Manises

This research aims to evaluate the effectiveness, safety, and tolerability of two doses of remibrutinib compared to placebo in people aged 12 years and older with moderate to severe hidradenitis suppurativa, a chronic skin condition. The study is a phase 3 clinical trial involving participants with a diagnosis lasting at least six months and active symptoms in multiple body areas. The purpose is to determine how well remibrutinib works and how safe and tolerable it is for this condition. The trial lasts a total of 76 weeks and includes several parts: a screening period of up to 4 weeks, a first treatment period of 16 weeks where participants receive either remibrutinib Dose A, Dose B, or placebo in a double-blind manner, followed by a second treatment period lasting 52 weeks during which all participants receive remibrutinib doses. After treatment, there is a 4-week safety follow-up without treatment. Participants stopping treatment early are encouraged to continue in the study and complete the safety follow-up. During the study, participants will be regularly monitored for their response to treatment, including the proportion who achieve a clinical response measure called HiSCR50 at Week 16. Assessments will include physical exams and safety checks throughout the treatment periods and follow-up. The study seeks to gather detailed information on how remibrutinib affects the severity of hidradenitis suppurativa and participants' overall health during and after treatment.

Researchers are evaluating multiple dosing schedules of LAD191 compared to placebo in adults with moderate-to-severe Hidradenitis Suppurativa (HS). This Phase 2a/2b study aims to assess the effectiveness, safety, tolerability, pharmacokinetics, and immune response to LAD191 in this population. The study uses an adaptive design with interim analysis to evaluate the treatments' futility. Participants will undergo up to a 4-week screening, followed by a 16-week double-blind, placebo-controlled treatment period, then a 16-week LAD191 double-blind treatment period, and finally a 12-week safety follow-up. Participants will be randomly assigned to receive one of three doses of LAD191, Adalimumab, or placebo, all given by subcutaneous injection. Throughout the study, participants will be monitored for clinical response, including the proportion achieving a 50% reduction in HS symptoms by week 16. Researchers will also evaluate safety and tolerability through regular assessments. The total study duration includes screening, treatment, and safety monitoring phases, allowing close observation of treatment effects and participant well-being.

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.

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating the safety and effectiveness of bimekizumab compared to a placebo in adults who have palmoplantar pustulosis (PPP), a skin condition affecting the palms and soles. This Phase 3 study aims to better understand how well bimekizumab works in treating PPP and to assess any safety concerns in participants with this condition. Participants will be randomly assigned to receive either bimekizumab or a matching placebo at specific scheduled times. The study includes a double-blind period where neither the participants nor the researchers know which treatment is being given. An open-label extension phase will follow, allowing all participants to receive bimekizumab to further evaluate its effects. During the study, participants will undergo assessments to measure the severity of their PPP, including the Palmoplantar Pustulosis Investigator Global Assessment (PPP-IGA) response at Week 16. Researchers will monitor skin symptoms, treatment safety, and overall health. The study involves regular visits and evaluations to track progress and any side effects over the course of the trial.

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 conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer affecting white blood cells, and it is the most common form of non-Hodgkin lymphoma. Follicular lymphoma (FL) is a slower-growing type of this lymphoma. This study aims to evaluate the real-world effectiveness of the investigational drug epcoritamab in adult patients with advanced DLBCL and FL. Around 700 participants will be enrolled across approximately 80 sites in 12 to 20 countries worldwide. Participants will receive epcoritamab as prescribed by their doctors according to the approved treatment guidelines in their country. The study does not add any extra treatments or procedures beyond what their doctors recommend. Participants will be followed for up to about 3 years to observe their responses to the treatment. During the study, participants will attend regular visits at hospitals or clinics as part of their standard care routine. Researchers will track the percentage of participants who achieve an overall response to treatment over the study period. There is no expected additional burden for participants beyond their usual clinical visits and treatments.