Modena

Researchers are evaluating how well symphysis fundal height SFH measurements alone compare to SFH combined with point of care ultrasound POC-US measuring fetal abdominal circumference AC for detecting small or large for gestational age infants among low-risk pregnant women after 35 weeks gestation. The study aims to improve prenatal identification of abnormal fetal growth, which is linked to risks for mother and baby. This open-label, randomized trial is investigator-sponsored and focuses on low-risk pregnancies managed by midwives. Participants are randomly assigned to one of two groups one group will have fetal growth monitored using SFH measurements alone, while the other will have SFH plus POC-US to measure fetal AC and assess amniotic fluid volume. Measurements occur at scheduled antenatal visits at 35-38, 40, 41, and beyond 41 weeks gestation. If screening suggests abnormal growth or amniotic fluid levels, a formal obstetric ultrasound by a specialist will be performed. All women will have POC-US at 41 and 41 weeks to check amniotic fluid, regardless of group. During the study, midwives will review medical histories, conduct physical measurements, and perform ultrasound assessments following the assigned method. Researchers will compare prenatal screening results to actual birth weights to identify small or large infants. They will also track the number of formal ultrasounds requested, cases of abnormal amniotic fluid, and maternal and neonatal outcomes. Participation lasts from enrollment at 35-38 weeks through delivery and initial postnatal assessment, about one year on average.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a condition characterized by skin thickening and other systemic symptoms. This Phase 2 study compares ianalumab to a placebo to understand its impact on this disease, aiming to provide new treatment options for affected individuals. The study is sponsored by Novartis Pharmaceuticals and employs a randomized, double-blind design to ensure reliable results. Participants receive either ianalumab or placebo through subcutaneous injections during the initial 52-week treatment period. After this, all participants enter a second 52-week open-label phase where they receive ianalumab. Following treatment, there is a post-treatment follow-up lasting at least 20 weeks and up to 2 years to monitor long-term effects. The study includes a screening period lasting up to 6 weeks before treatment begins. Throughout the study, participants undergo regular assessments including measuring response based on the rCRISS25 scale at Week 52, lung function tests, skin scoring, and disability index evaluations. Blood samples are taken periodically to measure drug levels and antibodies. Safety is closely monitored through adverse event reporting up to Week 208. The total participation time can extend over several years including treatment and follow-up phases.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

This research aims to evaluate elafibranor, a study drug, compared to a placebo in adults with Primary Biliary Cholangitis PBC and cirrhosis, a liver disease causing bile duct damage and scarring. The trial focuses on whether elafibranor can better prevent worsening of the disease, including progression leading to liver transplant or death, and also assesses long-term safety and symptom impact such as itching and tiredness. Participants will be randomly assigned to take either an 80 mg tablet of elafibranor or a matching placebo tablet once daily, orally, with or without food. This double-blind treatment period can last up to 3.5 years for each participant, with tablets taken at approximately the same time each morning. The study is designed to compare these two groups over the long term. During the study, participants will undergo regular assessments including physical exams, vital signs, electrocardiograms, laboratory tests, and symptom questionnaires at intervals up to 3.5 years. Researchers will measure liver function tests, symptom scales, liver stiffness, and clinical outcomes related to disease progression. Safety is monitored through adverse event tracking and laboratory parameters, with follow-up extending to four weeks after the last dose. Overall participation may last up to 3.5 years.

Researchers are evaluating the safety and effects of a medicine called fosmanogepix for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida yeast. This Phase 3 clinical trial compares fosmanogepix to the standard treatment using caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard treatment by a margin of 15%. The study includes adult patients diagnosed with these infections and is sponsored by Basilea Pharmaceutica. Participants are randomly assigned to one of two groups two-thirds receive fosmanogepix intravenously, with an option to switch to oral tablets, while one-third receive caspofungin intravenously followed by oral fluconazole. Matching placebos are given to maintain blinding. Treatments are given daily, first by IV infusion at the clinic and then orally either at the clinic or at home if discharged. Treatment duration can be up to six weeks, depending on infection clearance and symptom improvement. Participants will be monitored through multiple study visits, with assessments including survival status at 30 days, treatment success at the end of treatment, and follow-up evaluations six weeks after stopping treatment. Additional evaluations include clinical and mycological responses, blood cultures, safety monitoring such as adverse events, lab tests, neurological exams, ECGs, and drug concentration measurements. The total study duration for each participant may be approximately 12.5 weeks, considering treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of fosmanogepix, given either intravenously or orally, for treating adult patients diagnosed with invasive mold infections. This Phase 3 trial compares fosmanogepix to the standard antifungal therapies. The study mainly aims to assess all-cause mortality by Day 42 and includes patients both receiving primary therapy and those receiving salvage treatment after prior therapies failed or were not tolerated. Participants are assigned to one of two cohorts Cohort A, where patients receive either fosmanogepix or the best available standard antifungal treatment, and Cohort B, where patients receive only fosmanogepix as salvage therapy. Fosmanogepix is administered via IV infusion or oral tablets. The treatment phase targets 84 days but can be extended up to 180 days, followed by a follow-up period. During the study, participants undergo various assessments including mortality evaluation at Day 42, clinical and radiological response checks, laboratory tests, neurological exams, ECG monitoring, and plasma drug level measurements at multiple time points. Safety is closely monitored throughout the study and follow-up, which together may last approximately 8 months. Researchers will track adverse events and overall treatment success over this period.

Researchers are evaluating AZD8205, a new antibody drug conjugate, as a possible treatment for advanced or metastatic solid tumors including breast cancer, biliary tract cancer, ovarian, endometrial, and squamous non-small cell lung cancers. This Phase IIIa multi-center, open-label study aims to determine the safety, tolerability, and appropriate dosing of AZD8205 alone or combined with other anticancer agents such as rilvegostomig, saruparib, and AZD9574. The study includes dose escalation and expansion parts to assess anti-tumor activity in select solid tumors. Participants are assigned to one of four sub-studies that involve different combinations of AZD8205 with other drugs. Each sub-study has two parts Part A focuses on dose escalation to find safe doses, and Part B evaluates the anti-tumor effects at the recommended doses. Some sub-studies may add triplet combinations based on safety data and may include future protocol amendments. Treatment is given according to the assigned sub-study and dosing schedules. During the study, participants undergo assessments including monitoring for adverse events, serious adverse events, dose-limiting toxicities, and changes in laboratory tests, ECGs, and vital signs. Researchers also measure responses such as objective response rate, duration of response, progression-free survival, disease control rate, overall survival, pharmacokinetics, and immunogenicity over approximately two years. Study participation includes regular visits for treatment and evaluations, with safety follow-up until 30 days after the last dose.

Researchers are evaluating AZD8965 in a Phase IIb trial to study its safety, tolerability, and effectiveness in treating Idiopathic Pulmonary Fibrosis IPF. The study compares three doses of AZD8965 to a placebo in participants with IPF, including those who are on stable doses of approved antifibrotic therapies such as nintedanib, pirfenidone, or nerandomilast, as well as those not taking antifibrotic treatment. The trial is randomized, placebo-controlled, double-blind, and parallel-group in design. Participants are assigned to one of four groups placebo, low dose AZD8965, medium dose AZD8965, or high dose AZD8965. The treatment lasts for 24 weeks, during which participants receive their assigned medication. The study includes approximately 360 participants across around 200 sites worldwide. Researchers aim to assess the clinical efficacy of AZD8965 by measuring changes in lung function and study the relationship between dose and outcomes. During the study, participants will undergo various assessments including lung function tests such as forced vital capacity FVC, monitoring for adverse events, and pharmacokinetic analyses of AZD8965. Safety and tolerability are monitored up to 25 weeks. Researchers will also track any serious adverse events and treatment discontinuations. The total participation time covers the 24-week treatment period with scheduled visits to assess the study outcomes and participant health.