Kouhoku, Japan

Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

This is a multicenter, open label, Phase 2b study of the selective inhibitor of nuclear export (SINE) selinexor (40 or 60 milligrams [mg]) given orally (PO) to participants with R/R DLBCL). The study is being conducted in 2 parts (Part 1 and Part 2). For Part 1, a fixed 60 mg dose of selinexor is given orally to 130 participants with R/R DLBCL who have no therapeutic options of demonstrated clinical benefit and who meet eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred. For Part 2, approximately 110 participants (55 in each arm) are planned to be enrolled. Participants will be randomized (open label) in a 1:1 ratio to either Arm A (40 mg) or Arm B (60 mg) and will be stratified based on history of prior autologous stem cell transplantation (ASCT) versus no prior ASCT. All the participants will be followed until disease progression and/or death.

R-3750 in Patients with Mild to Moderate Ulcerative Colitis

Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19

This is a clinical trial to evaluate the safety, PK, viral shedding and efficacy of PentarlandirTM UPPTA as a treatment for patients with early COVID-19. Approximately 90 ambulatory subjects with mildly symptomatic early COVID-19, who have been diagnosed with COVID-19 within the prior 48 hours, will be enrolled in the proof of principle study. Upon signing informed consent and evaluating medical history, concomitant medications, oxygen saturation (SaO2) at room air and vital signs, a focused physical examination of the heart and lungs will be performed. Subjects will be randomized into High-Dose, Low-Dose, and Placebo group in a 1:1:1 ratio at the final sample, but the enrollment will be staggered. In the first phase, 45 study subjects will be randomized at 2:1 ratio to Pentarlandir™ UPPTA low dose or placebo. After all the forty-five (45) subjects have completed the Day 21 assessment or early terminated (14-day dosing and 7 days of followed-up), DSMB will review the safety from the cohort and provide concurrence with proceeding with the higher dose cohort. If DSMB deems that the study is safe to proceed, another 45 subjects will be randomized at 2:1 ratio to Pentarlandir™ UPPTA high dose or placebo in the second phase. Both staggered cohorts will have the same stopping rules. During both phases of study, specimens for quantification of the viral genome, inflammatory markers, and safety laboratory tests will be collected. The IP will be dispensed to the study subjects and the subject will take the first dose of the study treatment at the clinic. Study subjects will be instructed (and provided) to use a device for ePRO for how to complete the patient-reported diary. The subjects will take the IP orally. Subjects in the low-dose group will take from each bottle of the active drug and placebo every 8 hours (q8h); for the high-dose group, from each of the two bottles of active drug; and for the placebo group, from each of the two bottles of placebo for 14 days. The first treatment dose should be taken within 4 days of COVID-19 diagnosis. Physical examination, specimen collection, laboratory evaluations and urine pregnancy test, vital signs, pulse oxygen saturation and clinical symptom and status determination will be conducted. Subjects who meet the eligibility criteria will be randomized. All subjects who fail to meet eligibility criteria are considered screen failures and are exited from the study without further evaluation. Screening and Randomization (V1, Day 1): After determining the eligibility, the study subjects will be randomized 2:1 to Pentarlandir™ UPPTA (either low or high dose) or placebo. The IP for treatment period will be dispensed to the study subjects and the subject will take the first dose of the study treatment at the study site. Study subjects will be instructed (and provided) how to complete the electronic patient reported outcome (ePRO) on a device. Treatment Period (V2 - V14 (EOT), Day 2 - Day 14): The subjects will continue to document the daily diary of ePRO. Total 13 visits are included in this period. Except 4 in-persons visits (V3, V7, V10, and V14), no in-person visit is expected during the study. Subjects will return to the clinical study sites to collect specimens for quantification of viral genome, inflammatory markers, pharmacokinetic and safety laboratory tests as well as record the SaO2, oral temperature, heart and respiratory rate, blood pressure, symptoms and concomitant medications, to document clinical status and adverse events (AEs), and IP accountability will be monitored. In addition, clinical symptom assessments and 7-category ordinal scale will be evaluated as well along with safety laboratory evaluations to determine whether the subject will continue to take the IP or stop the clinical trial. The subject will return the study treatment bottles at EOT visit. Except for the in-person visits, subjects will be phone-called once every day between 8:00 AM and 7:00 PM on the visits to record concomitant medications and to document clinical status and 7-category ordinal scale as well as adverse events (AEs) to determine whether the subject will be taken of the IP and/or stop the clinical trial. Weekly Follow-Up Period (V15 - V20, Day 15 - Day 56): Between Day 15 to 28, subjects will perform the ePRO diary daily. In addition to ePRO, study subjects will be called every 7±2 days after EOT visit to document final outcome and AEs up to Day 56. AE/SAEs, hospital and ICU lengths of stays, and mortality in hospitalized subjects will be documented.

A Clinical Investigation Evaluating Wound Closure with OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's

A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

Primary objectives This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage F2 or F3 and consists of 2 sequential parts - an initial double-blind placebo-controlled (DBPC) period (Part A) followed by a double-blind active treatment extension (ATE) period (Part B), with the following primary objectives: Part A To assess the safety and efficacy of lanifibranor compared to placebo on 'NASH resolution and improvement of fibrosis' assessed by liver histology. Part B To assess the safety of lanifibranor beyond the DBPC period. Secondary objectives Key secondary objectives of Part 1: - To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis - To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH Other secondary objectives of both Part 1 and Part 2: - To assess the effect of lanifibranor on other key histological features of NASH (only for DBPC period) - To assess the effect of lanifibranor on NASH resolution and improvement of fibrosis in diabetic patients (only for DBPC period) - To assess the effect of lanifibranor on liver tests - To assess the effect of lanifibranor on glycaemic parameters - To assess the effect of lanifibranor on lipid parameters - To assess the effect of lanifibranor on liver stiffness and steatosis assessed by elastography. - To assess the effect of lanifibranor on health-related quality of life - To assess the safety of lanifibranor - To assess population PK modeling through plasma levels of lanifibranor using sparse sampling scheme (only for DBPC period)

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

This study includes 5 substudies: Substudy A - Phase 2: A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in participants with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3. Substudy 1 - Phase 2: A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3. Substudy 2 - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy. Substudy 3 - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy. Participants from Substudy 1 and Substudy 2 will be enrolled in Substudy 3. Substudy 4 - Long-Term Extension: A long-term extension substudy for participants who complete at least 52 weeks of treatment. Participants from Substudy 3 and Substudy A are planned to be enrolled in Substudy 4.

R-5280 in Newly Diagnosed Patients with Type 1 Diabetes

Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents

A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma

An INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY to ASSESS the PERFORMANCE of the CORDIO HEARO SYSTEM

Two periods: Run-In period will be a period in which patients will submit daily recordings, baseline creation Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.