South Miami

Researchers are evaluating the safety and tolerability of a study drug called MK-1403 in adults with Type 2 diabetes mellitus T2D. The study also aims to understand how MK-1403 behaves in the body over time pharmacokinetics and its effect on levels of high-sensitivity C-reactive protein hsCRP in the blood. This is a phase 1 clinical trial focused on treatment in adults aged 18 to 75 with T2D. Participants will be assigned randomly to one of four groups receiving either MK-1403 combined with an additive coformulation or a placebo combined with the same additive coformulation. These treatments are taken orally once daily, with two different dosage levels studied sequentially. The study compares the effects and safety of MK-1403 plus the additive at two different doses against placebo plus the additive at matching doses. During the study, participants will be monitored for adverse events and any discontinuation due to side effects for up to 28 days. Researchers will measure changes in hsCRP levels from baseline and examine the concentration of MK-1403 in the blood 24 hours after dosing on Day 14. The trial involves regular assessments to track safety, tolerability, and drug behavior, with the overall participation lasting approximately four weeks.

Researchers are evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and refractory autoimmune diseases such as systemic lupus erythematosus SLE with nephritis and rheumatoid arthritis RA. This phase 2, open-label, multicenter trial aims to better understand how these drugs work in these conditions and their impact on disease activity and kidney health. Participants will receive inebilizumab through intravenous IV infusions in different dosing schedules, or blinatumomab through subcutaneous SC injections at varying doses depending on the subprotocol group. The study includes several parts focusing on different autoimmune conditions and treatment regimens, with some parts no longer recruiting new participants. During the trial, participants will undergo regular assessments including monitoring for adverse events, evaluation of disease activity using specific clinical scores, kidney function tests, and antibody levels. Researchers will track safety and treatment responses over a period of up to 52 weeks, with visits occurring at scheduled intervals to collect data and monitor participant health.

Researchers are evaluating the safety profile of OviTex PRS, a reinforced tissue matrix device, in patients who have previously undergone implant-based breast reconstruction. This observational study includes both retrospective and prospective data and focuses on women aged 18 to 75 years who received either pre-pectoral or sub-pectoral breast implants using OviTex PRS. The study aims to understand overall safety and device-specific safety to help guide future studies on effectiveness. The study involves patients who had immediate or two-stage unilateral or bilateral implant-based breast reconstruction using OviTex PRS devices, either permanent or resorbable. The reconstruction could have been performed in the sub-pectoral or pre-pectoral position. This multi-center study includes patients who have completed their initial and, if applicable, exchange surgeries. Some participants may also take part in a prospective portion that includes returning for in-person visits and photograph completion. Participants will be followed for safety outcomes up to 24 months after OviTex PRS implantation. Researchers will collect data on the occurrence of relevant adverse events, time to expander or implant exchange, intraoperative fill volumes and visits, and aesthetic assessments using the Telemark Breast Score and Rainbow Scale. Hospitalization length of stay at the time of procedure will also be recorded. The study monitors participant adherence and safety throughout this period, providing important insights into the devices use in breast reconstruction.

Researchers are studying vaccines to prevent illnesses caused by Streptococcus pneumoniae bacteria, which have many different types called serotypes. This trial focuses on a new vaccine called V118E and compares it with an existing vaccine, PREVNAR 20, to learn how safe and well-tolerated V118E is in healthy adults aged 18 to 49. The study is a phase 1 trial designed to evaluate the safety, tolerability, and immune response to V118 formulation E. Participants will receive injections in a two-dose schedule. One group will get the V118E vaccine by intramuscular injection on Day 1 and Day 29. The comparison group will receive one dose of PREVNAR 20 vaccine on Day 1 and a saline injection on Day 29. Both vaccines are given by intramuscular injection, and the study is randomized and double-blind. During the study, participants will be monitored for any side effects, including injection-site reactions and other adverse events up to 12 months after the last vaccination. Researchers will also measure immune responses by checking antibody levels before and after the first vaccination. The study involves regular visits and safety assessments to understand how well participants tolerate the vaccines and to track any medical issues that may arise over the year-long follow-up period.

This research focuses on breastfeeding mothers who are receiving bimekizumab, a treatment for conditions such as moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa. The study aims to measure the amount of bimekizumab present in mature human breast milk. It is a phase 1, open-label study sponsored by UCB Biopharma SRL, designed to understand drug exposure through breastfeeding. Participants are women who continue to receive commercially available bimekizumab as prescribed by their physicians. They will be monitored while breastfeeding, with breast milk samples collected on multiple days spanning from Day 1 to Day 57. The study does not alter their treatment but observes the concentration of bimekizumab in breast milk during this sampling period. Throughout the study, researchers will collect breast milk samples on specified days to assess bimekizumab levels and estimate infant exposure. Safety will be monitored by recording any treatment-emergent adverse events in the mothers from the time of consent through follow-up. The total duration of active sampling and monitoring extends to approximately 17 weeks, during which mothers will be observed under the care of their treating physicians.

Researchers are evaluating the safety and effectiveness of different doses of ELV001 in adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study plans to enroll about 180 to 220 participants and lasts 32 weeks from screening to the end of the study. The study aims to understand how ELV001 affects disease activity scores and other health measures in this patient group. Participants are divided into four groups receiving either placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. The study includes a 4-week screening period, followed by a 12-week placebo-controlled treatment phase. After week 12, all participants receive ELV001 at 75 mg or 125 mg doses during a treatment extension lasting until week 24. This is followed by a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including disease activity scoring, joint counts, health questionnaires, blood tests, ECGs, and vital sign monitoring up to week 28. The main measurement is the change in disease activity score from baseline to week 12. Safety outcomes such as adverse events and laboratory results will be tracked up to 32 weeks. Participants will be closely monitored for response and side effects during the entire 32-week study duration.

Researchers are evaluating the safety and immune response of two new vaccines, V350A and V350B, which target the Epstein Barr virus EBV. EBV can cause infectious mononucleosis and is linked to certain cancers and multiple sclerosis. This Phase 1 trial focuses on healthy individuals aged 12 to 30 to assess how well these vaccines are tolerated and their safety profiles. Participants will be randomly assigned to receive either the V350A vaccine, the V350B vaccine, or a placebo. Each participant will get vaccinations on Day 1, Month 2, and Month 6, all given by intramuscular injection. The study uses a triple-blind design to ensure unbiased results, and it follows a sequential study model. During the trial, participants will be monitored for adverse events at the injection site and systemic reactions up to six months post-vaccination. Other safety assessments include monitoring for serious and medically attended adverse events up to eighteen months. Researchers will also measure immune responses by analyzing antibody levels against EBV over approximately eighteen months. The total participation duration extends to about eighteen months with regular safety and immune system evaluations.

Researchers are evaluating the safety and effectiveness of NEXAGON4 lufepirsen ophthalmic gel in people with persistent corneal epithelial defects PCED, a condition where the corneal surface does not heal properly. This randomized, double-masked, vehicle-controlled study aims to understand how well NEXAGON works in treating PCED and its durability after treatment. This Phase 2 trial is sponsored by Glaukos Corporation and is conducted at multiple centers. Participants will be randomly assigned to receive one of three treatments applied topically to the eye once a week for 4 to 8 weeks a high dose of lufepirsen, a low dose of lufepirsen available only at EU sites, or a vehicle gel without the active drug. After the treatment period, a 4-week follow-up will monitor the condition. If the corneal defect does not heal or the healing is not maintained for 28 days, participants may enter an open-label treatment phase with NEXAGON for an additional 8 weeks. During the study, participants will undergo screening to confirm eligibility, receive weekly treatment applications, and be monitored for safety and healing progress. Researchers will assess corneal re-epithelialization and its durability as the main outcome. The total study participation includes the screening, up to 8 weeks of treatment, 4 weeks of follow-up, and possibly an 8-week open-label extension. Safety, efficacy, and healing durability will be closely observed throughout these periods.

This research aims to evaluate the effectiveness and safety of AZD1163, a new bispecific antibody, in adults with moderately-to-severely active rheumatoid arthritis RA who are positive for anti-citrullinated peptide antibodies ACPA. The study focuses on patients who have had an inadequate or lost response or intolerance to certain standard treatments. The trial is a Phase II, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess AZD1163s impact on RA disease activity. Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a matching placebo. All participants will continue their standard care treatments, which may include conventional synthetic disease-modifying antirheumatic drugs csDMARDs or tumor necrosis factor inhibitors TNFi with or without csDMARDs. The treatment period lasts 24 weeks, followed by a 28-week safety follow-up phase. Throughout the study, participants will undergo assessments including disease activity scores such as DAS28-CRP, American College of Rheumatology response criteria ACR20 and ACR50, and clinical disease activity indexes. Researchers will also evaluate the pharmacokinetics and immunogenicity of AZD1163. Safety monitoring continues during the follow-up period, and total participation spans approximately 52 weeks.

Researchers are evaluating bimekizumab administered intravenously compared to subcutaneous injection in adults with active psoriatic arthritis or active axial spondyloarthritis. The study aims to show that the intravenous method is not less effective than the subcutaneous method by assessing how the drug moves in the body over time. This is a Phase 1, open-label, randomized, parallel-group study focused on treatment. Participants will receive one of three dosing regimens of bimekizumab during a pharmacokinetics lead-in phase and continue with the same assigned regimen during the treatment period. The dosing regimens include intravenous and subcutaneous administration of bimekizumab at specified times. Subjects are randomized into one of two experimental arms reflecting different intravenous regimens or a third arm receiving the subcutaneous regimen. During the study, participants will be monitored for steady-state trough concentration of the drug at week 16. Safety is assessed by tracking treatment-emergent adverse events, serious adverse events, and any events leading to withdrawal from the study through week 29. The study duration extends to the end of safety follow-up, with regular assessments to evaluate drug levels and participant health under medical supervision.