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

NCT ID: NCT05784129

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2023-10-10

Brief Summary

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Guselkumab

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.

Group Type: ACTIVE_COMPARATOR

Guselkumab

Intervention Type: DRUG

Guselkumab will be administered subcutaneously.

Group 2: Placebo

Participants will receive matching placebo injections subcutaneously. Participants with disease recurrence will receive guselkumab SC treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously.

Interventions

Guselkumab

Guselkumab will be administered subcutaneously.

Intervention Type: DRUG

Placebo

Placebo will be administered subcutaneously.

Intervention Type: DRUG

Other Intervention Names

CNTO1959

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Medical Associates Research Group, Inc.

San Diego, California, United States

Gastroenterology Group Of Naples

Naples, Florida, United States

Gastroenterolgy Associates of Central GA

Macon, Georgia, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Asheville Gastroenterology Associates

Asheville, North Carolina, United States

Gastro Health Ohio

Cincinnati, Ohio, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

Texas Digestive Disease Consultants

Southlake, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

Centrum Medyczne Medyk

Rzeszów, , Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Countries

United States; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-002389-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO1959CRD3007

Identifier Type: OTHER

Identifier Source: secondary_id

CR109292

Identifier Type: -

Identifier Source: org_study_id