Otsu

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 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.

Researchers are evaluating the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA, both given as subcutaneous (SC) infusions, for maintenance treatment of adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). This Phase 3 trial includes participants who have previously received intravenous or subcutaneous immunoglobulin G treatments and aims to compare these two therapies' behavior in the body. Participants must have a confirmed diagnosis of CIDP and have responded to IgG treatment before, consistent with established diagnostic criteria. The study consists of multiple phases: screening, a ramp-up phase if needed, a HYQVIA treatment phase, a TAK-881 treatment phase, and finally, an extension phase. Participants who previously received conventional subcutaneous or intravenous immunoglobulin will start with a HYQVIA ramp-up phase 1 to 2 weeks after their last dose. Those already on HYQVIA proceed straight to treatment. Participants receive SC infusions of HYQVIA for 20 weeks, then switch to TAK-881 for 24 weeks. During the extension phase, home infusions are preferred, with clinic visits spaced between 12 and 24 weeks. Throughout the study, participants visit the clinic every 3 or 4 weeks during the initial phases. Researchers will monitor immunoglobulin G levels through blood tests at specified intervals to assess drug exposure. Safety and treatment adherence are tracked, and participants complete disability assessments. The total duration includes these treatment phases and the extension, with careful follow-up to evaluate the therapies' pharmacokinetic profiles and participant well-being.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years who have severe uncontrolled asthma. These children must be on medium to high doses of inhaled corticosteroids along with at least one other asthma controller medication, with or without oral corticosteroids. This phase 3, multicenter, double-blind, placebo-controlled study aims to better understand how tezepelumab affects asthma control in this pediatric population. Participants will be randomly assigned in a 2:1 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo for 52 weeks during the double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in phase. After the treatment period, a 12-week follow-up phase occurs without treatment. Eligible participants can then join an optional open-label extension, receiving tezepelumab for an additional 104 weeks followed by another 12-week post-treatment follow-up. Throughout the study, participants will have regular assessments including lung function tests, asthma control questionnaires, and monitoring for asthma exacerbations. Researchers will measure the annualized rate of severe asthma flare-ups from the start of treatment to week 52. Safety and treatment adherence will also be closely monitored during all study phases, with total participation potentially extending over two years for those in the extension period.

Researchers are evaluating how the study medicine PF-06823859 (dazukibart) works in adults with active idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM). These rare diseases cause muscle inflammation that weakens muscles important for movement, and DM may also cause a characteristic skin rash. The study aims to understand the safety and effectiveness of dazukibart compared to placebo in this patient group. Participants will receive either the study medicine or a placebo, both given as intravenous (IV) infusions lasting about 1 hour. These infusions will be administered every 4 weeks from the first day up to Week 48 at the study site. The study includes a total duration of about 13 months with 15 visits to the study site for treatment and monitoring. During the study, participants will be monitored through regular visits where researchers will assess their health and response to treatment. The main outcome measured is the moderate change in the Total Improvement Score (TIS) at 24 weeks for sites outside the United States and at 52 weeks for sites within the United States. Safety and other health evaluations will be conducted throughout the study to understand how participants respond to the study medicine compared to placebo.

This trial investigates the efficacy and safety of SEP-363856 (Ulotaront) in adults aged 18 to 65 experiencing acute psychotic episodes related to schizophrenia. It is a Phase 3, randomized, double-blind, placebo-controlled, and multicenter study designed to evaluate treatment effects in participants undergoing symptom relapse or exacerbation within two months before screening. The study focuses on individuals requiring hospitalization for these symptoms and assesses changes in psychosis severity. Participants are randomly assigned to receive either SEP-363856 tablets or placebo tablets during the treatment period. The study design includes parallel groups to compare outcomes between the investigational drug and placebo. Treatment duration and dosing details are consistent with the study protocol but are not specified in this summary. Throughout the study, researchers monitor participants using the Positive And Negative Syndrome Scale (PANSS) to measure changes in symptom severity from baseline to Week 6. Additional assessments include Clinical Global Impression-Severity (CGI-S) scores and safety evaluations. The total study period includes screening, treatment, and follow-up to ensure comprehensive monitoring of efficacy and safety in acutely psychotic individuals with schizophrenia.

Parkinson's disease (PD) is a neurological disorder that affects the brain and causes symptoms like tremors, stiffness, and slow movements. This research aims to evaluate how safe and effective ABBV-951 is when used to treat adults with advanced Parkinson's disease in a real-world setting. ABBV-951 is an approved medication in Japan, and the study will involve about 250 adult participants aged 15 years and older who have been diagnosed with PD and prescribed ABBV-951 by their doctors. Participants will receive ABBV-951 as directed by their physicians over a period of 52 weeks. The study will observe and record any changes in disease activity as well as any adverse events that occur, including monitoring the percentage of participants experiencing infusion site infections during this time. The treatment and follow-up will be conducted either in-person or through virtual visits according to standard care practices. During the study, participants will have regular visits and assessments, which may be conducted on-site or virtually, ensuring minimal additional burden. Researchers will collect data on safety and effectiveness throughout the 52-week period. The study is designed to monitor participants closely while allowing treatment as usual, supporting ongoing evaluation of ABBV-951 in managing advanced Parkinson's disease.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

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 evaluating ABBV-RGX-314, a novel one-time gene therapy, for treating neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD causes vision loss due to abnormal blood vessel growth in the retina and affects millions in the United States, Europe, and Japan. Current treatments require frequent eye injections, which can be burdensome and may lead to reduced vision over time. This Phase 3 study aims to compare the effectiveness and safety of two doses of ABBV-RGX-314 against the standard anti-VEGF drug, aflibercept, in people with wet AMD. Participants will be randomly assigned to receive one of two doses of ABBV-RGX-314 gene therapy or aflibercept injections. The gene therapy involves a one-time subretinal injection delivering a gene that produces an anti-VEGF protein to help control abnormal blood vessels. In addition, a bilateral treatment substudy will examine safety and effectiveness when both eyes are treated in participants with wet AMD in both eyes. This substudy will enroll up to 15 participants for at least 50 weeks of follow-up. During the study, participants will have their vision measured regularly to assess changes in best-corrected visual acuity (BCVA). Safety will be monitored by recording any eye-related adverse events and serious side effects. Participants will be followed for up to 54 weeks or more to evaluate how well the gene therapy maintains or improves vision compared to aflibercept and to assess overall treatment safety and tolerability.