Hutthurm

Researchers are evaluating sotatercept as a potential treatment for pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and overworking the heart. PAH symptoms include difficulty breathing and reduced ability to be active. Current standard treatments address symptoms but do not stop disease progression. This Phase 3 study focuses on the long-term safety and tolerability of sotatercept when added to standard PAH therapy. Participants in this long-term follow-up study receive sotatercept through subcutaneous injections every three weeks. Only individuals who completed prior sotatercept PAH studies without early discontinuation may join. This study continues the observation and assessment of participants over an extended period to learn about the effects and safety of sotatercept combined with background PAH treatments. During the study, participants will be regularly monitored for adverse events, treatment discontinuations, and the presence of anti-drug antibodies for up to approximately 90 months. Laboratory tests will evaluate blood components such as platelets, hemoglobin, creatinine, bilirubin, and liver enzymes. Changes from baseline in body weight, blood pressure, and electrocardiogram readings will also be tracked. The study involves adherence to visit schedules and compliance with study procedures to ensure comprehensive long-term safety data collection.

Researchers are investigating new treatments for rheumatoid arthritis (RA), a condition where current therapies like methotrexate (MTX) may not fully control symptoms for many people. This Phase 2b study evaluates a medicine called tulisokibart to see if it can better reduce RA symptoms in individuals already taking MTX. The trial aims to determine if one or more doses of tulisokibart work better than a placebo, which looks like the medicine but contains no active drug. The study includes a 12-week period where participants receive either tulisokibart or a placebo by subcutaneous injection while continuing their MTX treatment, which can be given by injection or orally. Following this, there is a long-term extension lasting 116 weeks, composed of a 44-week main extension and a 72-week optional extension, to further assess the medication's effects and safety over time. Participants will undergo assessments to measure treatment response, including the American College of Rheumatology 20% response criteria at week 12 to gauge symptom improvement. Throughout the study, researchers will monitor for safety and effectiveness, with evaluations extending through the long-term extension periods, totaling over two years of participation.

Colorectal cancer is a common and deadly cancer worldwide. Adenomatous polyps in the colon can develop into colorectal cancer, so screening and removing these polyps can help prevent the disease and related deaths. For polyps sized 5 to 19 mm, hot snare polypectomy (HSP) using electrocautery is commonly used but can cause side effects like bleeding and tissue damage. Cold snare polypectomy (CSP) has become more popular because it avoids electrocautery, making it easier and reducing adverse effects. However, there is limited and inconsistent evidence about how well CSP removes polyps sized 10 to 15 mm compared to HSP. This trial compares the complete removal rates of colorectal polyps sized 10 to 15 mm using CSP without electrocautery and HSP with electrocautery. Participants will receive one of the two procedures during colonoscopy to remove adenomatous polyps. The study aims to determine which method better achieves complete polyp removal while considering safety and technical aspects. During the study, participants will undergo colonoscopy with polyp removal by either CSP or HSP. Researchers will evaluate the rate of complete polyp resection six months after the procedure. The study involves monitoring for adverse effects and assessing the quality of polyp removal. Participants will be followed closely to measure the success of the treatment and any related complications.

This research aims to evaluate the safety and effectiveness of BMS-986504, a selective PRMT5 inhibitor, when combined with Nab-paclitaxel and Gemcitabine, compared to a placebo combined with Nab-paclitaxel and Gemcitabine. The study focuses on participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) who have a specific genetic alteration called homozygous MTAP deletion. This is a randomized Phase 2/3 trial designed to explore treatment options for this patient population. Participants will be assigned to receive either BMS-986504 at specified doses on certain days along with Nab-paclitaxel and Gemcitabine, or a placebo with the same chemotherapy drugs. The treatments are given according to protocol schedules. Some participants may have received up to one cycle of Nab-paclitaxel and Gemcitabine before starting the study treatment, provided they did not experience disease progression or intolerable side effects. The initial cycle must be completed before randomization. During the study, researchers will monitor participants for progression-free survival and overall survival for up to three years after the last participant is randomized. Assessments include measuring tumor response using established criteria (RECIST v1.1). Participants will undergo evaluations to track safety, treatment effects, and disease status throughout the trial period.

Researchers are evaluating the safety and effectiveness of two doses of inhaled pirfenidone (called AP01) compared to a placebo in people with progressive pulmonary fibrosis (PPF). This Phase 2b study is randomized, double-blind, and placebo-controlled, involving up to 300 participants who will continue their standard care during the 52-week trial. The goal is to see how well AP01 works and how safe it is when added to usual treatments for PPF. Participants will be randomly assigned to one of three groups: high-dose AP01, low-dose AP01, or placebo. All treatments are given as an oral inhalation solution twice daily. The study will last for 52 weeks, during which researchers will monitor and compare the effects of these treatments on lung function and disease progression. During the study, participants will undergo various assessments including lung function tests and clinical evaluations to track their respiratory health. Researchers will check for changes in lung capacity and symptoms and monitor safety throughout the treatment period. The main outcome measured is the impact of AP01 doses compared to placebo after 52 weeks of treatment.

Researchers are investigating treatment combinations with pelareorep and atezolizumab in patients with advanced or metastatic gastrointestinal (GI) cancers. This open-label, phase 1/2 study explores safety, potential immune-related biomarkers, and early effectiveness by measuring tumor response rates and disease control in different patient groups, including randomized and non-randomized cohorts. The study aims to understand how pelareorep may enhance the tumor environment to improve responses to checkpoint blockade therapy. Participants receive various treatments depending on their cohort, including pelareorep by 1-hour IV infusion, atezolizumab IV infusion, gemcitabine and nab-paclitaxel, oral trifluridine/tipiracil twice daily, or the mFOLFIRINOX regimen delivered by IV. Cohorts 1-4 are non-randomized while cohort 5 includes two treatment arms with randomization. If early results are promising, cohorts may expand to enroll more patients to further assess safety and potential survival benefits. During the study, participants undergo regular assessments for tumor response at week 16 and long-term follow-up for overall survival in cohort 5, lasting up to two years. Researchers monitor adverse events, perform laboratory tests, and evaluate immune biomarkers. Participants must have measurable tumors and adequate organ function and are monitored closely for safety throughout their involvement in this multi-stage clinical trial.

This research aims to evaluate the effectiveness and safety of an oral drug called ozanimod (RPC1063) in treating children and teenagers aged 2 to 17 years who have moderate to severe active ulcerative colitis (UC). These young participants have not responded well to standard treatments, and the study focuses on helping them achieve and maintain clinical remission of their condition. Participants will receive specified doses of ozanimod by mouth according to a set schedule. The study is a Phase 2/3, randomized, double-blind trial conducted at multiple centers. The goal is to assess how well ozanimod works and how safe it is in this pediatric population with UC that extends beyond the rectum. During the study, researchers will monitor participants closely through medical assessments, including endoscopy to confirm disease extent and other evaluations to track disease remission. The main outcome measured is the proportion of participants who reach clinical remission by Week 52. Safety and drug behavior in the body will also be observed throughout the trial period.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating the safety and effectiveness of BMS-986504 given alone to participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) who have a specific genetic change called homozygous MTAP deletion. This study focuses on patients whose cancer has progressed despite prior treatments and is a Phase 2 trial designed to better understand how this drug works in this specific group. Participants receive BMS-986504 at specified doses on certain days as the main treatment. This study does not mention comparison groups, and all participants receive this investigational drug to assess its impact on their cancer. During the study, researchers will monitor participants for up to three years after their last dose to see how many achieve an objective response based on standard criteria for measuring tumor shrinkage. Participants will undergo evaluations including scans and other assessments to track disease progression and treatment safety throughout the trial.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.