East Orange

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 investigating a care approach called Concordant Care, which involves validating patients' experiences, developing a shared understanding of their condition, and creating patient-centered health plans. This study focuses on Veterans with Long-COVID, a poorly understood condition, aiming to improve how clinicians engage with these Veterans through specialized training. The research is divided into two parts: first, adapting and refining the Concordant Care training based on input from Veterans and providers; second, testing the training's impact on care practices and outcomes in a randomized trial. Clinicians in the study receive either Concordant Care training or an education packet about Long-COVID. The Concordant Care training includes about three hours of online learning, tele-mentoring sessions every two weeks, pocket cards as reminders, and electronic prompts sent to Veterans to encourage discussion about Long-COVID. The control group receives comprehensive information packets and guidance to VA trainings focused on whole health approaches. The study involves both Veterans and clinicians, with training adapted and tested for effectiveness in improving care conversations and shared understanding. Veterans who have scheduled appointments with participating clinicians are assessed before their visit and again about three months later. Researchers collect data on whether clinicians engage in recommended Concordant Care practices and how Veterans perceive their care experience. Primary outcomes include changes in care practices and how well Veterans and clinicians share understanding about Long-COVID. The study monitors satisfaction, adherence to care, and disability related to Long-COVID over this period, aiming to enhance care quality for Veterans with this condition.

Researchers are evaluating the effectiveness of Exposure and Response Prevention (ERP) therapy compared to a stress management training control in Veterans with Obsessive Compulsive Disorder (OCD), including those with both OCD and post-traumatic stress disorder (PTSD). This 4-year randomized clinical trial focuses on whether ERP can improve functioning, quality of life, and OCD symptoms among Veterans receiving care at various VA medical centers and telehealth hubs. Participants are randomly assigned to one of two groups: the ERP group receives 16 weekly therapy sessions delivered via video telehealth (VTH), emphasizing exposure to feared situations and prevention of compulsive rituals. The control group receives 16 weekly sessions of stress management training, which includes psychoeducation and skills such as deep breathing, relaxation, positive imagery, assertiveness, and problem solving. Both treatments include homework practice and symptom monitoring. Throughout the study, participants complete assessments at the end of treatment and six months later to measure changes in work and social functioning using the Work and Social Adjustment Scale (WSAS). Those in the ERP group also provide feedback on treatment satisfaction and participate in qualitative interviews about how the therapy affected their functioning and PTSD symptoms. Providers and VA administrators will also be interviewed to evaluate how ERP could be implemented in VA mental health care settings.

Researchers are studying Gulf War Illness (GWI), a condition affecting veterans exposed to chemical and environmental agents during the 1990-91 Gulf War. These exposures may damage cell and mitochondrial function, leading to oxidative stress and neuroinflammation in the central nervous system (CNS). This trial aims to evaluate whether N-Acetyl Cysteine (NAC), an antioxidant, can help the CNS recover from chronic oxidative stress and improve mitochondrial function in veterans with GWI. Participants will receive either NAC at a dose of 900 mg twice daily or a matching placebo. The study focuses on the ability of NAC to increase serum glutathione (GSH) levels and reduce oxidative stress in the CNS. This is a mechanistic early phase 1 study comparing NAC to placebo over an 8-week period. During the study, blood samples and neuroimaging will be used to measure glutathione levels before and after treatment. Participants will be monitored for changes in oxidative stress markers and CNS antioxidant status. The trial includes follow-up visits to assess safety and adherence, with the total study duration covering baseline through 8 weeks of treatment.

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 whether adding PET-directed local therapy to standard systemic therapy (SST) improves outcomes for Veterans with oligometastatic prostate cancer, which means having 1 to 10 metastatic sites. This phase II/III trial focuses on Veterans with recurrent or de novo oligometastatic prostate cancer to determine if PET-directed local therapy combined with SST can better control disease and extend castration-resistant prostate cancer-free survival compared to SST alone. The study also explores differences in cancer progression patterns, survival, quality of life, and genetic markers that may predict benefit from local therapy. Participants will receive standard systemic therapy, which may include androgen deprivation therapy alone or combined with anti-androgens, chemotherapy, or novel hormonal agents. Those randomized to receive PET-directed local therapy may undergo surgery, radiation (including stereotactic body radiotherapy or conventional fractionation), or salvage local treatments like brachytherapy, cryotherapy, or high-intensity focused ultrasound for local recurrence. Prostate-directed radiation is given for de novo cases, with treatment choices made collaboratively between the physician and Veteran. During the study, Veterans will undergo imaging scans such as PET/CT, bone scans, CT or MRI of the abdomen/pelvis, and have blood tests including PSA and testosterone levels. Researchers will monitor disease progression, survival, and quality of life over four years to measure castration-resistant prostate cancer-free survival. Genetic sequencing of tumor DNA will also be performed to assess potential predictive markers. The study is open-label and conducted across multiple centers, with Veterans actively involved in treatment decisions and follow-up assessments.