Leczna

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are studying influenza in children younger than 12 years to understand how the virus changes when treated with the drug baloxavir marboxil. This study has two parts Part A monitors the presence and development of specific changes in the virus before and after treatment in pediatric patients. Part B focuses on how influenza spreads within households from treated children under 12 to their family members, though no new participants will join Part B as per the latest study update. Participants receive a single oral dose of baloxavir marboxil on the first day, with the dose based on their body weight and age. Household contacts of the treated children are enrolled for observation but do not receive the drug. The study tracks viral changes and resistance at multiple points, including baseline and several days after treatment, and monitors influenza transmission within households. Throughout the study, children will undergo various tests such as local influenza and SARS-CoV-2 testing to confirm infection status. Researchers will measure how often virus mutations associated with resistance occur, changes in viral levels, and any side effects up to 29 days. For household contacts, influenza transmission and symptom development are checked on days 6 and 10. Participation involves scheduled visits and testing to gather this information, with the study expected to continue until mid-2027.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are studying obefazimod to evaluate its effectiveness and safety as a treatment for adults with moderately to severely active Crohns disease who have not responded well or cannot tolerate conventional or advanced therapies. This Phase 2b trial compares obefazimod with a placebo to see if it can help control symptoms and improve disease activity. The study also aims to assess the long-term safety and tolerability of obefazimod during an extension period. The study includes three treatment phases a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. Participants receive one of four daily treatments obefazimod at doses of 50mg, 25mg, or 12.5mg, or a placebo. All treatments are taken once daily, ideally in the morning with food. The extension phase focuses on monitoring safety and tolerability compared to placebo. Participants will attend regular study visits for assessments including the Crohns Disease Activity Index and endoscopic scores to measure disease activity and response. Safety is monitored through adverse event reports and laboratory tests, including blood work for hematology, coagulation, and biochemistry at various weeks up to the end of the study. The total study duration spans several phases, allowing close observation of treatment effects and safety over time.

Researchers are evaluating tozorakimab as an additional treatment to standard care in adults hospitalized with viral lung infection who need supplemental oxygen. The study aims to determine if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation. This Phase III trial involves a large group of participants to assess the safety and effectiveness of this approach. Participants are randomly assigned to one of two groups one group receives a single intravenous dose of tozorakimab on the first day, while the other group receives a matching placebo. The study uses a double-blind design, meaning neither participants nor researchers know which treatment is given. This helps ensure unbiased results. The treatments are given once, and participants continue to receive standard care during the trial. During the study, participants are closely monitored and evaluated up to 60 days after treatment. Researchers track important outcomes such as death rates, progression to invasive ventilation, days alive outside intensive care, and oxygen use. They also assess clinical progression using a World Health Organization scale and monitor for any anti-drug antibodies. The trial lasts until November 2027, with multiple assessments throughout to understand the treatments impact and safety.

Researchers are conducting a multicentre phase III clinical trial involving adults and adolescents aged 12 years and older who have severe burns. The study aims to confirm the effectiveness and function of denovoSkin, an autologous dermo-epidermal skin substitute, in achieving wound closure and reducing scarring for patients with deep partial and full-thickness burns compared to the standard treatment of split-thickness skin grafts. Participants receive either the experimental treatment with denovoSkin applied to one burn area or the standard split-thickness skin graft STSG applied to another area. The study uses an intra-patient randomized design where one location is treated with denovoSkin and the other with STSG, with the roles of locations A and B switched among participants. This design allows direct comparison of the two treatments in the same patient. During the trial, participants are monitored for wound closure and scar quality six months after grafting, which is the primary outcome. Secondary outcomes include assessment of graft take, epithelialization, scar contracture, and donor site healing at various time points up to 24 months post-grafting. Participants will undergo regular evaluations to measure these outcomes and ensure safety, with the study lasting until 2029.

Researchers are investigating treatment strategies for adults with moderately to severely active Crohns disease CD. The study focuses on transmural healing TMH, a promising but not yet formal treatment target, assessed using noninvasive intestinal ultrasound IUS. The aim is to determine if treating patients to achieve corticosteroid-free IUS outcomes combined with clinical symptoms and biomarkers improves corticosteroid-free endoscopic remission better than targeting symptoms and biomarkers alone. Participants will be randomly assigned to one of two treatment groups for 48 weeks. Group 1 aims for corticosteroid-free remission based on IUS outcomes, clinical symptoms, and biomarkers, with specific IUS response assessments at weeks 22 and 30 and a final TMH target at week 38. Group 2 aims for corticosteroid-free clinical and biomarker remission without IUS targets. All participants receive vedolizumab infusions starting with an induction regimen followed by maintenance infusions every 8 weeks, with treatment adjustments at weeks 22, 30, and 38 based on target assessments. Throughout the study, participants will undergo regular assessments including IUS imaging, symptom evaluations, biomarker testing, and endoscopic scoring up to week 48 and beyond. Key measures include corticosteroid-free endoscopic remission, TMH rates, clinical remission, and biomarker responses. Safety and adverse events will be monitored, with follow-up visits extending to week 96. Participation involves adherence to study visits and treatment schedules to evaluate the impact of different treatment targets on disease activity.