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

NCT05784129 | Terminated Phase 3 Results FDA Drug

• 3 other identifiers: CR1092922022-002389-33CNTO1959CRD3007
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 11

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

Keywords

Endoscopy, Postoperative, Ileocolonic resection

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Endoscopic Recurrence Prior to or at Week 48

  Endoscopic recurrence was defined by modified Rutgeerts score greater than or equal to (\>=) i2a in neo-terminal ileum, anastomotic site, or its equivalent in gastrointestinal (GI) tract (e.g., colonic ulceration). The modified Rutgeerts score ranged from i0 to i4, where i0 (No lesions), i1 (less than \[\<\] 5 aphthous lesions), i2 (greater than \[\>\] 5 aphthous lesions with normal mucosa between lesions or skip areas of larger lesions or lesions confined to ileocolonic anastomosis \[\<1 centimeter (cm) in length\]), i2a (lesions confined to ileocolonic anastomosis \[including anastomotic stenosis\]), i2b (more than 5 aphthous ulcers or larger lesions, with normal mucosa in-between, in the neoterminal ileum \[with or without anastomotic lesions\]), i3 (diffuse aphthous ileitis with diffusely inflamed mucosa), i4 (large ulcers with diffuse mucosal inflammation or nodules or stenosis in neoterminal ileum). Higher score indicated worsening.

  Baseline (Day 1) up to Week 48

Secondary Outcomes (7)

• Percentage of Participants With Clinical Remission Without Disease Recurrence at Week 48

  At Week 48

• Time to Disease Recurrence

  Baseline (Day 1) up to Week 48

• Percentage of Participants With No Abdominal Pain at Week 48

  At Week 48

• Time To Recurrence of Symptoms

  Baseline (Day 1) up to Week 48

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

  Baseline (Day 1) up to early termination of trial (up to Week 28)

Study Arms (2)

Group 1: Guselkumab

ACTIVE COMPARATOR

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

Group 2: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Guselkumab DRUG

Guselkumab will be administered subcutaneously.

Also known as: CNTO1959

Group 1: Guselkumab

Placebo DRUG

Placebo will be administered subcutaneously.

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (11)

Medical Associates Research Group, Inc.

San Diego, California, 92123, United States

Location

Gastroenterology Group Of Naples

Naples, Florida, 34102, United States

Location

Gastroenterolgy Associates of Central GA

Macon, Georgia, 31201, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Asheville Gastroenterology Associates

Asheville, North Carolina, 28801, United States

Location

Gastro Health Ohio

Cincinnati, Ohio, 45219, United States

Location

Southern Star Research Institute, LLC

San Antonio, Texas, 78229, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

Centrum Medyczne Medyk

Rzeszów, 35-326, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

Due to early termination of study, protocol planned primary endpoint and few of secondary endpoints were not evaluable. Termination was not related to safety or efficacy of guselkumab.

Results Point of Contact

• Title: Medical Director Gastroenterology
• Organization: Janssen Pharmaceuticals, Inc, US Medical Affairs

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: February 21, 2023
• Primary Completion: September 29, 2023
• Study Completion: October 10, 2023
• Last Updated: April 29, 2025
• Results First Posted: October 28, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (9); PL (2)