Somers Point

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 efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study 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 the effectiveness and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

Researchers are evaluating how effective, safe, and tolerable a vaccine for Clostridioides difficile (C. difficile) infection is in adults aged 65 years and older. The study focuses on reducing the number of C. difficile infections, which can cause diarrhea, in this older adult population. This is a Phase 3, placebo-controlled, double-blinded, randomized trial involving participants who are at risk because of recent or planned contact with healthcare systems or recent antibiotic use. Participants will receive either the C. difficile vaccine or a saline placebo. Both are given by injection into the upper arm muscle. The study includes 3 planned clinic visits and 3 phone visits initially, followed by yearly clinic visits until the study ends. Participants will remain in the study until enough infection events have occurred—this period may last up to about three and a half years, but could be shorter or longer depending on how quickly events happen or if the study stops early due to clear results. Throughout the study, participants will report any side effects such as local reactions and systemic events for 7 days after each vaccination, and adverse events for up to one month. Serious adverse events are monitored for up to 18 months after the last dose. If participants experience 3 or more loose stools within 24 hours during the study, they must save the next stool and contact the study team for infection testing. This ongoing monitoring helps assess the vaccine's impact on preventing medically attended C. difficile infections over time.

This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease. The study includes three sub-studies focusing on induction treatment, with specific co-primary endpoints assessing clinical remission and endoscopic response at 12 weeks. Participants will receive either duvakitug or a placebo via subcutaneous injection during the treatment periods. The study duration can last up to 35 weeks and consists of a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 (open-label feeder induction) or Sub-Study 2 (pivotal induction). Non-responders may enter a 12-week extended induction phase in Sub-Study 3. After treatment, participants not enrolling in the maintenance study will have a 6-week follow-up period. Throughout the study, participants will have scheduled visits for assessments, including monitoring of clinical remission and endoscopic response using standardized scoring systems at 12 weeks. The total number of visits varies depending on sub-study participation, with up to 15 visits for those in Sub-Study 3. Safety and treatment effects will be closely monitored during these visits and follow-up periods.

Researchers are evaluating the safety and effectiveness of duvakitug in people with moderately to severely active Ulcerative Colitis (UC). This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to see if duvakitug can help achieve clinical remission in this condition. The study targets participants aged 16 to 80 years with a confirmed diagnosis of active UC for at least 3 months who have not responded well or are intolerant to other treatments. Participants will receive either duvakitug or a placebo as a solution injected under the skin (subcutaneous injection). The study includes up to 35 weeks with multiple periods: a screening period, a 12-week induction phase (either open-label or randomized), a 12-week extended induction for those who do not respond initially, and a 45-day follow-up for those not continuing into the maintenance study. During these phases, participants may have up to 8 to 15 on-site visits depending on their sub-study group. Throughout the study, participants will be monitored closely with scheduled visits for assessments including clinical evaluations related to UC activity and response to treatment. The main outcome measured is the proportion of participants who achieve clinical remission by week 12. Safety and tolerability will also be tracked during and after the treatment period, with follow-up visits to ensure participant well-being.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of the HIT Reverse Hip Replacement System in patients undergoing primary total hip arthroplasty (THA). This randomized, controlled, multi-center clinical trial compares the investigational device to already-marketed semi-constrained uncemented hip systems using metal-on-highly cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearings. The study includes patients aged 50 to 75 who require hip replacement due to degenerative joint disease, osteoarthritis, avascular necrosis, or traumatic arthropathy of the hip. Participants are randomly assigned to receive either the HIT Reverse Hip Replacement System or one of several control hip systems, including devices from DePuy Synthes, Zimmer Biomet, Stryker, or Smith & Nephew. Implantation is performed using standard surgical procedures for THA described in the respective instructions for use. Post-surgical care and rehabilitation follow standard care practices for both treatment groups. During the study, participants will attend follow-up visits over 24 months to assess outcomes including hip function using the Oxford Hip Score (OHS), radiologic success, and absence of revision surgery. Researchers will measure changes in OHS from baseline, aiming for an OHS of 36 or more and a change of 12 or more at the 2-year follow-up. Safety and device performance will be monitored throughout the study period to evaluate effectiveness and potential risks.

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, to prevent recurrent Clostridioides difficile infection (CDI). This randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the safety and CDI recurrence rate at 8 weeks in participants receiving a 14-day course of VE303 or a matching placebo. The study includes two stages: one focusing on participants with recurrent CDI and the other on those with primary CDI at high risk of recurrence. Participants will receive either VE303 or placebo capsules that look identical and contain no active drug. The treatment lasts for 14 days, starting on the last planned day of standard antibiotic therapy for the qualifying CDI episode or within 2 days after completing antibiotics. Participants must have completed and responded to standard antibiotic treatment before receiving study medication. The study evaluates the effect of VE303 versus placebo on preventing CDI recurrence after antibiotic therapy. During the study, participants will be monitored through clinical evaluations to track CDI recurrence by Week 8, including stool samples tested for CDI. Safety and clinical response will be assessed throughout the study period. Participants are followed to ensure stability after the qualifying CDI episode and to monitor any complications or adverse events. The total participation duration includes treatment and follow-up through Week 8 to measure CDI recurrence rates and safety.