A Study of Guselkumab Subcutaneous Therapy 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 efficacy and safety of guselkumab in participants with Crohn's disease.

Detailed Description
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Crohn's disease is a chronic, progressive and potentially life-threatening disorder which may affect any part of the gastrointestinal (GI) tract. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to human interleukin (IL)-23, thereby blocking the binding of extracellular IL-23 to the cell surface IL-23 receptor. This binding results in inhibition of IL-23 mediated intracellular signaling, activation and cytokine production. The purpose of the study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease. The overall study duration is up to 109 weeks.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: Guselkumab Dose 1
* Drug: Guselkumab Dose 2
* Drug: Guselkumab Dose 3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Crohn's disease (CD) of at least 3 months in duration Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD). Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: Current diagnosis of ulcerative colitis or indeterminate colitis Complications of Crohn's disease that require surgical intervention or confound efficacy assessments Unstable doses of concomitant Crohn's disease therapy

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Guselkumab<br>Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously. | Drug: Guselkumab Dose 1<br>* Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.<br>Drug: Guselkumab Dose 2<br>* Guselkumab (Dose 2) will be administered by SC injection.<br>|
| Experimental: Group 2: Guselkumab<br>Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously. | Drug: Guselkumab Dose 1<br>* Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.<br>Drug: Guselkumab Dose 3<br>* Guselkumab (Dose 3) will be administered by SC injection.<br>|
| Placebo Comparator: Group 3: Placebo<br>Participants will receive placebo injection subcutaneously. | Drug: Placebo<br>* Placebo will be administered by SC injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission at Week 12 | Clinical Remission is based on Crohn's Disease Activity Index (CDAI). | Week 12 | 
| Endoscopic Response at Week 12 | Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission at Week 24 | Clinical Remission is based in CDAI. | Week 24 | 
| Patient-reported Outcome (PRO)-2 Remission at Week 12 | PRO-2 remission is based on abdominal pain (AP) and stool frequency (SF) score. | Week 12 | 
| Clinical Response at Week 12 | Clinical response is based on change from baseline in CDAI. | Week 12 | 
| Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention | Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 109 Weeks |