South Miami

This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be given access to ediary in which they will be required to self report symptoms of IBS-C daily. Information in ediary will also be used to determine eligibility prior to enrollment. During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored. Patients will return for study visit every weeks (Visits 3-6) and will undergo safety assessments as per the protocol. At the end of this 4 week period, subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period. The study plans to enroll up to 6 cohorts of eligible patients sequentially, starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks. Subsequent cohorts will assess increasing tenapanor doses, following a dose escalation order. The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol.

Researchers are studying a new oral weight loss medicine called MK-4082 in healthy adults who are overweight or obese. This Phase 1 study aims to find a safe dose and understand how the medicine behaves in the body over time. The focus is on whether people tolerate MK-4082 and its safety compared to a placebo. Participants will receive MK-4082 or a placebo in tablet form. The study uses multiple ascending doses to evaluate different levels of the medicine. The goal is to identify a dose that is safe and well tolerated for use in future research. During the study, researchers will monitor participants for any adverse events and whether anyone stops treatment due to side effects. The safety monitoring lasts up to about 98 days for adverse events and 84 days for treatment discontinuation. Participants' health and tolerability of the medication will be closely observed throughout the study period.

Researchers are evaluating the safety, tolerability, and effectiveness of two treatments, inebilizumab and blinatumomab, in adults with active and difficult-to-treat autoimmune diseases. This includes systemic lupus erythematosus (SLE) with nephritis, SLE with and without nephritis, and active refractory rheumatoid arthritis (RA). The study is a Phase 2, open-label, multicenter platform trial designed to assess these treatments across different subprotocols based on the specific condition and disease activity. Participants receive inebilizumab through intravenous infusion or blinatumomab via subcutaneous injection, depending on their assigned subprotocol. The study includes several parts: Subprotocol A focuses on SLE with nephritis treated with inebilizumab; Subprotocol B Part A and Part B assess blinatumomab in SLE with and without nephritis; and Subprotocol C Parts A and B evaluate blinatumomab in rheumatoid arthritis. The treatments are administered over specified periods, with some groups receiving treatment for up to 52 weeks. During the trial, participants undergo various assessments to monitor safety and disease response, including evaluation of treatment-emergent adverse events, serious adverse events, and measures of disease remission or activity. For example, kidney response and remission in SLE and disease activity scores in RA are measured at specific time points. Safety monitoring continues through the treatment period, with data collected on adverse events from Day 1 to Week 52. Participants' health status, laboratory tests, and disease activity are regularly evaluated to understand the treatments' effects and tolerability.

Researchers are evaluating the safety of OviTex PRS, a reinforced tissue matrix used in implant-based breast reconstruction surgeries, in women aged 18 to 75 years. This observational study looks at patients who previously received either permanent or resorbable OviTex PRS devices during immediate or two-stage unilateral or bilateral breast reconstructions, placed either above or below the chest muscle. The goal is to understand the safety profile of these devices and help guide future studies on their effectiveness. Participants in the study had undergone breast reconstruction surgery using OviTex PRS combined with implants, either permanent or resorbable types. The procedures included initial surgeries and any necessary exchange surgeries. The study collects data retrospectively and prospectively across multiple centers to assess outcomes related to the use of these devices. During the study, researchers track any significant adverse events within 24 months after implantation of the OviTex PRS device. Participants may be asked to return for follow-up visits, including photographic documentation. The study focuses on monitoring safety outcomes over two years, ensuring patients' recovery and device performance are carefully observed.

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.

This research aims to measure the concentration of bimekizumab in mature breast milk from mothers being treated with the drug. The study focuses on women who have moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, or hidradenitis suppurativa. It is a phase 1, multicenter, open-label, prospective study conducted to understand the presence of this medication in breast milk during breastfeeding. Participants in this study will be receiving bimekizumab under the care of their treating physician, following approved local prescribing guidelines. The study observes mothers who are breastfeeding and on bimekizumab treatment for at least 12 weeks after delivery. Breast milk samples will be collected on multiple days, specifically Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29, and 57 to assess the bimekizumab concentration. During the study, breastfeeding mothers will provide breast milk samples on the scheduled days, allowing researchers to monitor the drug levels over time. The primary outcome is the concentration of bimekizumab in the breast milk at each of these time points. Safety and eligibility are monitored throughout, including assessments of both mother and infant health. The total duration of participation covers the sampling period up to Day 57 after starting the study measurements.

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of different doses of ELV001 in treating active rheumatoid arthritis (RA) in patients who have not responded well to methotrexate and tumor necrosis factor inhibitors. The trial plans to enroll around 180 to 220 adult participants aged 18 to 75 years with active RA meeting specific clinical criteria. The study aims to measure changes in disease activity using the DAS28-C-reactive protein score from baseline to week 12. The study includes four groups receiving placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. Participants receive treatment for 24 weeks, starting with a 4-week screening period. The first 12 weeks are double-blind and placebo-controlled, followed by a treatment extension from weeks 12 to 24 where some participants may have their ELV001 dose adjusted. After treatment, a 4-week safety follow-up period monitors participants for any adverse effects. Participants will have regular assessments including blood tests, joint evaluations, and monitoring of disease activity scores throughout the study. Researchers will track medication adherence and safety through physical exams, laboratory tests, and ECGs. The primary outcome focuses on improvement in disease activity at week 12. The total study duration for each participant is about 32 weeks from screening to the end-of-study visit.

Researchers are investigating the safety and effectiveness of NEXAGON® (lufepirsen ophthalmic gel) for people with persistent corneal epithelial defects (PCED) that do not heal with standard treatments. This randomized, multicenter, double-masked, vehicle-controlled Phase 2 study aims to see if NEXAGON can help heal these persistent eye wounds and maintain healing over time. Participants will be randomly assigned to receive either a high dose or low dose of lufepirsen gel or a matching vehicle gel without the active drug. The study includes a Screening Period, followed by a Treatment Period lasting up to 8 weeks, and a 4-week Follow-up Period. If a participant's corneal defect does not heal or if the healing is not durable for 28 days after treatment, they may enter an additional 8-week Open-label Treatment Period with NEXAGON. During the study, participants will be monitored for corneal healing and safety. Researchers will assess whether the corneal epithelium has re-formed and maintained healing for 28 days. Evaluations will include clinical exams and monitoring for any side effects. The total study participation may last up to several months depending on healing and treatment response.

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.

This research aims to compare two ways of giving the drug bimekizumab to adults with active psoriatic arthritis or active axial spondyloarthritis. The study focuses on whether giving bimekizumab through an intravenous (IV) injection is not worse than giving it as a subcutaneous (under the skin) injection. The trial is designed as an open-label, randomized, parallel-group, noninferiority phase 1 study to evaluate how the drug moves and stays in the body over time. Participants will receive bimekizumab at scheduled times either through one of two intravenous regimens or a subcutaneous regimen. Each group will follow a specific dosing plan to see how the drug behaves in the body depending on the method of administration. The study treatments are given at pre-set time points, and the goal is to measure drug concentrations in the blood. During the study, participants will be monitored and assessed for the drug concentration in their blood at week 16 to understand steady-state trough levels. Researchers will also check for safety and tolerability throughout the study. The total duration and further assessments are not specified, but the focus is on comparing the drug levels and safety between the different administration methods in adults with these active conditions.