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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 tests if a drug can reduce the chance of Crohn's returning after surgery.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 0, 8, 16, 24, 32, 48, 96, 128, and 152
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 0, 8, 16, 24, 32, 48, 96, 128, and 152 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Endoscopic Recurrence Prior to or at Week 48
Secondary outcome measures
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 more

Trial 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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,289 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,943 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05784129 — Phase 3
Crohn's Disease Research Study Groups: Group 2: Placebo, Group 1: Guselkumab
Crohn's Disease Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT05784129 — Phase 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05784129 — Phase 3
Crohn's Disease Patient Testimony for trial: Trial Name: NCT05784129 — Phase 3
~2 spots leftby Jul 2025