Coral Springs

Researchers are evaluating the effect of providing access to two types of heated tobacco products HTP on smoking reduction and abstinence among healthy adult smokers aged 21 to 65 years in the United States. This multi-site, open-label study aims to assess how using HTP devices with different flavored stick variants influences smokers ability to stop or reduce combustible cigarette use over a 3-month period. The primary goal is to measure the rate of complete cigarette abstinence in the final seven days of the study. Participants are randomly assigned to one of two study groups one using a one-piece HTP device and the other using a two-piece HTP device. Each device group includes access to four stick variantstwo menthol and two tobacco flavorsunder the brand name virto. The study includes a 90-day actual use period where participants try all four stick variants during a 1-week product trial and then continue use as they choose. The interventions are designed to explore the impact of these devices and flavors on cigarette smoking habits. Throughout the study, participants complete questionnaires via a smartphone app and undergo assessments related to cigarette use and product preferences. Researchers track cigarette reduction, switching to HTP use, time to abstinence, and adverse events over the 3-month period. The primary outcome is self-reported abstinence from combustible cigarettes in the last 7 days of the study. Secondary measures include reduction in cigarette use by at least 50%, complete switching to HTP, and safety monitoring. The total study duration spans up to 3 months with ongoing data collection and follow-up.

Researchers are evaluating PRT12396, an investigational oral drug, in participants with high-risk polycythemia vera PV and myelofibrosis MF through a first-in-human, open-label, multi-center Phase 1 study. The study aims to assess the safety, tolerability, pharmacokinetics, and early effects of PRT12396 while determining the maximum tolerated dose and recommended dose for further study. Participants include those diagnosed with PV or MF, including specific subtypes with evidence of disease burden such as splenomegaly. The study is divided into two parts a dose-escalation phase where increasing oral doses of PRT12396 are given twice daily to evaluate safety and identify the best dose levels, followed by a dose-expansion phase where additional participants receive the recommended dose to further assess safety and early efficacy. Capsules are taken twice daily, swallowed whole with water, and may be taken one hour before or two hours after meals. Participants will be involved for an average of about two years, during which researchers will monitor dose-limiting toxicities, adverse events, dose modifications, and pharmacokinetic measures such as blood drug concentration. Other assessments include blood counts, spleen size, symptom scores, and patient global impressions of change. Safety and response outcomes will be tracked throughout the study to guide future research and treatment options.

Researchers are evaluating the safety and tolerability of DB-1303BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 12a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts an initial dose-escalation phase using an accelerated titration followed by a classic 33 design to find the maximum tolerated dose MTD or recommended Phase 2 dose RP2D, and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303BNT323 by intravenous infusion once every three weeks Q3W at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

Researchers are studying the treatment of accelerated or blast phase Philadelphia chromosome-negative myeloproliferative neoplasms MPNs, a type of blood cancer, by comparing two drug regimens. This phase II trial evaluates whether combining ASTX727, which includes the drugs cedazuridine and decitabine, with iadademstat is more effective than ASTX727 alone. ASTX727 works by helping bone marrow produce normal blood cells and attacking abnormal ones, while iadademstat may stop tumor growth by blocking enzymes needed for cell growth. Patients are randomly assigned to one of two treatment groups. One group takes ASTX727 orally once daily for five days in a 28-day cycle. The other group takes ASTX727 on the same schedule plus iadademstat orally on days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle. Treatment cycles continue unless the disease progresses or side effects are unacceptable. During the study, patients provide buccal swabs, blood samples, and bone marrow samples for analysis. Participants are monitored throughout treatment with various tests including blood and bone marrow examinations. After stopping treatment for reasons other than disease progression, patients have follow-up visits every three months if they stop due to progression, follow-up occurs every six months. Researchers measure the rate of complete acute leukemia response within four treatment cycles and track event-free survival, overall survival, and stem cell transplantation rates over up to two years.

Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with Major Depressive Disorder MDD. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo in adults with moderate-to-severe MDD. Participants are adults aged 18 to 74 years with a current major depressive episode lasting between 6 weeks and 24 months. Participants will be randomly assigned to receive either azetukalner 20 mg or placebo, both taken orally once daily with food, preferably with the evening meal, for 6 weeks. The study uses a parallel design and includes a placebo comparator. Azetukalner and placebo are administered as daily oral doses over the treatment period. During the study, participants will undergo assessments including the Hamilton Depression Rating Scale HAMD-17 at baseline, Week 1, and Week 6, the Snaith-Hamilton Pleasure Scale SHAPS, and the Clinical Global Impression of Severity CGI-S score at Week 6. Safety and tolerability are monitored from screening through 8 weeks after the final dose. The primary outcome is the change from baseline in HAMD-17 at Week 6. Total participation may last several months, including screening, treatment, and follow-up periods.

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the safety, effectiveness, and how the body processes IDE892 when used alone or combined with other drugs like IDE397 in adults with advanced solid tumors that have a specific genetic change called MTAP deletion. This study focuses on participants whose cancer has progressed after standard treatment and aims to address a significant medical need by targeting vulnerabilities in tumors with this genetic deletion. Participants will receive IDE892 alone or combined with IDE397, an oral drug that blocks MAT2A, to improve treatment impact while maintaining safety. The study includes dose escalation phases to find the right dose and expansion phases to further assess the treatments effects. Different groups include those with various solid tumors and those with non-small cell lung cancer NSCLC, with treatment cycles lasting 21 days. During the study, participants will have blood and tumor tissue samples collected for biomarker testing and monitoring. Researchers will assess side effects, how well the drug is tolerated, tumor response, and drug levels in the body over approximately two years. Visits include regular safety checks and scans to evaluate tumors. Participants must comply with scheduled visits, treatment plans, and tests throughout the study.

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects and safety of praliciguat in adults diagnosed with biopsy-confirmed focal segmental glomerulosclerosis FSGS. This kidney condition is being studied to understand how praliciguat impacts protein levels in urine and other health measures compared to placebo. The study is sponsored by Akebia Therapeutics and involves multiple centers. Participants will be randomly assigned to receive either praliciguat or a matching placebo daily during a 24-week double-blind period. The praliciguat dose will be gradually increased to a target level. After this period, all participants will continue with an open-label phase where everyone receives praliciguat daily for another 24 weeks. Throughout the study, participants will have their urine protein-to-creatinine ratio UPCR measured from baseline through Week 24 to assess treatment effects. Additional evaluations include monitoring partial remission rates at Week 24 and measuring plasma praliciguat levels at Weeks 24, 32, and 36. The total participation lasts up to 48 weeks, with safety and efficacy assessments occurring regularly during and after the treatment periods.

Researchers are evaluating the use of SNP-ACTH 1-39 Gel compared to rituximab for treating adults with primary membranous nephropathy PMN, a kidney condition. This trial uses a two-phase adaptive design to find the best dose of SNP-ACTH Gel and then assess its effectiveness against rituximab. The study is divided into Phase 3a for dose finding and Phase 3b for comparing treatments over 24 months. In Phase 3a, up to 24 patients will be randomly assigned to receive either 3 mg or 5 mg of SNP-ACTH Gel by subcutaneous injection three times a week for 12 months. Data from this phase will guide dose selection for Phase 3b. In Phase 3b, 132 patients will be randomized to receive either the selected dose of SNP-ACTH Gel for 12 months or rituximab infusions given in two cycles, one at the start and one at six months. Participants will be monitored throughout the study with regular assessments of urinary protein and auto-antibody levels during Phase 3a, and clinical responses at 24 months in Phase 3b. Researchers will track kidney function, relapse rates, immune responses, and safety outcomes. Study visits and evaluations will occur at multiple time points up to two years, supporting detailed understanding of treatment effects and patient health over time.