Rishon Lezion

This trial investigates the safety, tolerability, and pharmacokinetics (PK) of OMN6 in adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by the Acinetobacter baumannii complex (ABC). It is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled study designed to find safe and well-tolerated doses of OMN6 and to measure how the drug behaves in the body of affected patients. Participants receive one-day treatment with OMN6 given as three 3-hour intravenous infusions in either 50 mg, 100 mg, or 150 mg doses three times a day. This treatment is given alongside background antimicrobial therapy with meropenem and colistin, which is continued for 7 to 14 days. A matching placebo group receives the same infusion schedule and background therapy without OMN6. During the study, researchers monitor the safety of the single-day OMN6 treatment over 28 days and assess PK measures such as the peak concentration (Cmax), time to peak concentration (Tmax), area under the curve (AUC), and half-life (t1/2) of OMN6 within one day. Patients are closely observed for side effects and treatment responses during this period to gather information on safety and drug behavior.

Researchers are evaluating the efficacy, pharmacokinetics, and safety of the drug Mirikizumab in pediatric participants aged 2 to less than 18 years who have moderately to severely active ulcerative colitis (UC). The study focuses on children who have UC lasting at least 3 months and who have not responded to treatments such as corticosteroids, biologics, immunomodulators, or JAK-Inhibitors. This is a multicenter, open-label phase 3 trial aiming to better understand how Mirikizumab works and its safety in this young population. Participants will receive Mirikizumab either intravenously (IV) or subcutaneously (SC) as part of the treatment. The study includes initial treatment and allows participants who complete the trial to enter a long-term extension study called AMAZ. This helps to further assess the drug’s effects over an extended period. The intervention involves monitoring responses after treatment, especially focusing on clinical remission by week 52 among those who responded by week 12. Throughout the study, participants will undergo various assessments to monitor their ulcerative colitis symptoms and overall health. Researchers will measure clinical remission using the modified Mayo score at week 52. Safety and drug levels in the body will also be evaluated. The study involves regular visits and monitoring to track how participants respond to Mirikizumab during the treatment and follow-up periods, providing comprehensive data on the drug’s impact in pediatric UC patients.

Researchers are evaluating the safety and effectiveness of once-weekly Somatrogon compared to daily Growth Hormone (Genotropin) in pre-pubertal children with short stature who were either born small for gestational age (SGA) or have idiopathic short stature (ISS). This is a Phase 3 randomized, open-label study that plans to enroll two groups of children: 140 with SGA and 114 with ISS, all of whom have not received prior growth hormone treatment. The study duration is 12 months, with an initial screening period of up to 30 days. Participants will be randomly assigned to receive either Somatrogon once weekly or Genotropin daily for 12 months. The study involves two parallel groups: one group for children with SGA and another for children with ISS, each split evenly between the two treatment options. The treatments are administered as growth hormone injections either weekly or daily, and the study monitors their effects over a full year. Throughout the study, children will have regular visits to monitor growth, including measuring annualized height velocity after 12 months of treatment. Assessments will include growth measurements and evaluations of safety and treatment adherence. Researchers will collect data to compare the outcomes and safety profiles of the two growth hormone regimens over the study period, supporting ongoing treatment decisions for children with short stature related to SGA or ISS.