Wheaton

Researchers are evaluating the dose-response relationship of galvokimig compared with placebo in adults with moderate-to-severe atopic dermatitis AtD. The study focuses on participants who have had chronic AtD for at least one year and aims to assess how different doses of galvokimig impact the condition. This phase 2 trial is designed to better understand the drugs effects on symptoms and safety in this population. Participants are randomly assigned to one of several groups receiving different predefined doses of galvokimig or a matching placebo during an initial 16-week intervention period. After week 16, participants continue treatment with the same or a modified dose of galvokimig. The study uses a double-blind design to compare the effects of these doses on atopic dermatitis. During the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment vIGA, and Peak Pruritus Numerical Rating Scale PP-NRS. Safety is monitored through reported adverse events up to week 58. The primary outcome is the percentage of participants achieving a significant improvement in EASI score at week 16. The total study duration extends beyond 16 weeks to include ongoing safety and response evaluations.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab as add-on treatments for adults with moderate to severe chronic spontaneous urticaria CSU that is not well controlled by second generation H1-antihistamines sgH1-AH. This Phase 3b, multi-center, randomized, double-blind, double-dummy study focuses on early treatment effects within 4 weeks. The study addresses the need for better management of CSU symptoms such as hives and itch. Participants will be assigned to one of two treatment groups one group will receive remibrutinib tablets twice daily plus placebo injections, while the other group will receive dupilumab injections with matching placebo tablets. Both groups continue their stable background therapy of sgH1-AH daily. The study includes a screening period up to 4 weeks, a 12-week core double-blind treatment period, and an optional 12-week open-label extension where all participants may receive remibrutinib if it is not commercially available. After treatment, safety follow-up occurs for up to 12 weeks, with phone calls and possible site visits. Participants will be monitored through regular assessments including symptom severity scores, urticaria activity scores, and daily diaries. Safety follow-up includes phone calls and visits depending on treatment continuation. The main outcome is the change in weekly urticaria activity score at Week 4. Other measures include severity of hives and itch at Weeks 1 and 4. Total study participation may last up to 24 weeks, including optional extension and follow-up phases.

This research aims to collect urine and tumor samples along with clinical data from patients being evaluated, treated, or monitored for urothelial carcinoma, including bladder cancer. It is a prospective, multicenter observational study designed to validate a new testing platform called UroAmp for detecting and surveilling bladder cancer and related conditions. Participants provide a urine sample at enrollment using a proprietary urine collection system. They are then followed for up to five years, during which urine samples, tissue samples when applicable, and clinical information are collected during their routine care visits. The study includes two groups patients with bladder or upper tract urothelial carcinoma and hematuria controls without cancer history. Participants will be involved in regular clinical visits as part of their standard care, during which samples and data are collected. Researchers will measure outcomes such as recurrence-free survival and diagnostic accuracy for hematuria evaluation over up to five years. The study also compares UroAmp to other urine biomarkers and assesses early detection of cancer recurrence, ensuring ongoing monitoring and data collection throughout the follow-up period.

This trial studies parents or caregivers grieving the traumatic or unexpected death of a child under 25 years old. It compares two approaches to support these bereaved parents after their loss, addressing a gap in medical examiner or coroner ME services who often have limited training in helping grieving families. The goal is to find effective ways to connect parents to grief resources and improve their mental and physical health during this difficult time. Participants are randomly assigned to one of two interventions managed by Missing Pieces, a community-based organization helping families find grief support. The first intervention, CommunityRx-Bereavement CRx-B, offers personalized support with a Grief Navigator who contacts parents by phone or text, provides tailored grief resources, and maintains contact over 12 months. The second intervention, General Bereavement Support Information GBSI, sends parents general grief resource links via unidirectional text messages at multiple times after the childs death. Parents complete surveys about 6.5 months after their childs death to evaluate outcomes like their confidence in finding resources and experiences of complicated grief. The study monitors how well these interventions support parents over time, with the trial running from 2024 to early 2028. Participants are involved through referrals from medical examiners or coroners and ongoing communication from Missing Pieces, aiming to improve bereavement care systems.