Provincia Di Padova

Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.

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 targeted therapies and immunotherapy, alone or in combination, in people with metastatic colorectal cancer (mCRC) whose tumors show specific biomarkers. This open-label, exploratory Phase I/Ib study assigns participants to treatment groups based on their tumor biomarker test results. The goal is to understand how well these treatments work and how safe they are for different patient subgroups defined by biomarker status. Participants may receive various study drugs, including oral medications like Inavolisib, SY-5609, and Divarasib, or intravenous drugs such as Bevacizumab, Cetuximab, Atezolizumab, Tiragolumab, FOLFOX, and FOLFIRI. The specific treatment and schedule depend on the assigned study arm and the participant's biomarker profile. Biomarker testing is done using validated tests, including the FoundationOne Liquid CDx blood test, to guide treatment allocation. During the study, participants will be monitored for safety and treatment response over approximately 84 months, focusing on the objective response rate. Evaluations include tumor measurements using RECIST criteria, collection of tumor tissue samples for biomarker research, and regular assessments of organ function and overall health. Safety is closely tracked, and participants must be able to follow the study protocol and attend scheduled visits throughout their participation.

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 whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are evaluating vedolizumab, a medication designed to reduce inflammation and pain in the digestive system, in children and teenagers with moderate to severe Crohn's disease. This Phase 3 study focuses on checking whether participants achieve remission, where symptoms improve or disappear and endoscopy shows no inflammation. The study will enroll about 120 pediatric patients who have not responded to or tolerated standard Crohn's disease treatments. Participants will receive three vedolizumab infusions over six weeks during the Induction Period, with doses based on their weight. At Week 14, those showing clinical response will be randomly assigned to receive either a high or low dose of vedolizumab every eight weeks through Week 46 in the Maintenance Period. Doses are adjusted based on weight groups, and participants who worsen may have their dose increased. Treatment is given via intravenous infusion, and one-time corticosteroid rescue therapy is allowed if needed. Throughout the study, participants will be closely monitored for clinical remission using the Pediatric Crohn's Disease Activity Index and endoscopic response using colonoscopy scores at Week 54. Those not maintaining corticosteroid-free remission may have additional safety visits and enter a long-term follow-up lasting up to two years. Participants who complete the study may continue vedolizumab treatment in an extension study. Researchers will assess safety and effectiveness over the entire study period.

Researchers are evaluating the long-term safety of vedolizumab in children with ulcerative colitis (UC) or Crohn's disease (CD). This study is an extension of two previous parent studies involving pediatric patients with UC or CD. Its main goal is to collect safety data over an extended period for children who have already participated in the earlier studies. Participants who join the Treatment Cohort will receive vedolizumab intravenously at the same dose they had at Week 46 of the parent study. Dosing is based on weight categories, with treatment given every 8 weeks. The study continues until the participant withdraws, vedolizumab becomes commercially available for pediatric use in their country, other drug access programs start, the sponsor decides to close the study, or for up to approximately 5 years. Participants who are not eligible for the Treatment Cohort or who stopped early will be enrolled in an Observational Cohort to monitor safety events for up to about 2 years without receiving further vedolizumab treatment. Throughout the study, participants will be closely monitored for adverse events and specified safety outcomes. Those in the Treatment Cohort will have safety visits and assessments, including a final visit 18 weeks after their last dose. The Observational Cohort participants will be followed for up to 2 years to assess safety without additional treatment. This study aims to provide important long-term safety information for vedolizumab use in children with UC or CD.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.