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ACTIVE NOT RECRUITING Phase 3

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

NCT05528510 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Guselkumab Dose 1
  • DRUG Guselkumab Dose 2
  • DRUG Guselkumab Dose 3

Study Locations (20)

Florida

  • Gastro Florida — Clearwater
  • I.H.S. Health. LLC — Kissimmee
  • Columbus Clinical Services LLC — Miami
  • Vista Health Research, LLC — Miami
  • Orlando Health — Orlando
  • Theia Clincial Research, LLC — Temple Terrace

California

  • Om Research LLC — Apple Valley
  • Om Research LLC — Lancaster
  • Medical Associates Research Group, Inc. — San Diego

Georgia

  • Digestive Healthcare of Georgia, P.C — Atlanta
  • Atlanta Gastroenterology Associates — Atlanta
  • Gastroenterology Associates of Central GA — Macon

Michigan

  • Clinical Research Institute of Michigan, LLC — Chesterfield
  • Detroit Clinical Research Center — Farmington Hills

North Carolina

  • University of North Carolina — Chapel Hill
  • Peters Medical Research — High Point

Arizona

  • Research Solutions of Arizona — Litchfield Park

Colorado

  • Peak Gastroenterology Associates — Colorado Springs

Kansas

  • Cotton O'Neil Digestive Health Center — Topeka

Trial Details

FieldValue
Enrollment Target 418 participants
Start Date 2022-09-13
Est. Completion 2028-10-06
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05528510

The ClinicalTrials.gov registry entry for NCT05528510 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 418 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05528510 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05528510 about?

NCT05528510 is a clinical study titled "A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

What is the current status of trial NCT05528510?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 418 participants. The study started on 2022-09-13. Estimated completion is 2028-10-06.

What conditions does trial NCT05528510 study?

This clinical trial studies the following conditions: Colitis, Ulcerative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05528510?

The interventions under investigation include: Placebo (OTHER), Guselkumab Dose 1 (DRUG), Guselkumab Dose 2 (DRUG), Guselkumab Dose 3 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05528510?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05528510 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial