NCT04397263CompletedPhase 3
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 18 May 2020
- Start date
- 10 Jun 2020
- Primary completion date
- 29 Feb 2024
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Diseases
- Crohn's disease
- NCT number
- NCT04397263
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 38
- From 10 Jun 2020 to the primary completion date, 29 Feb 2024
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable doses of concomitant Crohn's disease therapy
- Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol
- Prior exposure to p40 inhibitors or p19 inhibitors
Other illness
- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
Other
- Any medical contraindications preventing study participation
Who the study is looking for
- Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
- Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
- Have screening laboratory test results within the protocol specified parameters
- A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
- Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KOKIKAI Tokatsu Tsujinaka Hospital Coordinator of this site? Confirm its status | Abiko | Japan | Unknown status |
| Institute of Science Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Hitachi General Hospital Coordinator of this site? Confirm its status | Hitachi | Japan | Unknown status |
| Asahikawa Medical University Hospital Coordinator of this site? Confirm its status | Hokkaido | Japan | Unknown status |
| Ofuna Chuo Hospital Coordinator of this site? Confirm its status | Kamakura | Japan | Unknown status |
| Kishiwada Tokushukai Hospital Coordinator of this site? Confirm its status | Kishiwada | Japan | Unknown status |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Japanese Red Cross Kumamoto Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Kyorin University Hospital Coordinator of this site? Confirm its status | Mitaka | Japan | Unknown status |
| Kenseikai Dongo Hospital Coordinator of this site? Confirm its status | Nara | Japan | Unknown status |
| Hyogo Medical University Hospital Coordinator of this site? Confirm its status | Nishinomiya-shi | Japan | Unknown status |
| Ishida Clinic of IBD and Gastroenterology Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| Kitasato University Hospital Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| Saitama Medical Center Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Sapporo Tokushukai Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Sendai Kosei Hospital Coordinator of this site? Confirm its status | Sendai Miyagi | Japan | Unknown status |
| Jichi Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuke | Japan | Unknown status |
| Tokyo Women's Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| National Center for Global Health and Medicine Coordinator of this site? Confirm its status | Shinjuku-Ku | Japan | Unknown status |
| Tokyo Metropolitan Bokutoh Hospital Coordinator of this site? Confirm its status | Sumida-ku | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| Toyama Prefectural Central Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Unknown status |
| National Hospital Organization Toyohashi Medical Center Coordinator of this site? Confirm its status | Toyohashi | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.