Iiduka, Japan
A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis
This trial will have 3 parts plus screening and follow-up parts: - Parts A and B: Participants will either be included in part A or B. Each is a 24-week double-blind (this means none of the participants, doctors, or other trial staff will know what treatment each participant took) part where participants will receive either dupilumab or a placebo (a placebo looks like a trial drug but does not have any medicine in it). - Part C: 28-week extension part that will include participants from parts A and B and all participants will receive dupilumab
Phase
2/3Span
225 weeksSponsor
Regeneron PharmaceuticalsIizuka, Fukuoka
Recruiting
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
302 weeksSponsor
Bristol-Myers SquibbIizuka, Fukuoka
Recruiting
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Phase
3Span
217 weeksSponsor
Karuna TherapeuticsIizuka, Fukuoka
Recruiting
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Phase
3Span
111 weeksSponsor
Karuna TherapeuticsIizuka, Fukuoka
Recruiting
A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years
Invasive extraintestinal pathogenic Escherichia coli disease (IED) is defined as an acute illness consistent with systemic bacterial infection, which is microbiologically confirmed either by the isolation and identification of Escherichia coli (E. coli) from blood or any other sterile body sites, or by the isolation and identification of E. coli from urine in a participant with urosepsis and no other identifiable source of infection. ExPEC9V (JNJ-78901563, primary compound number: VAC52416) is a 9-valent vaccine candidate in development for active immunization for the prevention of IED in adults 60 years of age and older. Although IED affects all ages, adults aged greater than or equal to (>=) 60 years have an increased risk of developing IED, including bacteremia and sepsis, which can be community-acquired, hospital-acquired or healthcare associated. As the mechanism of action of conjugate vaccines in the prevention of invasive disease is not expected to be affected by antibiotic resistance mechanisms, that is, resistance mechanisms are not linked to O-polysaccharide structures, the sponsor has no reason to expect a difference in outcome of efficacy between antimicrobial-resistant and susceptible O-serotypes. This study incorporates an inferentially seamless group-sequential design. This study consists of a Screening Phase (selected screening procedures may be performed up to 8 days prior to vaccination on Day 1), Randomization, Vaccination Phase (Day 1) and Follow-up Phase (up to 4 years post-vaccination). The total study duration is approximately up to 6 years 9 months. Key safety assessments include serious adverse events (SAEs), solicited and unsolicited adverse events (AEs), physical examination, and vital signs.
Phase
3Span
217 weeksSponsor
Janssen Research & Development, LLCIizuka
Recruiting
Healthy Volunteers
Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
Phase
3Span
155 weeksSponsor
Kringle Pharma, Inc.Iizuka, Fukuoka
Recruiting