Danzhou, China
Fukushima
Recruiting
A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)
This study is a randomized, multicenter, double-blind, placebo-controlled phase 2 study (Part 1) followed by an open-label treatment period (Part 2) designed to evaluate the efficacy and safety of pacritinib for the prevention of VEXAS flares after glucocorticoid (GC) taper. The study will enroll patients ≥18 years with inflammatory VEXAS syndrome receiving ongoing GC therapy for ≥4 consecutive weeks, requiring between 15 and 45 mg daily (of prednisone / prednisolone or equivalent) at the time of enrollment (randomization). Patients will be randomized 1:1:1 to receive pacritinib dose A (n=26), pacritinib dose B plus placebo (n=26), or placebo (n=26) for up to 24 weeks during a double-blind treatment period, followed by treatment with pacritinib during an open-label treatment period for up to 48 weeks, and a 30-day post-End of Treatment (EOT) follow-up period. Randomization will be stratified by prescribed GC dose on the day of randomization. All outcomes will be reported by treatment arm, and pair-wise comparison between each pacritinib arm and placebo will be performed in the double-blind treatment period. Patients who complete the double-blind treatment period at End of Week 24 or meet Early Failure criteria at End of Week 12 will transition to an open-label pacritinib treatment period through End of Week 48. In addition, if a study arm closes due to interim futility or safety, all patients currently randomized to that arm will transition to open-label treatment. Study termination is planned approximately 1 year from the first dose of the last patient.
Phase
2Span
122 weeksSponsor
Swedish Orphan BiovitrumFukushima
Recruiting
ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Phase
3Span
346 weeksSponsor
Ono Pharmaceutical Co. LtdFukushima
Recruiting
A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
Phase
3Span
380 weeksSponsor
GlaxoSmithKlineFukushima
Recruiting
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
Phase
3Span
377 weeksSponsor
IpsenFukushima
Recruiting
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Phase
3Span
248 weeksSponsor
Merck Sharp & Dohme LLCFukushima
Recruiting
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Phase
3Span
693 weeksSponsor
Merck Sharp & Dohme LLCFukushima
Recruiting
A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
Phase
3Span
341 weeksSponsor
Bristol-Myers SquibbFukushima
Recruiting
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
Phase
2Span
222 weeksSponsor
Ono Pharmaceutical Co. LtdFukushima
Recruiting
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Phase
3Span
238 weeksSponsor
Ono Pharmaceutical Co. LtdFukushima
Recruiting