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

Primary Purpose

Crohns Disease

Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Guselkumab
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohns Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KOKIKAI Tokatsu Tsujinaka Hospital
  • Tokyo Medical and Dental University Hospital
  • Hitachi General Hospital
  • Asahikawa Medical University Hospital
  • Ofuna Chuo Hospital
  • Kishiwada Tokushukai Hospital
  • Kumamoto University Hospital
  • Japanese Red Cross Kumamoto Hospital
  • Kyorin University Hospital
  • Sendai Kosei Hospital
  • Kenseikai Dongo Hospital
  • The Hospital of Hyogo College of Medicine
  • Ishida Clinic of IBD and Gastroenterology
  • Okayama University Hospital
  • Kitasato University Hospital
  • Saga University Hospital
  • Saitama Medical Center
  • Sapporo Tokushukai Hospital
  • Jichi Medical University Hospital
  • Tokyo Women's Medical University Hospital
  • Tokyo Metropolitan Bokutoh Hospital
  • Osaka Medical and Pharmaceutical University Hospital
  • National Center for Global Health and Medicine
  • Toyama Prefectural Central Hospital
  • NHO Toyohashi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guselkumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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. .
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.
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.
Serum Concentation of Guselkumab
Serum concentration of Guselkumab will be reported.
Number of Participants with Anti-Guselkumab Antibodies
Number of participants with anti-Guselkumab antibodies will be reported.
Change from Baseline in C-reactive protein (CRP)
Change from baseline in C-reactive protein (CRP) will be reported.
Change from Baseline in Fecal Calprotectin (FC) Levels
Change from baseline in Fecal Calprotectin (FC) Levels will be reported.

Full Information

First Posted
May 18, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT04397263
Brief Title
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohns Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guselkumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
CNTO1959
Intervention Description
Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to Week 48
Secondary Outcome Measure Information:
Title
Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score
Description
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. .
Time Frame
Baseline to Week 48
Title
Change from Baseline in Patient-Reported Outcome (PRO)-2 Score
Description
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.
Time Frame
Baseline to Week 48
Title
Change from Baseline in Simplified Endoscopic Score for Crohn's disease (SES-CD) Score
Description
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.
Time Frame
Baseline and Week 48
Title
Serum Concentation of Guselkumab
Description
Serum concentration of Guselkumab will be reported.
Time Frame
Up to Week 48
Title
Number of Participants with Anti-Guselkumab Antibodies
Description
Number of participants with anti-Guselkumab antibodies will be reported.
Time Frame
Up to Week 48
Title
Change from Baseline in C-reactive protein (CRP)
Description
Change from baseline in C-reactive protein (CRP) will be reported.
Time Frame
Baseline and Week 4, 8, 12, 16, 20, 24, 32, 40 and 48
Title
Change from Baseline in Fecal Calprotectin (FC) Levels
Description
Change from baseline in Fecal Calprotectin (FC) Levels will be reported.
Time Frame
Baseline and Week 4, 8, 12, 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
Facility Name
KOKIKAI Tokatsu Tsujinaka Hospital
City
Abiko
ZIP/Postal Code
270-1168
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Hitachi General Hospital
City
Hitachi
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Asahikawa Medical University Hospital
City
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Ofuna Chuo Hospital
City
Kamakura
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
ZIP/Postal Code
5960042
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Sendai Kosei Hospital
City
Miyagi
ZIP/Postal Code
9800873
Country
Japan
Facility Name
Kenseikai Dongo Hospital
City
Nara
ZIP/Postal Code
635-0022
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Ishida Clinic of IBD and Gastroenterology
City
Oita
ZIP/Postal Code
8700823
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-shi
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Saitama Medical Center
City
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Sapporo Tokushukai Hospital
City
Sapporo
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Tokyo Metropolitan Bokutoh Hospital
City
Sumida-ku
ZIP/Postal Code
130-8575
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
9308550
Country
Japan
Facility Name
NHO Toyohashi Medical Center
City
Toyohashi
ZIP/Postal Code
441-8570
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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