Takamatsu City, Japan
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Phase
1/2Span
360 weeksSponsor
Bristol-Myers SquibbOita
Recruiting
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Phase
2Span
177 weeksSponsor
Kowa Research Institute, Inc.Oita
Recruiting
Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
This is a mandatory Post-Marketing Surveillance (PMS) requested by Pharmaceuticals and Medical Devices Agency (PMDA) as a part of the Japan-Risk Management Plan (J-RMP).
Phase
N/ASpan
331 weeksSponsor
Astellas Pharma IncOita
Recruiting
Oita
Recruiting
A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis
Phase
3Span
197 weeksSponsor
Janssen Research & Development, LLCOita
Recruiting
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
Phase
3Span
201 weeksSponsor
Janssen Research & Development, LLCOita
Recruiting
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
Phase
2Span
110 weeksSponsor
Eli Lilly and CompanyOita
Recruiting
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting. The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Phase
N/ASpan
191 weeksSponsor
AstraZenecaOita
Recruiting
TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire. 1. Development of related AEs 2. Contributing factors possibly having an impact on the safety and effectiveness 3. Development of unexpected related AEs This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.
Phase
N/ASpan
346 weeksSponsor
AstraZenecaOita
Recruiting
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Phase
3Span
219 weeksSponsor
Hoffmann-La RocheOita
Recruiting