Bad Bentheim

Researchers are evaluating the effectiveness of delgocitinib cream 20 mg/g applied twice daily compared to a cream vehicle in treating adults with mild to severe palmoplantar pustulosis (PPP). This phase 2a, double-blind, two-arm trial focuses on adults diagnosed with PPP, a condition characterized by persistent pustules on the palms and/or soles, lasting more than three months. The study aims to assess skin improvement using the PPP Area and Severity Index (PPPASI) and other clinical evaluations over 16 weeks. Participants will be randomly assigned to apply either delgocitinib cream or the cream vehicle twice daily during a 16-week treatment period. The study involves approximately 9 visits over about 18 weeks in total. The trial is designed to compare the two treatments' effects on PPP severity, with a thorough monitoring process throughout the study period. During the trial, participants will undergo clinical assessments including photographic evaluations to confirm PPP diagnosis, PPPASI scoring to measure skin improvement, and physician global assessments. Safety and treatment adherence will be closely monitored. The main outcome measure is the number of participants achieving at least a 75% improvement in PPPASI score from baseline at week 16. The study also includes safety checks and follow-up to ensure participant well-being throughout the trial.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are studying the dose-response effects of galvokimig compared with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition lasting at least one year. The study focuses on adults aged 18 years and older who have significant disease activity as measured by specific clinical scores and a history of inadequate response to topical treatments or contraindications to them. This phase 2 trial aims to evaluate the safety, effectiveness, and how the drug behaves in the body. Participants will receive either galvokimig or a placebo as an injection. The study uses a randomized, double-blind, placebo-controlled design with multiple doses tested in parallel groups. Treatments are given as solutions for injection, and the study monitors participants over a defined period to assess how the drug works and its safety profile. During the study, participants will undergo assessments including clinical scoring of their skin condition such as the Eczema Area and Severity Index at week 16 to measure response. Researchers will also monitor safety through physical exams, laboratory tests, and medical history reviews. The study requires stopping other systemic or topical treatments before starting and tracks participant adherence and outcomes carefully throughout the study duration.

Researchers are evaluating the effects, safety, and response to the medicine zasocitinib in children and teenagers aged 4 to under 18 years who have moderate-to-severe plaque psoriasis. The study is designed in two parts, with Part A including both children and teenagers and Part B including only children. Initially, only teenagers meeting the study criteria can join, with children joining later after more data is collected from other studies. In Part A, participants are randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all receive zasocitinib for the rest of the study. Participants in Part B receive zasocitinib throughout. The treatment period lasts up to 208 weeks, followed by a 4-week safety follow-up. Both drug and matching placebo are used, and the study is conducted at multiple centers. Participants will attend multiple visits to the study site over a total duration of up to 4 years and 2 months, including a screening period of up to 35 days. Researchers will assess improvements in psoriasis severity using measures like the Static Physician's Global Assessment and Psoriasis Area and Severity Index at week 16. In Part B, they will also study how the body absorbs and processes zasocitinib by measuring drug levels at specific times. Safety and tolerability will be monitored throughout the study.

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 safety and effectiveness of baricitinib, a medication taken by mouth, for treating severe or very severe alopecia areata, a type of hair loss, in children aged 6 to less than 18 years. This Phase 3 study involves children and adolescents who have had alopecia areata for at least one year and are experiencing a current episode lasting at least six months with significant hair loss. The study aims to see how well baricitinib works compared to a placebo. The study is divided into four distinct periods: a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive either baricitinib or placebo, an approximately 2-year long-term extension period for continued treatment, and a 4-week post-treatment follow-up period to monitor participants after stopping the medication. Both baricitinib and placebo are administered orally. Participants will undergo various assessments throughout the study, including measuring the severity of hair loss using the Severity of Alopecia Tool (SALT) score. The main outcome is the percentage of participants achieving a SALT score of 20 or less after 36 weeks of treatment. Safety and pharmacokinetics of baricitinib will also be monitored during the study. The total participation may last over two years, including treatment and follow-up phases.

Researchers are evaluating the safety and effectiveness of KT-621, an oral drug, in adults and adolescents aged 12 to 75 years with moderate-to-severe atopic dermatitis (AD), a common form of eczema. This phase 2b study aims to assess how well KT-621 reduces the severity and extent of AD, its safety and tolerability, how the drug behaves in the body, and the body's response to the drug. The study includes a 16-week double-blind, placebo-controlled period followed by a 52-week open-label phase. Participants will receive either KT-621 or a matching oral placebo during the initial 16-week double-blind period. Following this, all participants have the option to enter a 52-week open-label period where they receive KT-621. During these phases, participants will continue their regular use of moisturizers twice daily and adhere to the treatment plan. The study is conducted across multiple centers and includes dose-ranging to evaluate different doses of KT-621. Throughout the study, participants will have scheduled visits for assessments including clinical evaluations of eczema severity using the Eczema Area and Severity Index (EASI) score, which measures changes from baseline through week 16. Other evaluations include questionnaires, laboratory tests, and adherence monitoring via an electronic diary. Safety and tolerability are closely monitored, and participants are expected to comply with all study procedures over the entire duration of the trial, including both the double-blind and open-label periods.

Hidradenitis Suppurativa (HS) is a skin condition causing deep, painful bumps that appear where skin rubs together. These bumps can swell, become red, and sometimes fill with pus, turning into abscesses that may burst. Over time, HS can lead to scars and tunnels on or under the skin. This study aims to evaluate how safe and effective the drug zasocitinib is for adults with moderate to severe HS, comparing it to a placebo in a Phase 2 trial. Participants will receive either zasocitinib or a placebo capsule daily for 16 weeks. The placebo looks the same but contains no medicine. After this initial 4-month period, all participants, including those who first received placebo, will be offered zasocitinib for up to an additional 8 months. Throughout the study, participants will visit the clinic 12 times for treatment and monitoring. During the visits, researchers will assess treatment response, including the percentage of participants achieving a 75% reduction in HS signs at week 16. They will also monitor safety and tolerance of the medication. Participants will undergo various evaluations such as physical exams, lab tests, and questionnaires to track disease progress and side effects. The study includes careful follow-up to ensure participant safety and to gather detailed information on the drug's effects over the total study duration of up to 12 months.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

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.