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Study to evaluate HZN-825 in patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial for HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1). Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. Participants who complete the Double-blind Treatment Period (Week 52) may be eligible to enter a 52-week extension trial (HZNP- HZN-825-302). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.
Phase
2Span
139 weeksSponsor
Horizon Therapeutics Ireland DACNagasaki-Shi
Recruiting
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Phase
3Span
575 weeksSponsor
Janssen Research & Development, LLCNagasaki
Recruiting
Nagasaki
Recruiting
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
Phase
3Span
258 weeksSponsor
Bristol-Myers SquibbNagasaki
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
AstraZenecaNagasaki
Recruiting
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
Phase
N/ASpan
251 weeksSponsor
Hoffmann-La RocheNagasaki
Recruiting
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Phase
3Span
162 weeksSponsor
Immunovant Sciences GmbHNagasaki
Recruiting
Nagasaki
Recruiting
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions. 1. Detection of unknown adverse drug reactions 2. Incidence of adverse drug reactions under actual use conditions of the drug 3. Factors that may affect the safety or effectiveness "Safety specification" Thrombotic events, Infusion reaction, re-bleeding
Phase
N/ASpan
157 weeksSponsor
AstraZenecaNagasaki
Recruiting
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Phase
3Span
242 weeksSponsor
Janssen-Cilag Ltd.Nagasaki
Recruiting