Carolina

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are evaluating the effectiveness and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation, and some people require systemic treatments beyond topical therapies. This phase 3b/4 study aims to provide data on upadacitinib's impact on AD symptoms in this specific population. The study is conducted in two open-label periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg orally once daily or dupilumab 300mg by subcutaneous injection every two weeks. After two weeks, those on upadacitinib 15mg may have their dose increased to 30mg based on their response. Period 2 lasts 24 weeks, during which participants either continue their assigned dose or switch doses depending on their eczema severity scores. The entire treatment duration is 32 weeks with follow-up for 30 days after treatment ends. Participants will undergo regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The main outcome measured is the number of participants achieving at least a 90% improvement in their eczema severity index by week 8. The study includes a 35-day screening period before treatment begins and monitors safety and efficacy throughout the study duration.

This trial investigates treatments for children aged 2 to less than 12 years with moderate to severe atopic dermatitis, a skin condition causing rash and itching due to inflammation. It compares oral upadacitinib, a drug approved for patients 12 years and older, with subcutaneous dupilumab, focusing on safety, adverse events, and changes in disease activity. The study is phase 3, open-label, and efficacy-assessor-blinded, enrolling about 675 participants worldwide who require systemic anti-inflammatory treatment beyond topical therapies. Participants will be randomly assigned to receive upadacitinib daily as oral tablets or oral solution for 160 weeks, or dupilumab by injection according to its approved dosing every 2 or 4 weeks for 52 weeks. Participants are stratified by disease severity, age, and previous treatment response. After completing treatment, follow-up visits occur for 30 days after upadacitinib and at least 12 weeks after dupilumab. The trial may involve more treatment visits than standard care. Throughout the study, participants attend regular hospital or clinic visits for clinical assessments, blood tests, and questionnaires to monitor disease severity and side effects. Researchers measure the percentage of participants achieving significant improvement in eczema severity by week 16 and track adverse events up to about week 172. This careful monitoring helps evaluate the safety and efficacy of the treatments over the long term.

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.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

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 safety and effectiveness of brivekimig in adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition. This Phase 2b, global, multi-center study is designed as a randomized, double-blind, placebo-controlled trial that tests different doses of brivekimig. The study aims to understand how well brivekimig works compared to a placebo in improving HS symptoms and to find the best dose. Participants will receive either brivekimig or a placebo as a subcutaneous injection. The study includes a dose-ranging phase followed by a maintenance period. The total duration of treatment in the randomized phase can last up to approximately 48 weeks. For those not entering the long-term extension, the study duration will be about 60 weeks, and for those transitioning to the long-term extension, it will be about 52 weeks. During the study, participants will be monitored regularly to assess their response to treatment, including the percentage achieving a clinical response called HiSCR75 by Week 16. Researchers will evaluate safety and efficacy through clinical assessments and follow participants throughout the study period. The total involvement per participant lasts up to around 60 weeks depending on extension study participation.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

The trial investigates the long-term safety and tolerability of KarXT in people with psychosis associated with Alzheimer's Disease. This Phase 3 global, multicenter, open-label extension study lasts 52 weeks and enrolls participants who have completed earlier related studies (CN012-0026, CN012-0027, or CN012-0056). The purpose is to monitor how well patients tolerate KarXT over an extended period and to collect safety data. Participants receive KarXT in varying doses taken three times daily, ranging from 20/2 mg up to 66.7/6.67 mg per dose, corresponding to total daily doses between 60/6 mg and 200/20 mg. This treatment is provided throughout the 52-week open-label extension. The study includes only those who completed the previous related studies and continues to assess their response to KarXT over this longer timeframe. During the study, participants are closely monitored for treatment-emergent adverse events from the first dose through 14 days after the final dose, which may be up to 54 weeks. Regular assessments ensure safety and tolerability, and caregivers are involved to support participants. The study also evaluates participants' ability to continue living in their current setting and requires consent from the participant or their legal representative. Overall, the study tracks long-term safety outcomes in this specific patient group.