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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Crohns Disease
• Intervention / Treatment: Drug: Guselkumab

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Japan
  • Abiko, Japan, 270-1168
    • KOKIKAI Tokatsu Tsujinaka Hospital
  • Bunkyo, Japan, 113-8519
    • Tokyo Medical and Dental University Hospital
  • Hitachi, Japan, 317-0077
    • Hitachi General Hospital
  • Hokkaido, Japan, 078-8510
    • Asahikawa Medical University Hospital
  • Kamakura, Japan, 247-0056
    • Ofuna Chuo Hospital
  • Kishiwada, Japan, 5960042
    • Kishiwada Tokushukai Hospital
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kumamoto, Japan, 861-8520
    • Japanese Red Cross Kumamoto Hospital
  • Mitaka, Japan, 181-8611
    • Kyorin University Hospital
  • Miyagi, Japan, 9800873
    • Sendai Kosei Hospital
  • Nara, Japan, 635-0022
    • Kenseikai Dongo Hospital
  • Nishinomiya, Japan, 663-8501
    • The Hospital of Hyogo College of Medicine
  • Oita, Japan, 8700823
    • Ishida Clinic of IBD and Gastroenterology
  • Okayama-shi, Japan, 700-8558
    • Okayama University Hospital
  • Saga, Japan, 849-8501
    • Saga University Hospital
  • Sagamihara, Japan, 252-0375
    • Kitasato University Hospital
  • Saitama, Japan, 350 8550
    • Saitama Medical Center
  • Sapporo, Japan, 004-0041
    • Sapporo Tokushukai Hospital
  • Shimotsuke, Japan, 329-0498
    • Jichi Medical University Hospital
  • Shinjuku-ku, Japan, 162-8666
    • Tokyo Women's Medical University Hospital
  • Sumida-ku, Japan, 130-8575
    • Tokyo Metropolitan Bokutoh Hospital
  • Takatsuki, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Tokyo, Japan, 162-8655
    • National Center for Global Health and Medicine
  • Toyama, Japan, 9308550
    • Toyama Prefectural Central Hospital
  • Toyohashi, Japan, 441-8570
    • NHO Toyohashi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guselkumab; Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab.	Drug: Guselkumab; Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.; Other Names: CNTO1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Serum Concentation of Guselkumab	Serum concentration of Guselkumab will be reported.	Up to Week 48
Number of Participants with Anti-Guselkumab Antibodies	Number of participants with anti-Guselkumab antibodies will be reported.	Up to Week 48
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
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

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.
• Investigators: Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: CR108801; CNTO1959CRD3003 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes