Salisbury

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC). This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

This trial focuses on adults with uncontrolled gout, investigating the effects of pegloticase given with methotrexate (MTX). Researchers aim to compare two ways of delivering pegloticase: subcutaneous (under the skin) and intravenous (into a vein). The main goal is to see how well each method maintains normal levels of serum uric acid during the sixth month of treatment. Participants will be randomly assigned to receive either pegloticase 18 mg by subcutaneous injection every two weeks with MTX or pegloticase 8 mg by intravenous infusion every two weeks with MTX. MTX is taken orally weekly. Both groups are monitored under a double-blind design, meaning neither participants nor researchers know which treatment is given to ensure unbiased results. During the study, participants will have their serum uric acid levels checked regularly, especially at weeks 20 through 24 to assess response. Researchers will also monitor for serious injection site reactions and infusion reactions, including anaphylaxis, up to week 48. The study includes assessments of drug levels in the blood and safety monitoring throughout. Participation lasts at least six months with ongoing evaluations to track efficacy and safety.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjögren's Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate (BGF MDI 320/14.4/9.6 bcg) on heart and lung outcomes in people with chronic obstructive pulmonary disease (COPD) who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate (GFF MDI 14.4/9.6 bcg). The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. This Phase 3 randomized, double-blind trial aims to assess the efficacy, safety, and tolerability of these treatments in this specific patient population. Participants will receive either adagrasib with pembrolizumab and chemotherapy drugs carboplatin or cisplatin plus pemetrexed, or a placebo combined with pembrolizumab and the same chemotherapy drugs. Dosing schedules are specified but not detailed here, and treatment is given according to the study's protocol. The trial includes a placebo comparator group and uses quadruple masking to maintain blinding. Throughout the study, participants will be monitored for progression-free survival and overall survival for up to seven years. Assessments include imaging scans to measure tumor response, quality of life questionnaires, and monitoring for adverse events related to treatment. Safety evaluations continue for up to 90 days after the last dose. The study duration varies, with extensive follow-up to track treatment outcomes and side effects.

Researchers are evaluating the effects of RSLV-132 in adult females with Primary Sjögren Syndrome (pSS), a condition characterized by symptoms like fatigue, dryness, and pain. This Phase 2 clinical trial aims to determine if RSLV-132 improves these key symptoms, assess its safety, and study immune responses and blood levels of the drug over time. The study compares RSLV-132 to a placebo to understand its impact on symptom relief and safety in participants with moderate to severe symptom burden. Participants receive intravenous infusions of either 10 mg/kg RSLV-132 or a placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155, covering a total of 22 weeks of treatment. This double-blind, randomized study includes regular clinic visits weekly for the first two weeks, then every two weeks until the end of treatment, with a final follow-up visit at Day 211. Each infusion and visit involves monitoring and assessments to track progress and responses. During the study, participants will record their symptoms daily using an electronic device and attend scheduled clinic visits for check-ups, tests, and questionnaires. Researchers will assess fatigue and tiredness, measure drug levels and immune responses in blood samples, and monitor for any adverse events throughout and after treatment. The main outcome focuses on the evaluation of key symptoms of Sjögren's disease, with safety and immune response also closely observed until Day 211.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 2/3, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone (TSH) levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are evaluating CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab treatment in adults with active psoriatic arthritis who are overweight or have obesity along with at least one weight-related health condition. This study is a Phase 4, open-label, single-arm trial conducted in real-world clinical practice and will last up to 12 months. The main goal is to see how well this combination improves physical function and helps with weight loss. Participants will continue their current ixekizumab therapy and begin taking tirzepatide by subcutaneous injection according to the approved label. The study involves a single treatment group receiving this combination, and treatment starts within 30 days of deciding to add tirzepatide. The study duration is one year, during which participants are monitored for health outcomes and treatment effects. During the study, participants will have regular assessments including joint counts, skin condition measurements, pain and disease activity ratings, fatigue evaluations, and quality of life surveys. Researchers will measure improvements in functioning and weight loss at 6 and 12 months. Safety and health will be monitored throughout. The total participation time is up to 12 months from starting tirzepatide.

Researchers are evaluating the effectiveness, safety, and tolerability of a vaccine designed to reduce Clostridioides difficile (C. difficile) infections in adults aged 65 years and older. This phase 3 study compares the vaccine to a placebo in a group of older adults who have recent or planned contact with healthcare systems or recent antibiotic use. The purpose is to understand how well the vaccine works to prevent infections and to monitor any side effects or reactions. Participants will receive either the C. difficile vaccine or a placebo shot injected into the upper arm muscle. The study is randomized, double-blinded, and placebo-controlled. The vaccination period includes two doses and participants will be monitored for up to about three and a half years. Follow-up includes three planned clinical visits and three phone visits initially, then yearly clinic visits until the study ends. Participants are asked to report and save stool samples if they experience three or more loose stools in 24 hours to check for possible infection. During the study, researchers will track local and systemic reactions to the vaccine within seven days after each shot, adverse events up to one month after each vaccination, and serious adverse events for up to 18 months after the last dose. The main measurement is the occurrence of medically attended primary C. difficile infections from two weeks after the second vaccination through the surveillance period. Safety monitoring and annual visits will continue until the study is completed, which could be sooner or later depending on infection rates.