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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 : Not yet recruiting
First Posted : February 16, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Biological: Guselkumab Biological: Golimumab Biological: JNJ-78934804 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 30, 2022
Estimated Primary Completion Date : August 28, 2024
Estimated Study Completion Date : October 23, 2024

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Placebo
Placebo will be administered as subcutaneous injection.
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.
 Biological: Guselkumab
Guselkumab will be administered as subcutaneous injection.
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.
 Biological: Golimumab
Golimumab will be administered as subcutaneous injection.
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.
 Biological: JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.
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.
 Biological: JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.
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.
 Biological: JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Percentage of Participants with Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
    Percentage of participants with antibodies to guselkumab will be reported.

  10. Titers of Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
    Titers of antibodies to guselkumab will be reported.

  11. Percentage of Participants with Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
    Percentage of Participants with Antibodies to golimumab will be reported.

  12. Titers of Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
    Titers of antibodies to golimumab will be reported.

  13. 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.

  14. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05242484


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05242484    
Other Study ID Numbers: CR109179
78934804UCO2001 ( Other Identifier: Janssen Research & Development, LLC )
2021-005528-39 ( EudraCT Number )
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Pathologic Processes
Inflammatory Bowel Diseases
Golimumab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs