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

Phase 3

Active, not recruiting

• Conditions: Crohns Disease
• Interventions: Drug: Guselkumab

• Registration Number: NCT04397263
• Lead Sponsor: Janssen Pharmaceutical K.K.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-21
• Study Start: 2020-06-10
• Primary Completion: 2024-02-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Guselkumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Up to Week 48	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

Name	Time	Method
Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score	Baseline to Week 48	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	Baseline to Week 48	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 Fecal Calprotectin (FC) Levels	Baseline and Week 4, 8, 12, 24 and 48	Change from baseline in Fecal Calprotectin (FC) Levels will be reported.
Change from Baseline in Simplified Endoscopic Score for Crohn's disease (SES-CD) Score	Baseline and Week 48	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	Up to Week 48	Serum concentration of Guselkumab will be reported.
Change from Baseline in C-reactive protein (CRP)	Baseline and Week 4, 8, 12, 16, 20, 24, 32, 40 and 48	Change from baseline in C-reactive protein (CRP) will be reported.
Number of Participants with Anti-Guselkumab Antibodies	Up to Week 48	Number of participants with anti-Guselkumab antibodies will be reported.

Trial Locations

Locations (25)

Institute of Science Tokyo Hospital; 🇯🇵 Bunkyo ku, Japan

KOKIKAI Tokatsu Tsujinaka Hospital; 🇯🇵 Abiko, Japan

Hitachi General Hospital; 🇯🇵 Hitachi, Japan

Asahikawa Medical University Hospital; 🇯🇵 Hokkaido, Japan

Ofuna Chuo Hospital; 🇯🇵 Kamakura, Japan

Kishiwada Tokushukai Hospital; 🇯🇵 Kishiwada, Japan

Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan

Japanese Red Cross Kumamoto 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

Kitasato University Hospital; 🇯🇵 Sagamihara, Japan

Saga University Hospital; 🇯🇵 Saga, 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

Center Hospital of the National Center for Global Health and Medicine; 🇯🇵 Tokyo, Japan

Toyama Prefectural Central Hospital; 🇯🇵 Toyama, Japan

National Hospital Organization Toyohashi Medical Center; 🇯🇵 Toyohashi, Japan