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

Primary Purpose

Crohn's Disease

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Endoscopy, Postoperative, Ileocolonic resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Associates Research Group, Inc.
  • Gastroenterology Group Of Naples
  • Gastroenterolgy Associates of Central GA
  • Louisiana Research Center, LLC
  • Asheville Gastroenterology Associates
  • Greater Cincinnati Gastroenterology Association, Inc.
  • Gastroenterology Research of San Antonio
  • Texas Digestive Disease Consultants
  • Tyler Research Institute, LLC
  • Centrum Medyczne Medyk
  • WIP Warsaw IBD Point Profesor Kierkus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1: Guselkumab

Group 2: Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Serum Guselkumab Concentrations Over Time
Serum guselkumab concentrations over time will be assessed.
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.

Full Information

First Posted
March 13, 2023
Last Updated
October 9, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05784129
Brief Title
A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
September 29, 2023 (Actual)
Study Completion Date
December 29, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Endoscopy, Postoperative, Ileocolonic resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Guselkumab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo injections subcutaneously. Participants with disease recurrence will receive guselkumab SC treatment.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
CNTO1959
Intervention Description
Guselkumab will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered subcutaneously.
Primary Outcome Measure Information:
Title
Percentage of Participants with Endoscopic Recurrence Prior to or at Week 48
Description
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.
Time Frame
Up to Week 48
Secondary Outcome Measure Information:
Title
Clinical Remission Without Disease Recurrence at Week 48
Description
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.
Time Frame
At Week 48
Title
Time-to-Disease Recurrence
Description
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.
Time Frame
Up to Week 48
Title
Number of Participants with No Abdominal Pain At Week 48
Description
Number of patients with an abdominal pain score of 0 at Week 48 will be reported.
Time Frame
At Week 48
Title
Time To Recurrence of Symptoms
Description
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.
Time Frame
Up to Week 48
Title
Number of Participants with Adverse Events (AEs)
Description
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.
Time Frame
156 Weeks
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
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.
Time Frame
156 weeks
Title
Serum Guselkumab Concentrations Over Time
Description
Serum guselkumab concentrations over time will be assessed.
Time Frame
At Week 0, 8, 16, 24, 32, 48, 96, 128, and 152
Title
Steroid Free Clinical Remission at Week 48
Description
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.
Time Frame
At Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Gastroenterology Group Of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Gastroenterolgy Associates of Central GA
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Greater Cincinnati Gastroenterology Association, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Gastroenterology Research of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-326
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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