A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Guselkumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a documented diagnosis of Crohn's disease (CD) confirmed by endoscopic, histologic, and/or radiologic studies prior to resection or by tissue obtained at resection Have undergone an ileocolonic surgical resection (that is, an intestinal resection with an ileocolonic anastomosis) for CD prior to the baseline visit with the following criteria: (a)Have no known active CD anywhere in the gastrointestinal (GI) tract, including the findings at surgery. (b)Be able to undergo randomization no later than 49 days after surgery, and at least 10 days after surgery (or 8 days after resumption of bowel activity, example, in case of postoperative ileus) (c) Ileocolonic resection was not for the purpose of removing known dysplasia. (d) If ileocolonic resection is the participant's first resection for Crohn's, and occurs greater than (>) 10 years since the diagnosis of CD and only fibrostenotic stricturing is present, then length of stricture must be > 10 centimeter (cm) Have a baseline Crohn's Disease Activity Index (CDAI) less than (<) 200 A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) test result during screening and a negative urine pregnancy test at week 0, prior to randomization A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 12 weeks after the last administration of study intervention Exclusion Criteria: Has complications of CD, such as symptomatic strictures or stenoses, short bowel syndrome, a draining (that is, functioning) stoma or ostomy, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery Have had any active perianal disease within 3 months of screening (except skin tags) or have had any draining fistula within 3 months of screening unless the fistula was removed at the index surgery Evidence of a herpes zoster infection within 8 weeks before the first dose of study intervention Has a history of severe, progressive, or uncontrolled renal, genitourinary, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Guselkumab<br>Participants will receive Guselkumab Dose 1 subcutaneously (SC) followed by Dose 2 SC thereafter through Week 144. Participants with disease recurrence will receive guselkumab SC treatment. | Drug: Guselkumab<br>* Guselkumab will be administered subcutaneously.<br>* Other names: CNTO1959;|
| Placebo Comparator: Group 2: Placebo<br>Participants will receive matching placebo injections subcutaneously. Participants with disease recurrence will receive guselkumab SC treatment. | Drug: Placebo<br>* Placebo will be administered subcutaneously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Endoscopic Recurrence Prior to or at Week 48 | Endoscopic recurrence is defined by modified Rutgeerts score greater than or equal to (>=) i2a in the neo-terminal ileum, anastomotic site, or its equivalent elsewhere in the gastrointestinal (GI) tract. | Up to Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission Without Disease Recurrence at Week 48 | Clinical remission without disease recurrence is defined by the following: Crohn's Disease Activity Index (CDAI) less than (<)150 at Week 48 and No endoscopic recurrence. Have not experienced a disease recurrence. The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity. | At Week 48 | 
| Time-to-Disease Recurrence | Disease recurrence is defined as one of the following: (1) >= 70-point increase from baseline in CDAI score at beyond 8 weeks after randomization; and a CDAI score of >= 200 and evidence of endoscopic recurrence; (2) Initiation of a physician-prescribed corticosteroids, or an increase in the dose of steroids already being taken (by greater than 5 milligrams per day [mg/day]), for over one week for the treatment of Crohn's disease (CD) and evidence of endoscopic recurrence as described above; (3) A new draining external fistula; (4) The reopening and draining of a previously existing external fistula; (5) Developing a new internal fistula; (6) Developing a new perianal abscess; (7) Or developing a new intra abdominal abscess more than three months after the date of the index surgery. | Up to Week 48 | 
| Number of Participants with No Abdominal Pain At Week 48 | Number of patients with an abdominal pain score of 0 at Week 48 will be reported. | At Week 48 | 
| Time To Recurrence of Symptoms | Time to recurrence of symptoms, defined as time to attaining an abdominal pain mean daily score greater than (>) 1 (and also >1 point higher than baseline) along with stool frequency (SF) mean daily score >3 (and also >3 higher per day than baseline) for 2 consecutive weeks through Week 48. | Up to Week 48 | 
| Number of Participants with Adverse Events (AEs) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | 156 Weeks | 
| Number of Participants with Serious Adverse Events (SAEs) | 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. | 156 weeks | 
| Serum Guselkumab Concentrations Over Time | Serum guselkumab concentrations over time will be assessed. | At Week 0, 8, 16, 24, 32, 48, 96, 128, and 152 | 
| Steroid Free Clinical Remission at Week 48 | Steroid free clinical remission at Week 48, defined as CDAI < 150 and no corticosteroids within 30 days. The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity. | At Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, Postoperative, Ileocolonic resection