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NCT Number: NCT05242484

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 advanced therapy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CIPREC, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
  • Moderately to severely active UC as assessed by the modified Mayo score
  • Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
  • If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion criteria

  • Has severe extensive colitis as defined in the protocol
  • Extent of inflammatory disease limited to the rectum
  • Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
  • Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
  • Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Treatment and study plan

Guselkumab

Biological

Guselkumab will be administered as subcutaneous injection.

Golimumab

Biological

Golimumab will be administered as subcutaneous injection.

JNJ-78934804

Biological

JNJ-78934804 will be administered subcutaneously as per defined regimen.

Placebo

Drug

Placebo will be administered as subcutaneous injection.

Primary outcomes

  1. Percentage of Participants with Clinical Remission at Week 48

    Time frame: Week 48

    Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.

Secondary outcomes

  1. Percentage of Participants with Endoscopic Improvement at Week 48

    Time frame: Week 48

    Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.

  2. Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48

    Time frame: Week 48

    Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.

  3. Percentage of Participants with Symptomatic Remission at Week 48

    Time frame: Week 48

    Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.

  4. Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48

    Time frame: Week 48

    Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.

  5. Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48

    Time frame: Week 48

    Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores will be reported.

  6. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to Week 48

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

  7. Percentage of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to Week 48

    A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

  8. Laboratory Parameters Over Time

    Time frame: Up to Week 48

    Laboratory parameters over time will be reported.

  9. Vital Signs Parameters Over Time

    Time frame: Up to Week 48

    Vital signs parameters over time will be reported.

  10. Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: Up to Week 48

    The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.

  11. Serum Concentrations of Guselkumab Over Time

    Time frame: Up to Week 48

    Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.

  12. Serum Concentrations of Golimumab Over Time

    Time frame: Up to Week 48

    Serum concentration of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.

  13. Percentage of Participants with Antibodies to Guselkumab

    Time frame: Up to Week 48

    Percentage of participants with antibodies to guselkumab will be reported.

  14. Titers of Antibodies to Guselkumab

    Time frame: Up to Week 48

    Titers of antibodies to guselkumab will be reported.

  15. Percentage of Participants with Antibodies to Golimumab

    Time frame: Up to Week 48

    Percentage of Participants with Antibodies to golimumab will be reported.

  16. Titers of Antibodies to Golimumab

    Time frame: Up to Week 48

    Titers of antibodies to golimumab will be reported.

  17. Percentage of Participants with Neutralizing Antibodies to Guselkumab

    Time frame: Up to Week 48

    Percentage of participants with neutralizing antibodies to guselkumab will be reported.

  18. Percentage of Participants with Neutralizing Antibodies to Golimumab

    Time frame: Up to Week 48

    Percentage of participants with neutralizing antibodies to golimumab will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Acronym: DUET-UC

Important dates

Study start
2022
Primary completion
2025
Study completion
2029
First posted
Feb 16, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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