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

Crohn's Disease Clinical Trial

— PROGRESS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05784129
• Other study ID #: CR109292
• Secondary ID: 2022-002389-33CN
• Status: Terminated
• Phase: Phase 3
• Start date: February 21, 2023
• Est. completion date: October 10, 2023

Study information

• Verified date: November 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 10, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Guselkumab
Guselkumab will be administered subcutaneously.
• Placebo
Placebo will be administered subcutaneously.

Locations

Country	Name	City	State
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Greater Cincinnati Gastroenterology Association, Inc.	Cincinnati	Ohio
United States	Gastroenterolgy Associates of Central GA	Macon	Georgia
United States	Gastroenterology Group Of Naples	Naples	Florida
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	Medical Associates Research Group, Inc.	San Diego	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Texas Digestive Disease Consultants	Southlake	Texas
United States	Tyler Research Institute, LLC	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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