Caledonia

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

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.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

Researchers are evaluating the effectiveness of adding the drug tirzepatide to the existing treatment with ixekizumab in adults with moderate-to-severe plaque psoriasis who are also overweight or obese and have at least one related health condition. This Phase 4 study aims to understand how well this combination works in routine clinical practice over a period of up to 12 months. During the study, participants will continue their treatment with ixekizumab and will start taking tirzepatide by subcutaneous injection according to the medication label. The study is open-label and involves a single group of participants receiving this combined treatment regimen. The main focus is to assess improvements in quality of life and weight reduction over the 12-month period. Participants will be monitored regularly to measure their skin condition using tools like the Dermatology Life Quality Index and body surface area affected by psoriasis. Weight changes and other health assessments will be tracked at 6 and 12 months. Safety and treatment adherence will also be observed throughout the study duration to gather comprehensive data on the effects of adding tirzepatide to ixekizumab therapy.

Researchers are studying the real-world effectiveness of nemolizumab in adults with moderate-to-severe Prurigo nodularis PN, a chronic skin condition. This observational study aims to assess outcomes reported by both investigators and patients over six months, focusing on how the treatment works in routine clinical practice. The study follows adults newly prescribed nemolizumab by their physicians. Participants will be observed for about 12 months while receiving treatment as part of their regular medical care. No extra visits, procedures, or lab tests beyond usual clinical practice are required. A sub-study in Germany and the UK will have some participants record their itch intensity and sleep disturbance daily for the first two weeks through remote data collection. Participants will have routine clinical visits determined by their doctors, with data collected during these visits. Researchers will assess outcomes such as the Investigator Global Assessment of chronic prurigo and patient-reported peak itch intensity at six months and up to 12 months. Sleep disturbance and prurigo activity will also be tracked. This approach allows long-term monitoring of treatment effects in a real-world setting without added study-related procedures.

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.

Researchers are evaluating the efficacy and safety of ICP-332 in adults aged 18 to 75 years with Prurigo Nodularis PN, a chronic skin condition characterized by itchy nodules. This phase 2, randomized, double-blind, placebo-controlled study aims to investigate different doses of ICP-332 for treating PN, addressing the need for effective therapies in patients with this condition. The trial is sponsored by Beijing InnoCare Pharma Tech Co., Ltd. and uses a parallel study design with multiple groups. Participants are randomly assigned to receive either ICP-332 at doses of 80 mg or 120 mg or a placebo. The study compares these groups over a period of up to 40 weeks, with primary assessment focusing on peak itch intensity using a numeric rating scale from baseline to week 16. Secondary measures include longer-term itch improvement, skin condition scores, quality of life assessments, drug concentration levels, and safety monitoring of adverse events from baseline through week 40. During the trial, participants will undergo regular evaluations including itch severity scales, skin assessments, quality of life questionnaires, and laboratory tests to monitor drug levels and safety. The study tracks outcomes up to 40 weeks to assess both efficacy and tolerability. Participants are expected to adhere to study visits and procedures as scheduled, with safety and treatment response closely monitored throughout the trial duration.

Researchers are conducting a prospective non-interventional study to better understand the needs and experiences of adolescent and adult patients with atopic dermatitis AD who start or switch any systemic treatment. The study aims to assess patient journeys and evaluate the safety and clinical outcomes of systemic AD treatments in real-world settings across multiple countries and geographical regions. Patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbid conditions, and lesion characteristics will be studied to gain a broad understanding of treatment impact. Participants in this observational study will be those who initiate or switch systemic treatments for AD, including biologics, oral Janus kinase JAK inhibitors, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil, based on country-specific prescribing information and standard of care. Treatments will be prescribed by investigators according to usual medical judgment, without any experimental intervention from the study. This study will follow participants for up to five years to observe treatment patterns and outcomes. During the study, participants will have their treatment utilization, treatment duration, switching, dose modifications, and reasons for changes recorded. Researchers will also measure changes in the severity and extent of AD using tools like the Eczema Area and Severity Index EASI, Body Surface Area BSA, Investigators Global Assessment, and patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall disease control. Other assessments include quality of life, work productivity, comorbid conditions, and adverse events. The study will provide long-term observational data over a period of up to 60 months.