There are about 7997 clinical studies being (or have been) conducted in Japan. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.
This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations. The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.
The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected to assay PD-L1 expression and next generation sequencer (NGS) assay for tumor mutation burden (TMB).
This is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with inadequately controlled severe asthma.
To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.
Primary Objectives: - To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) - To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device - To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: - To estimate absolute bioavailability of SC and IV isatuximab - To measure receptor occupancy (RO) after isatuximab SC versus IV administration - To assess efficacy of isatuximab after SC and IV administration - To assess patient expectations prior to and patient experience and satisfaction after SC administration - To evaluate potential immunogenicity of SC or IV isatuximab
Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
Title: A single-center, retrospective randomized controlled trial of artificial intelligence (AI) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent upper gastrointestinal endoscopy. Précis: this single-center, retrospective randomized controlled trial will include 500 outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and will compare the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Objectives Primary Objective: to evaluate the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Secondary Objectives: to determine whether AI is not inferior to expert endoscopists in terms of the number of images analyzed for diagnosis of gastric cancer and intersection over union (IOU), and the detection rate of diagnosis of early and advanced gastric cancer. Endpoints Primary Endpoint: diagnosis of gastric cancer. Secondary Endpoints: image based diagnosis of gastric cancer and IOU. Population: in total, 500 males and females aged ≥ 20 years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a single hospital in Japan. Describe the Intervention: AI-based diagnosis of gastric cancer based on upper gastrointestinal endoscopy images. Study Duration: 3 months.