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

NCT05242484
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
577
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2022-09-19
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Number of sites
403
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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.
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Acronym
DUET-UC
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Short title
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
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Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2029-03-27
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First posted
2022-02-16
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Registry last updated
2026-08-28
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Primary completion date
2025-05-15
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Start date
2022-09-19
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Actual participants
577
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Participants
577
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
403
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05242484
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ClinicalTrials.gov ID
NCT05242484
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants with Clinical Remission at Week 48

    Timeframe: Week 48

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

  1. Percentage of Participants with Endoscopic Improvement at Week 48

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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

    Timeframe: Up to Week 48

    Laboratory parameters over time will be reported.

  9. Vital Signs Parameters Over Time

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Up to Week 48

    Percentage of participants with antibodies to guselkumab will be reported.

  14. Titers of Antibodies to Guselkumab

    Timeframe: Up to Week 48

    Titers of antibodies to guselkumab will be reported.

  15. Percentage of Participants with Antibodies to Golimumab

    Timeframe: Up to Week 48

    Percentage of Participants with Antibodies to golimumab will be reported.

  16. Titers of Antibodies to Golimumab

    Timeframe: Up to Week 48

    Titers of antibodies to golimumab will be reported.

  17. Percentage of Participants with Neutralizing Antibodies to Guselkumab

    Timeframe: Up to Week 48

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

  18. Percentage of Participants with Neutralizing Antibodies to Golimumab

    Timeframe: Up to Week 48

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • 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

  • 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)
Sources for eligibility
clinicaltrials.gov

  • Valley Gastroenterology Medical GroupArcadia, United States
  • Southern California Research CenterCoronado, United States
  • Om Research LLCLancaster, United States
  • Cedars Sinai Medical CenterLos Angeles, United States
  • University of California San FranciscoSan Francisco, United States
  • University of ColoradoAurora, United States
  • Peak Gastroenterology AssociatesColorado Springs, United States
  • Medical Research Center of ConnecticutHamden, United States
  • Yale UniversityNew Haven, United States
  • MedStar Georgetown University HospitalWashington D.C., United States
  • Pioneer Research Solutions Inc.Coconut Creek, United States
  • Digestive and Liver Disease InstituteKissimmee, United States
  • Osceola Regional HospitalKissimmee, United States
  • Florida Research Center Inc.Lakewood Rch, United States
  • University of MiamiMiami, United States
  • Gastroenterology Group Of NaplesNaples, United States
  • Omega Research ConsultantsOrlando, United States
  • Synergy Clinical ResearchSt. Petersburg, United States
  • GCP Clinical ResearchTampa, United States
  • Atlanta Gastroenterology AssociatesAtlanta, United States
  • Gastroenterolgy Associates of Central GAMacon, United States
  • Atlanta Gastroenterology Associates 1Marietta, United States
  • Gastrointestinal Specialists of GeorgiaMarietta, United States
  • Gastroenterology ConsultantsRoswell, United States
  • Grand Teton GastroenterologyIdaho Falls, United States

And 378 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-504743-13-00
  • 2021-005528-39
  • 78934804UCO2001
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (3)