Glen Burnie

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

Researchers are evaluating the long-term safety and effectiveness of TAK-279 (also called Zasocitinib) in adults with moderately to severely active Crohn's Disease or Ulcerative Colitis, which are serious inflammatory bowel diseases causing pain and swelling in the intestines. This study is an extension of two earlier phase 2 trials where participants who responded to TAK-279 may continue to receive treatment. The goal is to understand how well TAK-279 controls bowel inflammation and symptoms when used for up to two years. Participants will receive oral Zasocitinib capsules for up to 108 weeks. During this time, they will attend 11 visits at their study clinic for treatment and monitoring. This open-label extension study focuses on long-term safety, tolerability, and sustained response in those who showed improvement in the initial parent trials. Throughout the study, researchers will track the number of participants experiencing treatment-related side effects, significant changes in vital signs, lab tests, and ECG results. Participants' symptoms and inflammation will be regularly assessed to monitor TAK-279's ongoing effects. The study includes safety monitoring from the start of treatment to week 112, with careful attention to any adverse events or important changes in health measurements.

Researchers are evaluating two investigational drugs, 68Ga-R11228 and 177Lu-R11228, in patients with metastatic or locoregionally recurrent estrogen and/or progesterone receptor-positive (ER+/PR+) and HER2-negative breast cancer. This phase 1 study aims to assess the safety and effectiveness of these drugs in detecting and treating tumor lesions. The study includes patients who have hormone receptor-positive breast cancer that has recurred or spread and focuses on understanding adverse events and dose-limiting toxicities associated with the treatments. The study has two parts. Part A tests 68Ga-R11228, a gallium-labeled radioligand designed to locate tumor lesions and make them visible on PET scans. Participants receive a single dose at one of three dose levels. Part B tests both 68Ga-R11228 for imaging and 177Lu-R11228, a lutetium-labeled radioligand designed to treat tumor lesions identified by PET scans. Eligible patients in Part B receive up to six doses of 177Lu-R11228 over approximately 36 weeks, with multiple dose levels evaluated. After treatment, participants enter a 5-year follow-up period to monitor long-term effects. Participants will undergo PET scans to identify tumor lesions and receive the investigational drugs as scheduled. Researchers will monitor safety by tracking adverse events and serious adverse events from Day 1 through Week 36, as well as dose-limiting toxicities. Assessments include clinical examinations, brain imaging for those with prior brain metastases, and laboratory tests to evaluate bone marrow, liver, and kidney function. The total involvement includes treatment periods and long-term follow-up to ensure participant safety and gather comprehensive data on the drugs' effects.

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating whether adding radiation before chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who may be eligible for surgery. This Phase 1 study focuses on patients with borderline resectable NSCLC and aims to assess the tolerability of combining stereotactic body radiation therapy (SBRT) with standard chemoimmunotherapy. The standard chemoimmunotherapy includes chemotherapy drugs such as carboplatin or cisplatin with pemetrexed, paclitaxel, or gemcitabine, along with the immunotherapy drug nivolumab. Participants will receive three doses of SBRT radiation every other day over three days, with the final radiation dose given within seven days of starting chemoimmunotherapy. The chemoimmunotherapy regimen involves intravenous nivolumab every three weeks for up to three cycles (totaling nine weeks), combined with chemotherapy drugs as described. After completing these treatments, patients will be evaluated for surgical removal of the tumor. During the study, participants will be followed for up to 100 days after their last chemoimmunotherapy dose to monitor side effects. Researchers will review medical records during and after this period to track cancer outcomes such as survival and recurrence. The study measures tolerability of adding radiation to the standard treatment within 20 weeks of starting therapy, aiming to better understand the combined treatment's safety and effects.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.