Langenau

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 the effectiveness of icotrokinra (JNJ-77242113) compared to a placebo in adults with active psoriatic arthritis (PsA). This study includes both participants who have previously used biologic treatments and those who have not. The goal is to assess how well the drug reduces the signs and symptoms of PsA by the 16th week of treatment. This is a Phase 3, multicenter, randomized, double-blind clinical trial designed to provide reliable evidence on the drug's impact on this condition. Participants will receive either icotrokinra or a placebo. The treatments will be administered according to the study protocol, but specific dosing details are not provided. Participants will be monitored over 16 weeks to evaluate their response to the treatment, focusing on the American College of Rheumatology (ACR) 20 response, which measures improvement in disease activity. The study compares the active drug against placebo to determine its efficacy and safety in this patient group. During the study, participants will undergo assessments to monitor their psoriatic arthritis symptoms, including joint swelling and tenderness, as well as blood tests to measure inflammation markers like C-reactive protein. Female participants who can become pregnant will have pregnancy tests before and during the study to ensure safety. Researchers will collect data on disease activity and safety throughout the study period to understand the treatment's effects. Total participation time and additional follow-up details are not specified.

Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

Researchers are conducting a prospective, non-interventional observational study to evaluate the long-term effects of dupilumab treatment in patients aged 6 years and older with atopic dermatitis (AD). The study aims to understand the characteristics of AD patients in Germany who receive dupilumab under everyday conditions, including their medical history, socio-demographic and disease-related features, associated atopic comorbidities and type 2 inflammation diseases, as well as their previous and ongoing AD treatments. The study will also assess therapeutic response rates at Month 6 and long-term efficacy at Months 12 and 24 by measuring disease control with tools such as the Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). Additionally, the study will observe dosing patterns, reasons for treatment changes, and collect long-term safety data. Participants will receive dupilumab treatment as part of their routine care without any intervention from the study. The observation period for each participant lasts up to 2 years or until dupilumab treatment is discontinued. Visits will be scheduled according to the standard of care, and the study will collect data on variations in dosing regimens, treatment initiation or discontinuation reasons, and concomitant therapies. During the study, participants or their guardians will complete questionnaires to assess signs, symptoms, quality of life, and disease control related to atopic dermatitis. Researchers will monitor outcomes such as the number of patients maintaining controlled disease states between Months 6 and 12, and changes in ADCT and RECAP scores over 52 weeks. Safety data will also be collected throughout the observation period to evaluate the long-term effects of dupilumab in both adult and pediatric patients.

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 evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 trial focuses on participants with mild to moderate HS who have had the condition for at least six months. The study aims to see how well the cream works in reducing HS symptoms compared to a placebo cream (vehicle cream). Participants will be randomly assigned to apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily on affected areas. The study specifically includes those with a certain number of abscesses and nodules but no draining tunnels, affecting at least two different body areas. The study also requires participants to avoid using antibiotics or antiseptic products on affected areas during the vehicle-controlled period and part of an extension phase. During the study, researchers will monitor participants closely through assessments of the skin condition and safety checks. They will measure the proportion of participants who achieve a significant clinical response by week 16. The total body surface area treated must not exceed 20%, and participants will be followed to ensure adherence and safety throughout the trial period.