. Patient data will be compared before and after the intervention to assess the programs effects on quality of life and other health factors. During the study, participants will be assessed at the start and after 3 months of the APA program. Researchers will measure quality of life changes as the primary outcome, alongside secondary outcomes like anxiety, depression, fatigue, and IBD activity. The study will also evaluate feasibility, satisfaction, persistence of physical activity, and biological markers related to disease activity. Participation lasts at least 3 months, with continuous monitoring through the app.