Negrar Di Valpolicella

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

Researchers are studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

Crohn's disease is a chronic inflammatory condition of the digestive tract that cannot be cured. This research aims to evaluate how effective two approved drugs, upadacitinib and risankizumab, are as second-line treatments for adults with moderate-to-severe Crohn's Disease in real-world clinical settings. The study includes patients who have previously used a first-line treatment and now need additional therapy. Participants will be prescribed either upadacitinib or risankizumab by their doctors following routine medical practice and local guidelines. The study has a retrospective phase looking back up to 2 years before enrollment and a prospective phase lasting up to 18 months after enrollment. There are no additional procedures or burdens expected for participants beyond their usual care. During the study, researchers will track how many participants achieve remission without corticosteroids after 12 months. Participants' medical records will be reviewed, and their health monitored over time according to standard care. The total follow-up will allow assessment of the long-term effectiveness and safety of these treatments in routine practice.

Researchers are evaluating the effectiveness and safety of induction therapy with Afimkibart (RO7790121) compared to a placebo in people with moderately to severely active ulcerative colitis (UC). This Phase III, multicenter, double-blind, placebo-controlled study focuses on participants aged 16 to 80 who have an established diagnosis of UC and have shown inadequate response or intolerance to previous UC treatments. Participants will receive either Afimkibart or a matching placebo. Those assigned to the Afimkibart group will get the drug first through an intravenous (IV) infusion, followed by subcutaneous (under the skin) injections. The placebo group will receive matching IV and subcutaneous treatments that do not contain the active drug. During the study, participants will be monitored for clinical remission at 12 weeks, which is the primary outcome measure. Researchers will assess safety and response through scheduled visits and evaluations. The study includes careful tracking of participants' health status and any side effects to understand the treatment's impact over the course of the trial.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (also called RO7790121) in people aged 16 to 80 years who have moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study focuses on how well Afimkibart works compared to placebo in improving symptoms and healing the intestine. Participants will receive Afimkibart either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study includes a placebo group receiving a matching IV infusion. Treatment is given during the induction phase to assess the initial response. During the study, participants will be monitored for clinical remission using the Crohn's Disease Activity Index and for endoscopic response at 12 weeks. Researchers will assess safety, effectiveness, and any side effects throughout the study. Participants will undergo evaluations including symptom tracking and medical tests to measure treatment outcomes.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the safety and effectiveness of lutetium (177Lu) vipivotide tetraxetan (AAA617) in adult men with oligometastatic prostate cancer (OMPC) that is progressing after initial treatment to the primary tumor. This Phase III study aims to determine if AAA617 can control recurrent tumors and delay the need for androgen deprivation therapy (ADT), while preserving quality of life. The study focuses on early-stage prostate cancer patients with limited metastatic lesions that are positive for prostate-specific membrane antigen (PSMA). All participants will undergo a baseline PET/CT scan using either gallium (68Ga) gozetotide or piflufolastat (18F) to confirm PSMA-positive lesions, along with conventional imaging such as CT/MRI and bone scans. Following randomization, all metastatic lesions will receive stereotactic body radiation therapy (SBRT) over approximately 3 weeks. Participants randomized to the investigational arm will then receive up to 4 cycles of AAA617 treatment, given once every 6 weeks. Those in the observation group will end treatment after SBRT. Visits are scheduled weekly during treatment cycles and every 16 weeks afterward until disease progression, with the overall study lasting about 6.5 years. During the study, participants will have regular assessments including imaging scans, laboratory tests, and clinical evaluations to monitor disease progression and side effects. A blinded independent review committee will measure metastasis-free survival, tracking time from randomization until evidence of distant metastasis or death, for up to 30 months. Safety and quality of life will also be closely monitored throughout the study and follow-up periods.

Researchers are evaluating infection activity in travelers and migrants who have been diagnosed with chronic schistosomiasis using site-specific diagnostic methods. The study aims to determine how many of these individuals have an active infection at the time of evaluation by combining clinical, laboratory, and diagnostic test results such as microscopy, PCR, POC-CCA, and serum CAA tests. Participants diagnosed with chronic schistosomiasis will undergo a detailed baseline evaluation including blood tests for blood counts and various schistosome tests, urine tests for microscopy, hematuria, PCR, and POC-CCA, as well as stool tests for microscopy, PCR, and fecal occult blood. Organ-specific ultrasounds and other tests may be performed as decided by their physician. Serum samples will be sent to a specialized lab in the Netherlands for further CAA testing using the UCP-LF CAA assay device. Participants may also choose to allow leftover serum to be stored for 15 years for future research. Throughout the study, participants will be closely monitored for active infection at baseline using composite reference standards integrating all test results. The study collects comprehensive clinical and laboratory data to assess infection status. Participation includes signing informed consent and optional consent for serum storage. The study includes individuals aged 5 years and older with chronic schistosomiasis, excluding those with recent praziquantel treatment or acute infections.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are studying the immunity triggered by the Qdenga4 dengue vaccine in people who receive it as part of their routine care before travel. The goal is to understand both humoral (antibody) and cellular immune responses to the vaccine in vaccinees, including those with or without previous exposure to dengue or other flavivirus infections or vaccinations. This observational study is conducted at a single center and expects to enroll 402 children aged 4 years and older, as well as adults. Participants will receive the Qdenga4 vaccine and have blood samples taken at multiple times: at the first vaccine dose (T0), 24 to 48 hours after the first dose (T1), just before the second dose (T2), and one to two months after the second dose (T3). There is also the possibility of collecting an additional blood sample within two years (T4). These samples will be analyzed to characterize innate immunity, cellular immunity, and humoral responses induced by the vaccine. During the study, participants will provide blood samples at these scheduled times to help researchers measure the levels of antibodies against dengue virus before vaccination, before the second dose, and after the second dose. The study will also examine cellular immune responses and monitor the immune system's activation. Participants are followed over this period with possible extended monitoring for up to two years, allowing a detailed evaluation of the vaccine's immune effects over time.