Marechal Thaumaturgo

Researchers are evaluating the safety and tolerability of three different dose regimens of budoprutug in adults with primary membranous nephropathy PMN who test positive for anti-PLA2R antibodies and continue to have proteinuria despite optimized RAAS inhibition. This Phase 2, open-label, multicenter study aims to assess the safety, pharmacodynamics, and early effectiveness of budoprutug, a humanized monoclonal antibody that targets CD19 to deplete specific cells through antibody-dependent cellular cytotoxicity. Participants will receive a single intravenous dose of budoprutug on Days 1, 15, 169, and 183 across three sequential dose groups. Approximately 45 subjects will be enrolled and treated with one of the three dose levels. The study includes an initial dosing period followed by extended follow-up to monitor B-cell recovery and other effects up to Week 48. During the study, participants will be closely monitored for adverse events and changes in various laboratory measures, including B cell counts, anti-PLA2R antibody levels, proteinuria, and kidney function. Researchers will evaluate safety outcomes up to Week 48 and assess pharmacokinetics such as plasma concentration and clearance. Follow-up visits will track participant health, treatment effects, and recovery over the course of the study.

Researchers are evaluating the antiviral effects of various treatments in adults aged 18 to 60 with early symptomatic influenza. This phase 2, multi-centre, adaptive platform trial compares several licensed influenza antiviral drugs and others with potential activity against the virus. The study aims to provide clear comparisons of antiviral activity to help guide treatment decisions and policy development. Participants may receive one of several antiviral drugs such as oseltamivir, favipiravir, zanamivir, baloxavir, molnupiravir, peramivir, laninamivir, or combinations of these medications. There is also a control group that receives no antiviral treatment except paracetamol for fever. Dosages and administration routes vary by drug and include oral, inhaled, and intravenous methods. The trial uses randomization to assign treatments, with at least 20% of participants assigned to the no treatment group. During the first five days, researchers will monitor the rate of viral clearance to assess antiviral activity. Additional measures include symptom relief and fever duration over 14 days. Participants will be closely followed up, with assessments including rapid antigen or PCR tests for influenza, symptom tracking, and safety monitoring. The total study period covers initial treatment and observation up to two weeks after starting treatment.

This research aims to evaluate the effectiveness and safety of zanidatamab combined with a physicians choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer who have either progressed on or cannot tolerate previous trastuzumab deruxtecan T-DXd treatment. Zanidatamab has shown promising results against various HER2-positive advanced tumors, including metastatic breast cancer, and may serve as a potential treatment option for these patients. The study also investigates patient-reported tolerability and physical functioning, as well as the pharmacokinetics and immune response to zanidatamab with chemotherapy. Participants will be randomly assigned to receive either zanidatamab or trastuzumab, each given by intravenous infusion alongside one of several chemotherapy options chosen by the physician eribulin, vinorelbine, gemcitabine, or capecitabine the latter is taken orally. Treatment will be administered according to the assigned group, and the study is open-label and multicenter, designed to compare these two treatment combinations in this patient population. During the study, participants will undergo regular assessments to monitor disease progression using imaging criteria RECIST version 1.1, evaluate survival, treatment response, and duration of response. Safety and side effects will be tracked through adverse event reporting and patient questionnaires on symptoms and physical function. Blood samples will be collected to study drug levels and immune reactions. Participants will be followed until disease progression, death, or for up to approximately 44 months for key outcomes, with overall survival monitored for up to about 80 months.

Researchers are studying the effect of Debio 4126, a 12-week extended-release octreotide injection, in maintaining insulin-like growth factor 1 IGF-1 levels at or below the upper limit of normal in patients with acromegaly who have previously been treated with somatostatin analogs. This Phase 3 randomized trial compares Debio 4126 to a placebo during a double-blind period to evaluate its efficacy and safety. Participants in the double-blind period receive intramuscular injections of either Debio 4126 or placebo every 12 weeks for 36 weeks, totaling three injections. Those whose IGF-1 levels remain at or below the upper limit of normal at Week 34 may enter an open-label phase receiving Debio 4126 injections every 12 weeks for an additional 24 to 60 weeks. Rescue medication is allowed for participants whose acromegaly is not well controlled during specified times. Throughout the study, participants undergo evaluations of IGF-1 levels, growth hormone levels, and treatment tolerability, including assessments of injection site reactions and adverse events. The primary outcome is the percentage of participants with IGF-1 levels at or below the upper limit of normal at 36 weeks. Safety and efficacy measures continue for up to 108 weeks, with ongoing monitoring of medication levels and rescue treatment use.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

This research investigates the effectiveness and safety of tisagenlecleucel therapy in patients with B-cell malignancies in Brazil. It includes both children and adults with relapsed or refractory B-cell acute lymphoblastic leukemia, diffuse large B-cell lymphoma, or follicular lymphoma. The study is prospective and observational, aiming to collect long-term data over up to 15 years after treatment to understand outcomes in real-world settings. Participants include pediatric patients under 18 years with B-cell acute lymphoblastic leukemia, young adults aged 18-25 with the same diagnosis, and adults 18 or older with diffuse large B-cell lymphoma or follicular lymphoma. All patients have received tisagenlecleucel therapy either commercially or as out-of-specification use. The study does not involve administering treatment or mandating questionnaires instead, it monitors patients before and after infusion to gather comprehensive data. Participants information will be collected from diagnosis through to years after infusion, including response rates, survival, and safety events. Researchers will track overall response, relapse-free survival, and other health outcomes up to 15 years. Data will include retrospective and prospective information until death or last visit. Safety events, pregnancy rates, and secondary malignancies will also be monitored throughout the study period.

Researchers are evaluating antiviral treatments for adults with early symptomatic COVID-19 who have high viral loads but are at low risk of severe illness. This Phase 2 trial aims to develop and validate a way to measure how well these treatments reduce the amount of virus in the body. The study compares three types of interventionssmall molecule drugs, monoclonal antibodies, and dose adjustments for nirmatrelvirritonaviragainst a control group that receives no antiviral treatment. The trial is adaptive and is supported by the Wellcome Trust through the COVID-19 Therapeutics Accelerator. The treatments studied include various small molecule drugs like nitazoxanide, nirmatrelvirritonavir, hydroxychloroquine, atilotrelvirritonavir, metformin, and monoclonal antibodies such as sotrovimab and others as they become available. Some treatment arms have been closed after meeting stopping criteria. Participants are randomly assigned to receive one of the available antiviral drugs or no treatment, with at least 20% assigned to the control group. Dosages vary by drug and are typically administered over 5 to 7 days. Participants will be monitored closely over the first 14 days, with daily assessments of viral levels and symptoms. Researchers will measure how quickly the virus clears from the body compared to no treatment or positive control arms. Additional outcomes include fever resolution and symptom improvement. Participants must be able to walk unaided and agree to follow-up visits. The study runs until January 2027 and aims to determine optimal dosing and antiviral effectiveness in early COVID-19 infection.

Researchers are exploring the effects of early intensive antiretroviral therapy ART, with or without broadly neutralizing antibodies bNAbs, on achieving HIV remission in infants living with HIV. The study includes two groups infants born to mothers with presumed or confirmed HIV infection who received little or no antiretrovirals during pregnancy, and infants diagnosed with HIV within 48 hours of birth who start ART early. This study is a Phase III proof of concept trial aiming to evaluate treatment strategies that may reduce HIV RNA to undetectable levels in infants. The trial assesses seven different intensive therapy regimens combining two nucleoside reverse transcriptase inhibitors NRTIs with other drugs such as nevirapine NVP, lopinavirritonavir LPVr, raltegravir RAL, dolutegravir DTG, and monoclonal antibodies like VRC01 and VRC07-523LS. Participants receive these regimens based on their cohort and specific treatment plan. The study is conducted in four steps initial evaluation and treatment initiation within 48 hours of birth, ongoing treatment for up to 192 weeks with assessments for viral suppression, possible analytic treatment interruption with close monitoring for viral rebound, and re-initiation of ART with monitoring until five years of age or six months after viral suppression. Participants are closely monitored throughout the study with HIV testing, safety assessments, and adherence evaluations. Researchers measure outcomes such as the number of participants achieving HIV remission by Week 48, viral suppression rates, eligibility and response to treatment interruption, and adverse events related to the study treatments. Safety monitoring continues during treatment interruption and after re-treatment. The total participation duration can extend up to five years to assess long-term effects and viral control.