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Researchers are evaluating the long-term safety of subcutaneous guselkumab injections in children with moderately to severely active ulcerative colitis, Crohns disease, or juvenile psoriatic arthritis. This Phase 3 study focuses on pediatric participants who have previously been treated with guselkumab and will continue therapy in this extension study to monitor safety over an extended period. Participants who completed dosing in one of three primary pediatric guselkumab studies and are deemed by their investigator to benefit from continued treatment will join this long-term extension. Guselkumab is administered as a subcutaneous injection either every 8 weeks or every 4 weeks, depending on prior study assignment and clinical status. Some participants may switch dosing frequency once during the extension before unblinding, after which dosing aligns with their original regimen. Dose adjustments are restricted based on the primary study they came from. During the study, participants will receive guselkumab injections regularly and be monitored for treatment-emergent adverse events for up to nearly seven years. Researchers will assess safety outcomes through ongoing clinical evaluations over this time. Parents or legal representatives provide consent for children to participate, and children capable of understanding the study will give assent. The total participation duration may extend up to six years and nine months, allowing long-term safety data collection.

Researchers are evaluating the effectiveness of E6742 tablets in adults aged 18 to 75 years with systemic lupus erythematosus SLE. This Phase 2 trial aims to compare different doses of E6742 with a placebo by measuring the proportion of participants who achieve a response using the BILAG-based Composite Lupus Assessment BICLA while on a low dose of oral corticosteroids at Week 24. The study focuses on improving disease control in SLE patients under stable treatment conditions. Participants will be randomly assigned to one of four groups receiving either placebo or one of three different doses of E6742 oral tablets. The treatment period lasts 24 weeks, during which participants continue their standard SLE treatments at stable doses. The study includes careful monitoring of responses and safety through various assessments, including laboratory tests and clinical evaluations. During the trial, participants will undergo regular evaluations to measure disease activity, side effects, and drug levels. Assessments include the BILAG-2004, SLEDAI-2K, electrocardiograms, ophthalmic exams, chest X-rays, and patient-reported outcomes. Safety is monitored throughout the 52-week period, with detailed tracking of adverse events and laboratory parameters. Participants will be involved in scheduled visits and assessments to understand the drugs effects and tolerability over time.

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Researchers are evaluating how well vortioxetine, given at doses of 10 mg or 20 mg per day, works compared to a placebo to treat depression symptoms in Japanese teenagers aged 12 to 17 years diagnosed with Major Depressive Disorder MDD. The study focuses on assessing both the effectiveness and side effects of vortioxetine in this young population. Participants will take the study drug orally once daily for 14 weeks. The initial dose of vortioxetine starts at 10 mg per day and may be increased to 20 mg per day based on the study plan. Some participants will receive vortioxetine while others will receive a placebo, and the trial is randomized and double-blind to fairly compare outcomes. During the approximately 20-week study, participants will first spend up to 2 weeks screening for eligibility, then take vortioxetine or placebo for 14 weeks, followed by a 4-week period to monitor any side effects after treatment ends. Participants will visit their clinic 13 times for assessments, which include rating scales for depression symptoms and other health evaluations. Researchers will monitor changes in depression severity using tools like the Children Depression Rating Scale and assess safety through clinical observations and tests.

Crohns Disease CD is a digestive condition causing symptoms like chronic diarrhea, abdominal pain, weight loss, and fever. This research evaluates the pharmacokinetics, safety, and effectiveness of risankizumab in children aged 2 to under 18 years with moderately to severely active CD who have not responded well or cannot tolerate other treatments. Risankizumab is already approved for adults with certain inflammatory conditions and is now being studied for pediatric CD. The study includes three groups based on age, enrolling children from 2 to less than 18 years old. It has three parts an open-label 12-week induction phase where participants receive intravenous risankizumab based on their weight, a 52-week double-blind maintenance phase with subcutaneous risankizumab at one of two doses, and a 208-week open-label extension phase where treatment continues based on earlier responses. Participants who complete each phase may continue to the next, with dosing adjusted by age group. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, and questionnaires to monitor disease activity, side effects, and drug levels. Researchers will measure outcomes such as clinical remission and endoscopic response at 12 and 64 weeks, along with drug concentration in the blood. The total follow-up after treatment lasts about 140 days, with long-term monitoring during the extension phase.

Researchers are investigating atumelnant in adults aged 18 to under 75 years with classic congenital adrenal hyperplasia CAH caused by 21-hydroxylase deficiency 21-OHD. This Phase 3, global, randomized, double-blind, placebo-controlled study aims to assess the effectiveness, safety, pharmacokinetics, and pharmacodynamics of atumelnant in participants who have been on stable glucocorticoid GC therapy for at least two months. Eligible participants enter a screening period lasting 3 to 6 weeks to confirm suitability for the study. After screening, participants are randomly assigned in a 21 ratio to receive either 80 mg of atumelnant orally once daily, with a possible dose increase to 120 mg at Week 20, or a matching placebo once daily for 32 weeks. The study compares these two groups to evaluate the effects of atumelnant alongside usual GC treatment. During the study, participants will have regular assessments including blood tests to measure hormone levels such as androstenedione A4 and 17-hydroxyprogesterone 17-OHP at baseline and specified weeks. Researchers will monitor participants hormone control, GC doses, safety, and adherence. The main outcome is the proportion of participants achieving morning post-GC A4 levels within the normal range while on physiologic GC replacement at Week 32. The total participation duration includes the screening and 32-week treatment periods.

Researchers are studying the drug JNJ-88545223 to see how well it works compared with a placebo in adults who have active psoriatic arthritis PsA. This study aims to determine if JNJ-88545223 can reduce the signs and symptoms of PsA and improve the health of joints and skin. The trial is a randomized, double-blind phase 2b study designed to evaluate different doses of the drug. Participants will be randomly assigned to receive one of four treatments from Week 0 to Week 16 placebo, or one of three doses of JNJ-88545223. Each group will receive their assigned treatment under blinded conditions to compare the effects. The study focuses on evaluating the efficacy and safety of these doses over the 16-week treatment period. During the study, participants will undergo regular assessments to measure treatment effects, including the American College of Rheumatology ACR 50 response at Week 16 as the primary outcome. Additional evaluations include skin severity indexes PASI responses, physical function questionnaires, and quality of life surveys. Safety and symptoms will be monitored throughout the trial, which lasts approximately 16 weeks for each participant.

Researchers are evaluating the safety and effects of a medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. The study focuses on adults aged 18 to 70 who have had asthma for at least 12 months and have been on regular maintenance treatments. Asthma is a condition that makes breathing difficult and can reduce quality of life and daily functioning. Participants will receive either PF-07275315 or a placebo through multiple injections under the skin during clinic visits over a 12-week period. The study is randomized and blinded, meaning neither participants nor researchers know who receives the medicine or placebo. The trial includes several experimental groups receiving different doses of PF-07275315 and a group receiving placebo to compare safety and effects. The study includes a 12-week treatment phase. During about 7.5 months of involvement, participants will attend nine clinic visits. Researchers will monitor lung function using tests like forced expiratory volume in 1 second FEV1, record any side effects or adverse events, and assess asthma control and quality of life through questionnaires. Safety will be followed for 24 weeks, including lab tests, vital signs, and heart monitoring. This helps understand how PF-07275315 affects lung function and overall health in asthma patients.

Researchers are evaluating the oral drug TEV-56286 for treating adults aged 30 to 75 with Multiple System Atrophy MSA, a rare and progressive neurological disorder. This Phase 2, double-blind, placebo-controlled study aims to assess the drugs effectiveness, safety, and tolerability over 56 weeks, including screening, treatment, and follow-up. The study includes participants considered clinically possible or probable MSA based on specific criteria and is conducted across multiple countries. Participants will be randomly assigned to receive either TEV-56286 capsules or a matching placebo once daily by mouth during a 48-week double-blind treatment period. Before treatment, they undergo up to 4 weeks of screening, and after treatment, a follow-up visit occurs about 4 weeks later. The study spans approximately 27 months in total. During the trial, participants will have regular assessments including neurological and physical exams, clinical rating scales such as the Modified Unified Multiple System Atrophy Rating Scale UMSARS, MRI scans to measure brain structures, walking tests, and quality-of-life questionnaires. Researchers will monitor for treatment-emergent side effects and collect safety data through vital signs, lab tests, and ECGs. The main outcomes focus on changes in MSA symptoms and disease progression from baseline to week 48.

Researchers are evaluating the pharmacokinetics, pharmacodynamics, efficacy, and safety of intravenous anifrolumab compared with placebo in children aged 5 to under 18 years with moderate to severe active systemic lupus erythematosus SLE who are receiving standard care. This phase III clinical trial aims to better understand how anifrolumab works and its effects in this pediatric population. Participants are randomly assigned to receive either anifrolumab or matching placebo via intravenous infusion every 4 weeks. The study includes several periods Part A is a 4-week double-blind pharmacokinetic phase Part B is a 48- to 52-week double-blind safety and efficacy phase Part C is a 52-week open-label extension and Part D involves a safety follow-up visit 12 weeks after the last dose. During the approximately 116-week study, participants undergo screening for up to 30 days, followed by regular infusions and assessments including blood tests to measure drug levels and immune markers. Researchers evaluate responses using disease activity scores and track safety throughout. The study concludes with a safety follow-up visit to monitor participants after completing treatment.