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ACTIVE NOT RECRUITING Phase 2

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

NCT05242484 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

Conditions Studied

Interventions

  • DRUG Placebo
  • BIOLOGICAL Guselkumab
  • BIOLOGICAL Golimumab
  • BIOLOGICAL JNJ-78934804

Study Locations (20)

Florida

  • Pioneer Research Solutions Inc. — Coconut Creek
  • Digestive and Liver Disease Institute — Kissimmee
  • Osceola Regional Hospital — Kissimmee
  • Florida Research Center Inc. — Lakewood Rch
  • University of Miami — Miami
  • Gastroenterology Group Of Naples — Naples
  • Omega Research Consultants — Orlando
  • Synergy Clinical Research — St. Petersburg
  • GCP Clinical Research — Tampa

California

  • Valley Gastroenterology Medical Group — Arcadia
  • Southern California Research Center — Coronado
  • Om Research LLC — Lancaster
  • Cedars Sinai Medical Center — Los Angeles
  • University of California San Francisco — San Francisco

Colorado

  • University of Colorado — Aurora
  • Peak Gastroenterology Associates — Colorado Springs

Connecticut

  • Medical Research Center of Connecticut — Hamden
  • Yale University — New Haven

District of Columbia

  • MedStar Georgetown University Hospital — Washington D.C.

Georgia

  • Atlanta Gastroenterology Associates — Atlanta

Trial Details

FieldValue
Enrollment Target 577 participants
Start Date 2022-09-19
Est. Completion 2029-03-27
Phase Phase 2

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05242484

The ClinicalTrials.gov registry entry for NCT05242484 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 577 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: NCT05242484 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Colorado. 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 NCT05242484 about?

NCT05242484 is a clinical study titled "A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advance...

What is the current status of trial NCT05242484?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 577 participants. The study started on 2022-09-19. Estimated completion is 2029-03-27.

What conditions does trial NCT05242484 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 NCT05242484?

The interventions under investigation include: Placebo (DRUG), Guselkumab (BIOLOGICAL), Golimumab (BIOLOGICAL), JNJ-78934804 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05242484?

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 NCT05242484 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. 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