Plantation

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

Researchers are evaluating the effects of two different methods of giving pegloticase, a drug for uncontrolled gout, combined with methotrexate (MTX). This Phase 3 trial compares pegloticase given as an 18 mg injection under the skin every two weeks with pegloticase given as an 8 mg intravenous (IV) infusion every two weeks, both alongside weekly oral MTX. The main goal is to see which method better maintains normalized serum uric acid levels below 6 mg/dL for at least 80% of the time during the sixth month of treatment. Participants will be randomly assigned to receive pegloticase either by subcutaneous injection or intravenous infusion every two weeks, along with weekly oral doses of methotrexate. Both groups will be treated over several months while closely monitored. The study is double-blind, meaning neither participants nor researchers know which treatment is being given to maintain unbiased results. During the trial, participants will undergo regular assessments to monitor their serum uric acid levels and overall response to treatment, especially focusing on weeks 20 through 24 (Month 6). Safety and efficacy will be tracked throughout the study, including how well participants tolerate the treatments and any side effects. The study's main measure is the proportion of participants who achieve a sustained uric acid response during Month 6.

Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.

Researchers are conducting a multi-center, open-label Phase 1 clinical trial to study the drug ZG006 in adults with small cell lung cancer who have not responded to or cannot tolerate existing standard treatments. The trial aims to find the highest safe dose and recommended dose for future studies while assessing the drug's safety, tolerability, and how it behaves in the body. Participants must have a tumor tissue sample showing DLL3 expression and a performance status of 0 or 1. ZG006 will be given through an intravenous infusion. The study uses a dose escalation design called "3+3" to determine the maximum tolerated dose and recommended phase 2 dose. This process helps identify the best dose to use in further research. Participants will receive treatment and be monitored closely for side effects, laboratory changes, and adverse events over approximately two years. During the study, participants will undergo regular assessments including safety monitoring for dose-limiting toxicities, adverse events, and serious adverse events. Outcomes measured include tolerability, safety, and pharmacokinetics of ZG006. Participants will be followed for up to two years to evaluate laboratory results and overall treatment effects. Female and male participants must agree to use reliable contraception during treatment and for six months after the last dose. The total study duration depends on individual treatment and follow-up schedules.

Researchers are evaluating the safety and tolerability of NKX019, an investigational allogeneic CD19-directed CAR natural killer (CAR NK) cell therapy, in adults with active lupus nephritis or primary membranous nephropathy. This Phase 1/2 open-label, multi-center, non-randomized study also explores preliminary efficacy, pharmacokinetics, and pharmacodynamics of NKX019 in people with these autoimmune diseases. Participants have conditions that have persisted despite standard treatments and meet specific disease activity and biopsy criteria. Participants undergo a dose escalation phase using a 3+3 design to identify recommended doses. Each treatment cycle includes lymphodepletion with fludarabine and cyclophosphamide (Flu/Cy), though some may receive cyclophosphamide alone if cytopenic, followed by three doses of NKX019. The study monitors safety during and after treatment, and additional participants may be enrolled across indications once doses are established. During the study, participants receive medical evaluations including safety assessments for treatment-emergent adverse events and dose-limiting toxicities. Researchers assess disease activity, laboratory markers, and immunologic responses. Monitoring continues from the first NKX019 dose until 30 days after the last treatment. The study spans adults aged 18 to 70 years with specific autoimmune kidney diseases meeting detailed inclusion and exclusion criteria to ensure safety and appropriate participation.

Researchers are evaluating the safety and tolerability of NKX019, an investigational allogeneic CD19-directed CAR natural killer (CAR NK) cell therapy, in participants with autoimmune diseases such as systemic sclerosis, idiopathic inflammatory myopathies, and antineutrophil cytoplasmic antibody-associated vasculitis. This Phase 1/2, open-label, multi-center, non-randomized study uses a dose escalation and dose expansion design to assess preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of NKX019 in these immune-mediated conditions. The study uses a "3+3" dose escalation design to determine recommended doses for further study. Participants receive a cycle that starts with lymphodepletion using fludarabine and cyclophosphamide (Flu/Cy), or cyclophosphamide alone if they are cytopenic, followed by three doses of NKX019. The trial includes multiple cohorts to enroll additional participants across different autoimmune disease indications and monitors treatment effects and safety throughout. Participants undergo screening and receive treatments under close observation. Researchers monitor safety outcomes including dose-limiting toxicities during the first 28 days after the initial NKX019 dose and treatment-emergent adverse events from the first dose until 30 days after the last treatment. The study collects data on clinical responses, laboratory tests, and immune effects throughout the treatment and follow-up periods, with participant involvement spanning screening, treatment, and safety monitoring phases.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are evaluating the safety and tolerability of DB-1311/BNT324 in adults with advanced or metastatic solid tumors in this Phase 1/2a trial. The study includes a dose-escalation phase to find the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase to confirm safety and explore effectiveness, including in prostate cancer patients receiving novel hormone therapy. Additionally, a sub-study will assess the effects of other drugs on DB-1311's behavior in the body. During Phase 1, participants receive increasing doses of DB-1311 administered intravenously using an accelerated titration and classic 3+3 design to determine safe dosage levels. Phase 2a expands on this to further evaluate safety and tolerability, with DB-1311 given alone or combined with hormone therapy drugs such as enzalutamide or abiraterone for prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Treatment schedules and dosing details follow the study protocol at multiple centers. Participants will undergo various assessments including safety labs, vital signs, electrocardiograms, heart function tests, and performance status evaluations up to approximately one year after treatment. Researchers will monitor treatment-related toxicities, serious adverse events, and response rates. The involvement includes tumor biopsies for biomarker analysis and adherence to follow-up visits. The total study duration varies by phase, with ongoing safety and efficacy monitoring throughout.