Smithfield

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with Cutaneous Lupus Erythematosus, including Subacute and Chronic forms. The study focuses on participants who have active disease and have not responded adequately to conventional treatments. This Phase 2b trial aims to better understand how IMVT-1402 performs compared to a placebo in this patient group. The study includes three treatment periods. In Period 1, participants are randomly assigned to receive either IMVT-1402 Dose 1 or a placebo injection once weekly for 12 weeks. In Period 2, all participants who finished the first period receive IMVT-1402 Dose 1 once weekly for 14 weeks. In Period 3, after completing Period 2, participants are re-randomized to receive either IMVT-1402 Dose 1 or Dose 2 weekly for 26 weeks. All treatments are given as subcutaneous injections. Participants will be involved for about 61 weeks total. Researchers will measure changes in disease severity using the Cutaneous Lupus Erythematosus Disease area and Severity Index (CLASI-A) score from the start to Week 12. Throughout the study, safety and tolerability will be monitored, along with other assessments to track disease activity and participant health.

Researchers are evaluating the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-103 in adolescents and adults aged 12 to 35 years who have been recently diagnosed with Stage 3 Type 1 Diabetes within the past 6 months. This Phase 1b/2a first-in-human clinical trial aims to better understand how CNP-103 affects this population and to monitor any immune-related safety concerns. Participants will receive either CNP-103 or a placebo (0.9% sodium chloride injection) over a 90-day treatment period following a 28-day screening phase. The study includes multiple dose cohorts with weight-based eligibility criteria and requires participants to continue standard diabetes management including insulin therapy, nutrition plans, and exercise as appropriate. After treatment, participants will undergo post-dose evaluations lasting 275 days to monitor long-term safety and effects. Throughout the approximately 393-day study, participants will attend visits for assessments including safety and immune monitoring, pharmacodynamics evaluations, and efficacy measurements. Researchers will closely track adherence to medication and monitor laboratory tests, while safety and immune responses will be evaluated from Day 1 through Day 365. This comprehensive follow-up aims to gather detailed information on the participant's health and response to the investigational treatment over time.

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 a new digital therapy aimed at reducing the risk of posttraumatic stress disorder (PTSD) and cannabis use disorder (CUD) among women who have experienced sexual assault. This study focuses on women who seek emergency care within 72 hours after assault and aims to test the acceptability, early effectiveness, and working mechanisms of this novel intervention. The study will also support training in emergency-care based randomized clinical trials and advanced data analysis to help reduce the public health impact of PTSD and CUD in this vulnerable group. Participants will be divided into two groups. One group will use the RISE Guide, a brief cognitive behavioral therapy delivered via smartphone over three weeks, targeting anxiety sensitivity through education, cognitive retraining, and exercises to reduce fear of anxious feelings. This is followed by six weeks of personalized reminders and support using ecological momentary intervention. The other group will use the "Breathe2Relax" app, which teaches diaphragm breathing to manage stress, along with reminders to engage with the relaxation techniques and follow-up prompts via ecological momentary intervention. During the study, participants will be assessed for anxiety sensitivity after six weeks using the Anxiety Sensitivity Index-3. The study involves monitoring symptoms, delivering personalized interventions, and supporting adherence through digital reminders. Women will be screened and followed to evaluate the therapy's impact on PTSD and cannabis use disorder risk, with safety and participation tracked throughout the trial period.

Researchers are evaluating the safety and effectiveness of MANP (modified atrial natriuretic peptide) given by subcutaneous injection to reduce daytime systolic blood pressure in adults with difficult to control or resistant hypertension. This Phase 2 study compares MANP to a placebo in participants who are taking three or more antihypertensive medications with different mechanisms of action. The study focuses on people aged 18 to 80 years who have high blood pressure despite treatment. Participants will receive daily injections of either MANP or a placebo for 42 days. This dose-titration study monitors the response to the treatment over this period. The placebo used is a matched vehicle without the active ingredient. The study aims to observe changes in blood pressure and evaluate potential side effects during and after treatment. During the study, participants will have their blood pressure measured using 24-hour ambulatory blood pressure monitoring to assess changes from baseline. Researchers will also monitor and record any adverse events, serious adverse events, and treatment-emergent adverse events for up to four weeks after the treatment ends, which totals approximately 10 weeks of follow-up. These assessments help determine the safety and efficacy of MANP in this population.