Salem

Researchers are evaluating the safety, tolerability, and effectiveness of DermaBind TL, a placental membrane allograft, in adult patients with chronic non-healing wounds such as diabetic foot ulcers and venous leg ulcers. This Phase 4, open-label, single-arm clinical trial aims to collect patient outcome data over a 12-week treatment period, comparing results to each participant's historical treatment data. The study focuses on wound area preservation, infection rates, wound recurrence, graft usage, and treatment-emergent adverse events. During the 12-week treatment phase, participants will receive DermaBind TL applied to their affected chronic wounds. The trial involves two phases: screening and treatment. Clinicians will assess wounds regularly, and the intervention will be monitored for its ability to protect wounds, reduce infections, and promote healing. The study includes careful evaluation of wound characteristics and patient response to the graft treatment. Participants will be closely monitored throughout the trial, including wound assessments by clinicians and data collection on infection rates, wound size, and safety events. The primary outcome is to measure how well the wound covering protects the wound over the 13-week treatment period. The study also tracks adverse events and other clinical outcomes through the end of the study. Overall participation includes screening and a 12-week treatment period, with detailed follow-up to evaluate the intervention's effects.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating two forms of buprenorphine treatment for Veterans with moderate to severe opioid use disorder (OUD). This Phase 4, open-label, randomized controlled trial aims to compare a 28-day injectable subcutaneous buprenorphine formulation at a target dose of 300 mg with the standard daily sublingual buprenorphine dose ranging from 4 to 32 mg. The study will recruit 952 Veterans over seven years and follow them actively for 52 weeks, with additional passive follow-up via medical records for up to 10 years. The study also explores secondary outcomes including other substance use, overdose incidents, infections like HIV and hepatitis, incarceration, quality of life, mental health symptoms, housing, dental health, and cost-effectiveness. Participants will begin induction on daily sublingual buprenorphine using standard guidelines to reach a target dose between 4 and 32 mg within 45 days. After reaching this dose, participants are randomly assigned to either continue daily sublingual buprenorphine with naloxone, prescribed in 28-day take-home supplies, or receive monthly injectable buprenorphine administered in the clinic. Both treatment groups have visits at weeks 1, 2, 3, and 4 post-randomization, then every two weeks until week 52, with medication management provided at each visit. During the study, participants will provide self-reports of opioid abstinence and undergo urine drug screenings every two weeks. Medication adherence and retention in treatment are tracked approximately every four weeks. After the active 52-week period, participants will be followed passively through electronic medical records for up to 10 years to monitor long-term outcomes. This comprehensive approach aims to assess the effectiveness and safety of these treatments for opioid use disorder in Veterans.

Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.

Researchers are evaluating the combination of fruquintinib and FOLFIRI as a second-line treatment for participants with metastatic colorectal cancer (mCRC). This open-label, multicenter Phase II study focuses on participants who have previously received FOLFOX and Bevacizumab-based first-line therapy. The study aims to assess the effectiveness and safety of this combination in treating mCRC, especially in those with histologically confirmed adenocarcinoma of the colon or rectum. Participants will receive oral fruquintinib daily for the first 21 days of each 28-day cycle. In addition, FOLFIRI will be administered intravenously every two weeks on day 1 of each 28-day cycle, consisting of irinotecan, leucovorin, and 5-fluorouracil delivered by bolus and continuous infusion. Up to 60 participants will receive this combination treatment and be monitored throughout the study. During the study, participants will be assessed every two cycles (each cycle lasting 28 days) for up to two years or until disease progression or death. Researchers will measure progression-free survival at six months as the primary outcome. Safety and efficacy will be closely monitored through regular evaluations, including physical exams, laboratory tests, and imaging to track tumor response and treatment effects.

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating the effectiveness and safety of standard chemotherapy alone or combined with INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma (PDAC) with a KRAS G12D mutation. This phase 3, randomized, double-blind study focuses on individuals who have not received prior treatment for metastatic PDAC. The goal is to understand if adding INCB161734 to chemotherapy improves outcomes in this group of patients. Participants will receive either oral INCB161734 tablets or a placebo, along with a chemotherapy regimen selected by the investigator following specific protocol requirements. The chemotherapy options are defined by the study protocol. Treatments will be administered as planned during the study period, with careful monitoring to assess their effects. Throughout the study, participants will be monitored for overall survival up to approximately three years, progression-free survival, and objective tumor response assessed up to about two years. Researchers will conduct regular evaluations including clinical assessments and imaging reviewed by blinded independent central review (BICR). Safety and efficacy data will be collected to understand the impact of the treatments over time.

Researchers are evaluating the effectiveness and safety of ENERGI-F703 GEL compared to a placebo gel in adults with diabetic foot ulcers classified as Wagner Grade 1 or Grade 2. This Phase 3, randomized, double-blind, vehicle-controlled study includes participants with ulcers of different sizes and aims to understand how well the gel helps in healing these ulcers. The study involves multiple centers and uses stratification based on ulcer size to balance treatment groups. Participants are randomly assigned to receive either ENERGI-F703 GEL or a matching placebo gel along with standard care for their diabetic foot ulcers. The treatment phase lasts 16 weeks during which the gels are applied. The entire study duration can last up to 31 weeks, including a screening period of approximately 2 to 3 weeks before treatment and a 12-week safety follow-up after the last treatment dose. During the study, participants will undergo assessments to monitor ulcer healing, focusing on the complete closure rate of the ulcer by week 16. Researchers will also track safety through follow-up visits for 12 weeks after treatment ends. Participants will be evaluated regularly for ulcer size, condition, and overall health to measure treatment outcomes and ensure safety throughout the study.