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A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (DUET-UC)

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ClinicalTrials.gov Identifier: NCT05242484
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE February 15, 2022
First Posted Date  ICMJE February 16, 2022
Last Update Posted Date April 24, 2024
Actual Study Start Date  ICMJE September 19, 2022
Estimated Primary Completion Date May 27, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2022)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2022)
  • 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.
  • 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.
  • 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.
  • Percentage of Participants with Clinical Remission at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission based on the modified Mayo subscores
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants with Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
    Percentage of participants with antibodies to guselkumab will be reported.
  • Titers of Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
    Titers of antibodies to guselkumab will be reported.
  • Percentage of Participants with Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
    Percentage of Participants with Antibodies to golimumab will be reported.
  • Titers of Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
    Titers of antibodies to golimumab will be reported.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants with Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
    Percentage of participants with antibodies to guselkumab will be reported.
  • Titers of Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
    Titers of antibodies to guselkumab will be reported.
  • Percentage of Participants with Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
    Percentage of Participants with Antibodies to golimumab will be reported.
  • Titers of Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
    Titers of antibodies to golimumab will be reported.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Biological: Guselkumab
    Guselkumab will be administered as subcutaneous injection.
  • Biological: Golimumab
    Golimumab will be administered as subcutaneous injection.
  • Biological: JNJ-78934804
    JNJ-78934804 will be administered subcutaneously as per defined regimen.
  • Drug: Placebo
    Placebo will be administered as subcutaneous injection.
Study Arms  ICMJE
  • Placebo Comparator: Group 1: Placebo
    Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
    Intervention: Drug: Placebo
  • Experimental: Group 2: Guselkumab
    Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
    Intervention: Biological: Guselkumab
  • Experimental: Group 3: Golimumab
    Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
    Intervention: Biological: Golimumab
  • Experimental: Group 4: JNJ-78934804 (High-dose)
    Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
    Intervention: Biological: JNJ-78934804
  • Experimental: Group 5: JNJ-78934804 (Mid-dose)
    Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
    Intervention: Biological: JNJ-78934804
  • Experimental: Group 6: JNJ-78934804 (Low-dose)
    Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
    Intervention: Biological: JNJ-78934804
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2022)		 550
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2022)		 500
Estimated Study Completion Date  ICMJE October 10, 2029
Estimated Primary Completion Date May 27, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Croatia,   Czechia,   Denmark,   Estonia,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Jordan,   Korea, Republic of,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Lithuania,   Mexico,   Serbia,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT05242484
Other Study ID Numbers  ICMJE CR109179
78934804UCO2001 ( Other Identifier: Janssen Research & Development, LLC )
2021-005528-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Current Responsible Party Janssen Research & Development, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Janssen Research & Development, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP