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

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

Official Title
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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

Conditions
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Crohns Disease

Intervention / Treatment
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* Drug: Guselkumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guselkumab<br>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<br>* Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.<br>* Other names: CNTO1959;|

What is the study measuring?
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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 |