Bodman Ludwigshafen

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating the safety and effectiveness of combining vedolizumab with upadacitinib, called dual targeted therapy (DTT), compared to using vedolizumab alone (monotherapy) in adults with moderately to severely active Crohn's Disease. The main goal is to see if DTT better reduces bowel inflammation and ulcers after 12 weeks of treatment. This Phase 3b trial involves about 396 participants worldwide and also aims to assess the long-term safety and efficacy of these treatments. Participants are randomly assigned in equal numbers to receive either vedolizumab plus upadacitinib or vedolizumab plus placebo during a 12-week induction phase. Those who respond well, showing a significant reduction in disease activity, then continue to a 40-week maintenance phase receiving vedolizumab alone. After this, participants undergo an 18-week safety follow-up period, making the total study participation approximately 70 weeks. During the study, participants will visit the clinic 15 times for assessments including evaluations of disease activity, endoscopic examinations, and safety monitoring. The main outcome measures include the percentage of participants achieving clinical remission and showing improvement in bowel inflammation at Week 12. Researchers will track effectiveness, adverse effects, and overall health throughout the treatment and follow-up periods.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Axial spondyloarthritis (axSpA) is an immune-related inflammatory disease mainly affecting the spine, causing chronic back pain and significantly impacting quality of life with symptoms like sleep problems, social isolation, and emotional distress. This research is evaluating the real-world effectiveness of the drug upadacitinib in controlling disease activity and managing pain in adults with active axSpA in Germany. Participants will receive oral upadacitinib tablets as prescribed by their doctors before joining the study, following local guidelines on dosage and treatment. The study will last about 52 weeks, during which participants will continue their prescribed treatment and attend regular medical visits as part of routine care. Throughout the study, researchers will monitor disease activity and treatment effects using medical assessments, side effect checks, and questionnaires. The main focus is on how many participants achieve and maintain low disease activity scores over 24 and 52 weeks, assessing both clinical and patient-reported outcomes related to pain and disease burden.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System, a robotic-assisted device, for repairing nerve injuries in the hand. The study focuses on adults aged 18 to 70 years who have traumatic sensory nerve lesions in a finger nerve distal to the carpal tunnel and require nerve suturing. The main goal is to assess the recovery of sensation using the two-point discrimination test six months after the surgery, while also monitoring serious adverse events during the procedure. Participants are randomly assigned to one of two groups: one group undergoes nerve repair using the Symani Surgical System, either fully robotic-assisted or a hybrid with manual suturing, and the other group receives manual nerve repair by surgeons without robotic assistance or via a hybrid approach. The surgeries are performed according to detailed procedures for each method, ensuring either full or partial use of the robotic system or manual techniques. During the study, participants will be followed from their initial surgery through six months afterward. Researchers will evaluate sensory recovery using the two-point discrimination test and track any serious adverse events during the operation. Participants will attend follow-up visits as required, and their progress and safety will be carefully monitored throughout the study period.

Researchers are evaluating the safety and effectiveness of SAR441566 in adults with moderate to severe Crohn's Disease in this phase 2, multinational, randomized, double-blind, placebo-controlled study. The main goal is to compare different doses of SAR441566 against a placebo to see how well they work in treating Crohn's Disease. The study involves participants who have had a confirmed diagnosis of Crohn's Disease for at least three months and have shown moderate to severe symptoms. Participants will take either SAR441566 tablets or matching placebo tablets orally during the study. The study begins with a 4-week screening period, followed by a 52-week main treatment phase that includes 12 weeks of induction treatment and 40 weeks of maintenance treatment under double-blind conditions. After this, a 2-week follow-up is conducted for those not entering the long-term safety study. Eligible participants may join an open-label phase lasting up to 40 weeks, but the combined time in maintenance and open-label phases will not exceed 40 weeks. During the study, participants will undergo assessments including endoscopy to measure response at week 12. Researchers will monitor symptoms, stool frequency, and abdominal pain scores to evaluate treatment effects. Safety will be tracked throughout the study, including a follow-up after treatment ends. The total study duration for participants can be up to 59 weeks, with careful monitoring to ensure accurate evaluation of SAR441566's impact on Crohn's Disease.

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 evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.