Tustin

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are evaluating the safety and effectiveness of the FloStent, a medical device designed to treat men experiencing symptoms of Benign Prostatic Hyperplasia (BPH). This clinical study compares the FloStent to a sham procedure, which involves flexible cystoscopy without deploying the device. The purpose is to assess how well the FloStent improves urinary symptoms in men with BPH. Participants will undergo a flexible cystoscopy. Those assigned to the treatment group will have the FloStent deployed during the procedure, while those in the control group will have the cystoscopy without device deployment. The study is designed as a prospective, multicenter, double-blind, randomized trial ensuring unbiased results. During the 12-month study period, researchers will monitor changes in participants' International Prostate Symptom Score (IPSS) to measure symptom improvement. Participants must complete all study visits and protocols as part of their involvement. Safety and effectiveness outcomes will be carefully tracked throughout the trial.

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 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 insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating LBP-EC01, a recombinant bacteriophage cocktail, in a Phase 2 study for treating acute uncomplicated urinary tract infections (UTIs) caused by drug-resistant E. coli. The study includes an initial open-label pharmacokinetic phase with 30 patients to find the best dosing regimen, followed by a blinded randomized phase with 288 patients comparing LBP-EC01 plus antibiotic to placebo plus antibiotic. All participants must have active acute uncomplicated UTI at the start and a history of prior UTI caused by antimicrobial-resistant E. coli. The study has two parts: Part 1 involves three different dosing regimens of LBP-EC01 combined with oral trimethoprim/sulfamethoxazole (TMP/SMX) given over three days. These regimens include intraurethral doses on Days 1 and 2 plus intravenous doses of varying amounts and infusion methods on Days 1 through 3. Part 2 is a double-blind randomized trial using the selected dosing regimen from Part 1, comparing LBP-EC01 plus antibiotic to placebo plus antibiotic, both given orally twice daily for three days. Participants will be closely monitored through urine and blood testing to measure LBP-EC01 levels and assess symptom resolution and microbiologic response by Day 10. Study visits include sample collection, adherence to medication, and safety assessments. Female participants of childbearing potential must use effective contraception during the study and for two weeks after treatment. The study also includes a six-month follow-up period to monitor outcomes and any recurrence of infection.

Researchers are evaluating how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes who have previously been treated with basal insulin. This is a Phase 2, randomized, open-label, comparator-controlled trial focused on adults aged 18 to 70 years with type 2 diabetes. The study aims to compare the effects of these treatments on blood sugar control over time. Participants will receive either LY3938577 or degludec, both given by subcutaneous injection. The study will last about 26 weeks, during which participants will be monitored closely to assess treatment effects. The treatments are administered under controlled conditions to evaluate their impact on participants' diabetes management. During the study, participants will have their blood sugar levels monitored, including measuring the time their glucose levels remain in the target range between 70 and 180 mg/dL from baseline through week 20. Researchers will also evaluate safety and other health indicators throughout the study. Participation involves regular visits and assessments to track treatment outcomes and ensure participant well-being.

Researchers are evaluating how well nipocalimab works compared to a placebo in adults with moderate to severe systemic lupus erythematosus (SLE), a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study focused on adults aged 18 to 75 who have active SLE symptoms and have been diagnosed for at least 24 weeks. Participants will receive either nipocalimab or a placebo alongside standard of care treatments, which include protocol-defined topical and systemic therapies. Nipocalimab and placebo are administered as drugs while maintaining background treatments. The study monitors participants over time, including a primary outcome measurement at Week 52 to assess the percentage of participants achieving a systemic lupus erythematosus responder index (SRI)-4 composite response. During the study, participants will be regularly assessed for disease activity, vital signs, and safety. Screening includes physical examinations, medical history review, vital signs, and electrocardiograms. Researchers will monitor disease activity scores and evaluate response to the treatment at Week 52. Safety is closely observed throughout the study, with particular attention to any adverse reactions or changes in health status. The total participation and follow-up extend at least through Week 52.