Caledonia

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab in adults with moderate to severe chronic spontaneous urticaria (CSU) that is not adequately controlled by second generation H1-antihistamines (sgH1-AHs). This Phase 3b, multi-center, randomized, double-blind, double-dummy study is conducted in the US and focuses on early treatment effects at 4 weeks and earlier. The study includes a screening period of up to 4 weeks, followed by a 12-week core treatment period where about 400 participants are randomly assigned to receive either remibrutinib (25 mg twice daily by mouth) with a placebo injection or dupilumab (a 600 mg loading dose followed by 300 mg every 2 weeks by injection) with a placebo tablet. All participants continue their stable dose of sgH1-AH during this period, with the option to add rescue doses if needed, not exceeding four times the standard dose per day. After the core period, participants may join an optional open-label extension to receive remibrutinib for an additional 12 weeks if the drug is not commercially available. Participants will complete daily diaries and regular assessments to track urticaria symptoms and treatment effects. Researchers will measure changes in the Weekly Urticaria Activity Score (UAS7) from the start to Week 4. Safety follow-up will occur for 12 weeks after treatment ends, with phone calls and site visits as needed, continuing longer if participants join the extension. The total study duration includes screening, treatment, optional extension, and safety follow-up phases.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab therapy in people with moderate-to-severe plaque psoriasis who are also overweight or obese with at least one related health condition. This study is a phase 4, open-label, single-arm trial focused on real-world clinical practice. The goal is to see how well this combination works over a 12-month period. Participants will continue treatment with ixekizumab and start tirzepatide, which is given by injection under the skin. To join, participants must have started ixekizumab about three months before adding tirzepatide. The study monitors treatment beginning at baseline and follows participants for up to one year to assess outcomes. During the study, researchers will measure how many participants improve their skin-related quality of life using the Dermatology Life Quality Index and how many achieve at least a 10% weight reduction after 12 months. Participants will be regularly evaluated to track these outcomes and monitor safety throughout the study period.

Researchers are evaluating the real-world effectiveness of nemolizumab in treating moderate-to-severe Prurigo Nodularis (PN) in adults. This non-interventional, prospective, multicenter study focuses on physician assessments and patient-reported outcomes over approximately 12 months in routine clinical settings. The study aims to measure improvements using both investigator and patient evaluations at Month 6. Treatment with nemolizumab (Nemluvio) is decided by the participant's physician before enrollment, with no additional visits or tests beyond usual care. Visit schedules follow standard medical practice rather than study requirements. A sub-study in Germany and the UK involves daily remote completion of Peak Pruritus Numerical Rating Scale (PP NRS) and Sleep Disturbance NRS from Day -1 to Day 14 without clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcomes are collected. The main outcomes measured include the Investigator Global Assessment of chronic Prurigo (IGA-CPG stage) and Peak Pruritus Numerical Rating Scale at 6 months. Data collection relies on standard practice, with no extra procedures, and monitoring occurs throughout the study duration of about one year.

Researchers are evaluating the real-world effectiveness of nemolizumab for treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults. This study is a prospective, multicenter, non-interventional trial that aims to measure treatment outcomes through physician assessments and patient-reported outcomes over approximately 12 months. The goal is to understand how nemolizumab works in routine clinical practice, focusing on physician evaluations and patient experiences at Month 6. Treatment with nemolizumab is determined solely by the participant's physician before joining the study, with no extra visits, procedures, or lab tests beyond standard care. The study does not define a specific visit schedule; instead, visits follow routine medical practice to collect data systematically. A sub-study in Germany and the UK will have participants complete daily questionnaires on itch severity, sleep disturbance, and pain from Day -1 to Day 14 remotely, without requiring clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcome measures will be gathered. Key outcomes measured include the Investigator Global Assessment (IGA) and the Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6. The study observes participant responses and safety under normal care conditions, with data collection lasting about a year to evaluate nemolizumab's effectiveness in everyday treatment settings.

Researchers are conducting a prospective non-interventional study to better understand the needs and treatment experiences of adolescents and adults with atopic dermatitis (AD). The study aims to assess safety and clinical outcomes of systemic AD treatments in real-world settings while exploring patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbidities, and lesion characteristics. This study will take place across 10 countries in 4 geographic regions and will follow participants for 5 years. Participants who have a confirmed diagnosis of AD and are at least 12 years old will be included if they are prescribed and scheduled to start any systemic treatment for AD, including biologics, oral Janus kinase inhibitors, cyclosporine, and other immunosuppressants. The study involves monitoring patients who initiate or switch systemic treatments to evaluate treatment patterns over time. During the study, researchers will track a range of outcomes from baseline through up to 60 months, including the number of participants using AD treatments, treatment duration, treatment changes, and reasons for starting, interrupting, switching, or stopping treatments. Disease severity and control will be measured by tools like the Eczema Area and Severity Index and atopic dermatitis control tests. Patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall severity impressions will also be assessed. The long follow-up allows for observing remission and the evolving treatment journey in diverse patients.