Izumi

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating nipocalimab to reduce the risk of fetal anemia and other serious complications in pregnancies at high risk for severe Hemolytic Disease of the Fetus and Newborn HDFN. The study compares nipocalimab to a placebo in pregnant participants to see if it can decrease risks like fetal loss, the need for intrauterine transfusions, hydrops fetalis, or neonatal death. This phase 3 trial focuses on pregnancies with maternal alloantibody presence and previous severe HDFN history. Participants receive either nipocalimab or a matching placebo through weekly intravenous infusions starting at randomization until gestational week 35. The study is randomized and triple-masked, meaning neither participants nor researchers know who receives the drug or placebo. The treatment period covers the pregnancy phase where risk is highest, with careful monitoring throughout. During the study, participants undergo various assessments including lab tests, antibody titers, fetal antigen testing, and physical exams to monitor health. Researchers track pregnancy outcomes through delivery and up to 4 weeks after birth or 41 weeks postmenstrual age for newborns. Long-term infant health, including development and complications related to HDFN, is followed for up to 104 weeks. Safety and maternal outcomes are also closely observed until 24 weeks postpartum.

Researchers are evaluating the efficacy and safety of ZL-1310 compared to Investigators Choice Therapy in adults with relapsed Small Cell Lung Cancer SCLC. This phase 3, randomized, open-label study aims to compare treatment responses and overall survival between these two therapies in participants who have previously received platinum-based systemic therapy or tarlatamab. Participants are randomly assigned to receive either ZL-1310 as a single-agent drug or Investigators Choice Therapy, which includes Topotecan, Lurbinectedin, or Amrubicin. The study follows a parallel design and monitors participants during treatment and follow-up periods lasting up to 27 months to assess various outcomes. During the study, participants undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, brain metastases response evaluations, and quality of life measurements using validated questionnaires. Safety is closely monitored by tracking treatment-emergent adverse events. Participants are expected to comply with study procedures, including tumor biopsies or providing archived tissue samples, and the total study duration may extend to nearly three years.

Crohns Disease CD is a digestive condition causing symptoms like chronic diarrhea, abdominal pain, weight loss, and fever. This research evaluates the pharmacokinetics, safety, and effectiveness of risankizumab in children aged 2 to under 18 years with moderately to severely active CD who have not responded well or cannot tolerate other treatments. Risankizumab is already approved for adults with certain inflammatory conditions and is now being studied for pediatric CD. The study includes three groups based on age, enrolling children from 2 to less than 18 years old. It has three parts an open-label 12-week induction phase where participants receive intravenous risankizumab based on their weight, a 52-week double-blind maintenance phase with subcutaneous risankizumab at one of two doses, and a 208-week open-label extension phase where treatment continues based on earlier responses. Participants who complete each phase may continue to the next, with dosing adjusted by age group. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, and questionnaires to monitor disease activity, side effects, and drug levels. Researchers will measure outcomes such as clinical remission and endoscopic response at 12 and 64 weeks, along with drug concentration in the blood. The total follow-up after treatment lasts about 140 days, with long-term monitoring during the extension phase.

Researchers are studying the safety, tolerability, and how the body processes maribavir in children and teenagers who have cytomegalovirus CMV infection after receiving a hematopoietic stem cell transplant HSCT or a solid organ transplant SOT. This phase 3 trial aims to find the best dose of maribavir using either a 200 mg tablet or a powder for oral suspension formulation. The study focuses on these young patients who have documented CMV infection and evaluates maribavirs antiviral activity along with its pharmacokinetics. Participants receive maribavir for up to 8 weeks with doses adjusted based on age and body weight. For ages 12 to less than 18 years, dosing ranges from 100 mg to 400 mg twice daily depending on weight. Those aged 6 to less than 12 years follow a similar dosing scheme, and children younger than 6 years may receive doses from 50 mg once or twice daily up to 400 mg twice daily. The medication is taken orally as tablets or powder for oral suspension during the treatment period. During the study, participants will have multiple blood tests to measure maribavir levels at various time points, and adverse events will be monitored up to 20 weeks. There is a 12-week follow-up period after treatment ends, during which participants will visit their doctor to assess continued viral control and safety. Researchers will also evaluate the clearance of CMV viremia, recurrence rates, and resistance development, along with participant feedback on medication palatability.

Researchers are investigating nerandomilast in children and adolescents aged 2 to 17 years who have fibrosing interstitial lung disease ILD. Nerandomilast has already been approved for adults with idiopathic pulmonary fibrosis, and this study aims to understand how the drug is tolerated, processed by the body, and whether it may help younger patients with ILD. The study includes both younger children and older childrenadolescents in different treatment groups to assess these questions. Participants aged 6 to 17 years are randomly placed into one of two groups one receiving nerandomilast and the other a placebo, with twice as many participants receiving nerandomilast. They take tablets twice daily for six months, then all receive nerandomilast for at least two years. Children aged 2 to 5 years receive nerandomilast from the start for at least two and a half years. The total study duration varies between two and a half and five years depending on when participants join. During the study, participants may visit the study site about 18 to 30 times. Doctors collect blood samples to monitor health and drug processing, assess lung function, growth, and quality of life, and track any changes in health. For those aged 6 to 17 years, comparisons between the nerandomilast and placebo groups help evaluate potential treatment effects. Safety and treatment-related side effects are closely monitored throughout the study period.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Ulcerative colitis UC is an inflammatory bowel disease causing inflammation and bleeding in the colon and rectum. This trial evaluates how the drug Risankizumab moves through the body and its safety and effectiveness in treating children aged 2 to under 18 years with moderate to severe UC. The study includes about 120 pediatric participants and is sponsored by AbbVie. The trial is divided into three cohorts based on age and three substudies. In Substudy 1 SS1, participants receive a weight-based dose of Risankizumab intravenously for 12 weeks. In Substudy 2 SS2, participants are randomly assigned to one of two weight-based doses of Risankizumab given by subcutaneous injection over 52 weeks in a double-blind maintenance phase. Those completing SS2 may enter Substudy 3 SS3, a 208-week open-label extension where they receive Risankizumab based on their response. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure drug levels in the blood, clinical remission, response rates, and adverse events, with follow-up lasting about 140 days after treatment. The study aims to carefully monitor the treatment effects and safety over a long period.

Researchers are evaluating the safety and effectiveness of once-weekly Somatrogon compared to daily Growth Hormone Genotropin for treating children born Small for Gestational Age SGA or with Idiopathic Short Stature ISS. This randomized, open-label study involves pre-pubertal children who have not previously received growth hormone treatment. The study is planned to last 12 months, including a screening period of up to 30 days, and aims to measure growth outcomes in these children. The study includes two groups one with 140 children with SGA and another with 114 children with ISS. Both groups will be randomly assigned to receive either Somatrogon once weekly via a subcutaneous disposable prefilled pen or Genotropin daily subcutaneous injections using commercial growth hormone delivery devices. Treatment will continue for 12 months for all participants. Participants will be involved in regular visits to assess growth through measurements such as annual height velocity, height standard deviation scores, bone maturation, and levels of Insulin-like Growth Factor-1 IGF-1. Quality of life related to health will also be evaluated before and after treatment. Monitoring includes laboratory tests and maintaining stable hormone levels. The total participation duration includes the screening and 12 months of treatment, with assessments at multiple time points throughout the study.