Galveston

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 investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating the safety and immune response of OCU500, a next-generation COVID-19 booster vaccine delivered through intranasal and inhaled routes. This phase 1 randomized, open-label, dose-escalation trial involves healthy adults aged 18 to 64 who have completed a primary COVID-19 vaccination series and received at least one booster. The study assesses two dose levels of OCU500, a chimpanzee adenovirus-vectored vaccine encoding the spike protein from the Omicron XBB1.5 strain, to understand its safety and reactogenicity in previously vaccinated individuals. The trial includes 80 participants divided into four groups of 20 each, receiving either a low or high dose (1x10^10 or 5x10^10 viral particles) of OCU500 administered via intranasal or inhalational routes. Participants receive a single dose of the vaccine, with the study designed to monitor the effects of each dose level and administration method. The open-label design allows researchers to observe responses over time, including laboratory safety markers and immune responses. Participants will be closely monitored through several assessments including clinical safety laboratory tests, tracking of adverse events (local, systemic, and unsolicited), and evaluation of immune responses such as systemic anti-Spike antibodies and nasal mucosal Immunoglobulin A and G. Safety monitoring extends through six months after vaccination to capture any serious or medically attended adverse events, as well as new chronic medical conditions. The total study duration accommodates detailed follow-up and sample collection for secondary research purposes.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating the effectiveness of nipocalimab compared to a placebo in reducing the risk of fetal anemia in pregnant participants at risk for severe Hemolytic Disease of the Fetus and Newborn (HDFN). This Phase 3 study focuses on pregnancies with a history of severe HDFN and aims to improve outcomes for live neonates by addressing complications related to red blood cell volume during fetal development. Participants will receive either nipocalimab or a placebo through intravenous infusions. The study monitors the effects of these treatments on reducing fetal anemia and related severe outcomes such as fetal loss, intrauterine transfusion, hydrops fetalis, or neonatal death. Treatment is given during pregnancy, with careful tracking of maternal and fetal health. During the study, participants will undergo lab tests, physical exams, and monitoring of vital signs and heart activity. Researchers will assess the percentage of pregnancies that avoid adverse outcomes from randomization through the neonatal period, up to 4 weeks of age or 41 weeks postmenstrual age. Safety and efficacy will be closely observed throughout the study period.

Researchers are evaluating the effectiveness and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT) in pregnant women. This phase 3 study focuses on pregnancies at risk of FNAIT, a condition where the mother's immune system attacks fetal platelets, potentially leading to serious bleeding complications in the fetus or newborn. Participants will receive either nipocalimab or intravenous immunoglobulin (IVIG), both administered intravenously. Additionally, prednisone will be given orally. The study includes careful monitoring and treatment during pregnancy to assess how well these therapies work in preventing severe outcomes related to FNAIT. During the study, participants will be closely monitored through physical exams, medical history reviews, vital signs, ECGs, and lab tests. Researchers will also track the health of the fetus and newborn, focusing on outcomes such as death, severe bleeding, or low platelet counts up to one week after birth. The study requires ongoing follow-up and adherence to treatment protocols until the last visit, ensuring thorough evaluation of safety and treatment effects.

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

Researchers are investigating new vaccines to protect against illnesses caused by Streptococcus pneumoniae bacteria, which has many different types called serotypes. Vaccines include small parts of certain serotypes that do not cause infection but help the body develop antibodies to fight the bacteria. This study focuses on a new vaccine called V118E and aims to assess its safety and how well healthy adults tolerate it. Participants will receive injections through the muscle (intramuscular administration) of either the V118E vaccine, the PREVNAR 20™ vaccine, or a saline solution. The study is randomized and double-blind, meaning neither participants nor researchers know which treatment is given, to fairly evaluate safety and immune response. This is a Phase 1 trial involving healthy adults aged 18 to 49 years. During the study, researchers will monitor participants for various side effects including injection-site and systemic reactions up to 7 days after vaccination, immediate reactions within 30 minutes, and other adverse events for up to 28 days. Serious or medically attended adverse events and events of special interest will be followed for up to 12 months after the final vaccination. The study aims to gather detailed safety and tolerability data over this period.

Researchers are evaluating the use of Sulbactam-Durlobactam (SUL-DUR) in pediatric patients from birth to under 18 years old who have confirmed or suspected Acinetobacter baumannii-calcoaceticus complex (ABC) infections. The study aims to collect pharmacokinetic (PK) and safety data to determine appropriate dosing regimens in this population. This is an open-label, phase 1b study conducted in hospitalized children requiring systemic antibiotic therapy for ABC infection. Participants receive Sulbactam and Durlobactam administered intravenously in varying doses and schedules depending on their age and weight. Dosage groups include 20mg/kg or 25mg/kg of each drug given every 6, 8, or 12 hours. The treatment period involves careful monitoring of drug levels and safety. The goal is to understand drug concentration over time to guide dosing. During the study, participants undergo assessments to monitor pharmacokinetics including maximum drug concentration and total drug exposure over 24 hours on Days 1 and 3. Safety and tolerability are closely observed throughout hospitalization. The study includes detailed laboratory tests and clinical evaluations to track infection status and organ function. Participant involvement lasts through the treatment and monitoring periods as specified in the protocol.

Researchers are evaluating the effectiveness and safety of induction therapy with Afimkibart (RO7790121) compared to a placebo in people with moderately to severely active ulcerative colitis (UC). This Phase III, multicenter, double-blind, placebo-controlled study focuses on participants aged 16 to 80 who have an established diagnosis of UC and have shown inadequate response or intolerance to previous UC treatments. Participants will receive either Afimkibart or a matching placebo. Those assigned to the Afimkibart group will get the drug first through an intravenous (IV) infusion, followed by subcutaneous (under the skin) injections. The placebo group will receive matching IV and subcutaneous treatments that do not contain the active drug. During the study, participants will be monitored for clinical remission at 12 weeks, which is the primary outcome measure. Researchers will assess safety and response through scheduled visits and evaluations. The study includes careful tracking of participants' health status and any side effects to understand the treatment's impact over the course of the trial.