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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Poland, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Arms & Interventions


Active Comparator: 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.

Placebo Comparator: Group 2: Placebo

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


Drug: - Guselkumab

Guselkumab will be administered subcutaneously.

Drug: - Placebo

Placebo will be administered subcutaneously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Medical Associates Research Group, Inc., San Diego, California




Medical Associates Research Group, Inc.

San Diego, California, 92123

Gastroenterology Group Of Naples, Naples, Florida




Gastroenterology Group Of Naples

Naples, Florida, 34102

Gastroenterolgy Associates of Central GA, Macon, Georgia




Gastroenterolgy Associates of Central GA

Macon, Georgia, 31201

Asheville Gastroenterology Associates, Asheville, North Carolina




Asheville Gastroenterology Associates

Asheville, North Carolina, 28801

Cincinnati, Ohio




Greater Cincinnati Gastroenterology Association, Inc.

Cincinnati, Ohio, 45219

Gastroenterology Research of San Antonio, San Antonio, Texas




Gastroenterology Research of San Antonio

San Antonio, Texas, 78212

Texas Digestive Disease Consultants, Southlake, Texas




Texas Digestive Disease Consultants

Southlake, Texas, 76092

Tyler Research Institute, LLC, Tyler, Texas




Tyler Research Institute, LLC

Tyler, Texas, 75701

International Sites

Centrum Medyczne Medyk, Rzeszow, Poland




Centrum Medyczne Medyk

Rzeszow, , 35-326