Neuilly Sur Seine

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 the safety and side effects of the drug PF-08046054SGN-PDL1V alone and in combination with pembrolizumab in participants with advanced solid tumors. These tumors are either metastatic, meaning they have spread through the body, or unresectable, meaning they cannot be removed by surgery. The study is a Phase 1 trial designed to find the best dose and assess safety and potential treatment effects in these cancers. The study has five parts Parts A and B focus on determining the appropriate dose of PF-08046054SGN-PDL1V. Part C uses the dose found to further evaluate safety and potential effectiveness of the drug alone. Parts D and E study the combination of PF-08046054SGN-PDL1V with pembrolizumab, given intravenously, to assess safety and possible benefits. Pembrolizumab is administered at 200 mg every three weeks. Participants will undergo assessments for side effects, laboratory abnormalities, and dose-limiting toxicities over about one month initially, with follow-up for up to three years to monitor longer-term outcomes like tumor response and survival. Safety monitoring includes tracking adverse events and immune responses to the drug. The study involves regular evaluations to measure tumor changes using standard criteria and to understand how the drugs behave in the body over time.

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 as an induction therapy in people aged 16 to 80 with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart with placebo to understand its potential benefits and risks for this condition. Participants will be randomly assigned to receive either Afimkibart through an intravenous infusion followed by a subcutaneous injection, or a placebo infusion followed by Afimkibart subcutaneous injection. The study treatment is given to assess the impact on Crohns disease activity over a 12-week period. During the study, participants will have their symptoms and disease activity monitored using assessments like the Crohns Disease Activity Index CDAI, endoscopic evaluations, stool and abdominal pain tracking, and quality of life questionnaires. Safety will be closely observed up to 30 weeks after starting treatment. This study helps to measure remission rates and responses to treatment over time.

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.

Researchers are studying patients who have experienced cardiac arrest and survived after restoration of spontaneous circulation ROSC. Despite advances in care, many survivors suffer brain damage ranging from mild cognitive issues to severe vegetative states. This study focuses on exploring the interactions between the brain and heart, particularly how abnormalities in these interactions might predict neurological outcomes after cardiac arrest. The study is an observational ancillary study of the HEAVENwARd trial. The study includes patients admitted to intensive care after cardiac arrest who are in a coma and undergoing routine EEG with ECG lead recordings for neuroprognostication. It evaluates the prevalence and prognostic value of bilateral brain-heart interactions using synchronous EEG and ECG recordings. The main measurement is brain-heart interactions at day 28, with secondary outcomes including neurological outcomes, mortality, and severity of brain injury assessed by multiple markers. Participants will be monitored during their ICU stay with EEG and ECG recordings, and data will be collected to assess brain-heart coupling and neurological status. The research team will review patient outcomes at 28 days, including neurological function and survival. This study aims to improve understanding of brain-heart dysfunction after cardiac arrest and its potential role in predicting patient prognosis.

Researchers are studying adults who have experienced cardiac arrest and are admitted to intensive care while comatose. The study focuses on comparing different early brain damage scoring systems to identify which best predicts patient outcomes. This research aims to help doctors decide the best post-resuscitation treatments and provide accurate information to families. The sponsor of the study is AfterROSC. The study observes patients without assigning treatments. At intensive care unit admission, usually about 3 hours after cardiac arrest, researchers calculate early prognosis scores based on clinical and biological data. This scoring is done for all eligible patients without altering their care. The main focus is to evaluate the performance of the Cerebral Admission Hospital Prognosis CAHP score. Participants will be monitored starting from intensive care admission, with data collected on their condition and brain damage scores. Researchers use these scores to assess outcomes and compare scoring systems. The study does not specify treatment changes, focusing instead on diagnostic evaluation and prognosis. Participation involves no additional interventions beyond standard care and clinical data collection.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

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.

This research aims to evaluate the impact of close remote monitoring through a digital tool on disease control in patients with active Inflammatory Bowel Disease IBD, including Crohn Disease and Ulcerative Colitis. The study addresses current challenges in telemonitoring for chronic diseases, such as inconsistent results on disease control and quality of life. The MedicWise platform, which automatically collects various biological and healthcare data, is used to improve monitoring while reducing patient input. The trial is focused on assessing whether tight remote monitoring increases the time patients spend in remission and reduces IBD-related disability, while also analyzing effects on care team organization. Participants are divided into two groups, both using the MedicWise application to collect data. In the active telemonitoring group, alerts triggered by the application notify the care team, whereas in the control group, these alerts are inactive. Data are collected at baseline, 3, 6, 9, and 12 months. Each center determines how alerts are managed internally, without obligation to respond, with fixed alert thresholds throughout the study. Randomization is stratified by center and disease type. During the 12-month study, participants will provide data via the app and undergo regular evaluations including questionnaires on quality of life and IBD-related disability. Researchers will monitor time spent in symptomatic remission, healthcare contacts, medication adherence, complications, and satisfaction from both patients and care teams. The study aims to capture comprehensive outcomes related to disease control, quality of life, and healthcare usage over the year-long period.

Researchers are evaluating the use of liquid biopsy with ScreenCell technology to detect and measure circulating tumor cells CTCs in women during breast cancer follow-up. The study focuses on how the number of CTCs changes over time and aims to provide information on the stage and molecular characteristics of breast cancer during patient monitoring. The study involves three groups women with no cancer history confirmed by a recent negative mammogram, women with metastatic breast cancer or relapse confirmed by a positive PET scan, and women with invasive but non-metastatic breast cancer. The ScreenCell device is used on blood samples taken from participants to detect CTCs. The study is non-randomized and does not involve any masking or blinding. Participants will be followed for 9 months from enrollment to track changes in CTC levels and their molecular characteristics. Assessments include blood sample collection for CTC detection, with monitoring throughout treatment or follow-up. The primary outcome is the evolution of CTC kinetics during treatment, while secondary outcomes analyze molecular features of detected CTCs.