Clinical trial NCT05784129: A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Endoscopy, Postoperative, Ileocolonic resection
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Endoscopic Recurrence Prior to or at Week 48
timeFrame: Baseline (Day 1) up to Week 48
Secondary outcomes:
measure: Percentage of Participants With Clinical Remission Without Disease Recurrence at Week 48
timeFrame: At Week 48
measure: Time to Disease Recurrence
timeFrame: Baseline (Day 1) up to Week 48
measure: Percentage of Participants With No Abdominal Pain at Week 48
timeFrame: At Week 48
measure: Time To Recurrence of Symptoms
timeFrame: Baseline (Day 1) up to Week 48
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline (Day 1) up to early termination of trial (up to Week 28)
measure: Serum Guselkumab Concentrations Over Time
timeFrame: At Weeks 0, 8, 16
measure: Percentage of Participants With Steroid Free Clinical Remission at Week 48
timeFrame: At Week 48
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: Naples
country: United States
facility: Gastroenterology Group Of Naples
state: Florida
city: Macon
country: United States
facility: Gastroenterolgy Associates of Central GA
state: Georgia
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Gastro Health Ohio
state: Ohio
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: