A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Crohns Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04397263
• Other study ID #: CR108801
• Secondary ID: CNTO1959CRD3003
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 10, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: June 1, 2025
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation

• 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

• Any medical contraindications preventing study participation

Related Conditions & MeSH terms

• Crohn Disease
• Crohns Disease

Intervention

Drug:
• Guselkumab
Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.

Locations

Country	Name	City	State
Japan	KOKIKAI Tokatsu Tsujinaka Hospital	Abiko
Japan	Tokyo Medical and Dental University Hospital	Bunkyo
Japan	Hitachi General Hospital	Hitachi
Japan	Asahikawa Medical University Hospital	Hokkaido
Japan	Ofuna Chuo Hospital	Kamakura
Japan	Kishiwada Tokushukai Hospital	Kishiwada
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyorin University Hospital	Mitaka
Japan	Kenseikai Dongo Hospital	Nara
Japan	Hyogo Medical University Hospital	Nishinomiya-shi
Japan	Ishida Clinic of IBD and Gastroenterology	Oita
Japan	Okayama University Hospital	Okayama-shi
Japan	Saga University Hospital	Saga
Japan	Kitasato University Hospital	Sagamihara
Japan	Saitama Medical Center	Saitama
Japan	Sapporo Tokushukai Hospital	Sapporo
Japan	Sendai Kosei Hospital	Sendai Miyagi
Japan	Jichi Medical University Hospital	Shimotsuke
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku
Japan	Tokyo Metropolitan Bokutoh Hospital	Sumida ku
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki
Japan	National Center for Global Health and Medicine	Tokyo
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	NHO Toyohashi Medical Center	Toyohashi

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	An Adverse Event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.	Up to Week 48
Secondary	Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score	The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with score ranges from 0 to approximately 600. A decrease over time indicates improvement in disease activity. .	Baseline to Week 48
Secondary	Change from Baseline in Patient-Reported Outcome (PRO)-2 Score	PRO-2 is based on unweighted CDAI components of the total number of liquid or very soft stools and the abdominal pain (AP) score. The PRO-2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.	Baseline to Week 48
Secondary	Change from Baseline in Simplified Endoscopic Score for Crohn's disease (SES-CD) Score	The SES-CD score will be used to evaluate endoscopic improvement based on presence/size of ulcers, mucosal surface covered by ulcers, mucosal surface affected by any other lesions, and presence/type of narrowing/structures) across 5 ileocolonic segments.	Baseline and Week 48
Secondary	Serum Concentation of Guselkumab	Serum concentration of Guselkumab will be reported.	Up to Week 48
Secondary	Number of Participants with Anti-Guselkumab Antibodies	Number of participants with anti-Guselkumab antibodies will be reported.	Up to Week 48
Secondary	Change from Baseline in C-reactive protein (CRP)	Change from baseline in C-reactive protein (CRP) will be reported.	Baseline and Week 4, 8, 12, 16, 20, 24, 32, 40 and 48
Secondary	Change from Baseline in Fecal Calprotectin (FC) Levels	Change from baseline in Fecal Calprotectin (FC) Levels will be reported.	Baseline and Week 4, 8, 12, 24 and 48