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Monoclonal Antibodies
Guselkumab for Crohn's Disease (PROGRESS Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 0, 8, 16, 24, 32, 48, 96, 128, and 152
Awards & highlights
Summary
This trial is testing whether guselkumab can prevent Crohn's disease from coming back after surgery. It targets patients who have had surgery for Crohn's disease and works by reducing inflammation in the body.
Eligible Conditions
- Crohn's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 0, 8, 16, 24, 32, 48, 96, 128, and 152
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 0, 8, 16, 24, 32, 48, 96, 128, and 152
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants with Endoscopic Recurrence Prior to or at Week 48
Secondary study objectives
Clinical Remission Without Disease Recurrence at Week 48
Number of Participants with Adverse Events (AEs)
Number of Participants with No Abdominal Pain At Week 48
+5 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Group 1: GuselkumabActive Control1 Intervention
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.
Group II: Group 2: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo injections subcutaneously. Participants with disease recurrence will receive guselkumab SC treatment.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,655 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,961,455 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a CDAI score of less than 200.A woman of childbearing age must provide a negative serum beta-hCG test result during screening and a negative urine pregnancy test prior to randomization.You have had an ileocolonic surgical resection for Crohn's Disease, with no active CD anywhere in the gastrointestinal tract, at least 10 days after surgery (or 8 days after resumption of bowel activity) and not done to remove known dysplasiaFemale participants must abstain from donating eggs or freezing them for assisted reproduction purposes during the study and 12 weeks after their last intervention.You have a history of serious health issues affecting your kidneys, urinary system, blood, hormones, heart, blood vessels, lungs, joints, brain, mental health, or metabolism.You possess evidence of a Crohn's disease diagnosis obtained through endoscopic, histologic, radiologic, or resectional tissue studies.You have symptoms of Crohn's disease that may require surgery or make it difficult to evaluate your response to guselkumab treatment.You have had an active perianal disease or a draining fistula within the last 3 months, unless the fistula was removed during surgery. Skin tags are not considered a perianal disease.You have an abscess or are suspected to have one. If you had an abscess that was treated at least 3 weeks ago (for skin or anal abscess) or 8 weeks ago (for abdominal abscess) and you won't need any further surgery, you can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Placebo
- Group 2: Group 1: Guselkumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Crohn's Disease Patient Testimony for trial: Trial Name: NCT05784129 — Phase 3
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