History of Changes for Study: NCT05242484

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

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Study Record Versions

Version	Submitted Date	Changes
1	February 15, 2022	None (earliest Version on record)
2	March 24, 2022	Study Status
3	May 13, 2022	Arms and Interventions, Contacts/Locations, Study Status, Eligibility, Outcome Measures, Study Design and Study Identification
4	June 16, 2022	Study Status and Contacts/Locations
5	July 14, 2022	Contacts/Locations, Study Status and Oversight
6	October 6, 2022	Recruitment Status, Contacts/Locations, Study Status and Oversight
7	November 3, 2022	Contacts/Locations and Study Status
8	December 1, 2022	Contacts/Locations and Study Status
9	December 20, 2022	Contacts/Locations and Study Status
10	January 17, 2023	Study Status and Contacts/Locations
11	February 14, 2023	Contacts/Locations and Study Status
12	March 14, 2023	Contacts/Locations and Study Status
13	April 11, 2023	Contacts/Locations and Study Status
14	May 2, 2023	Contacts/Locations and Study Status
15	May 30, 2023	Contacts/Locations and Study Status
16	June 28, 2023	Study Status and Contacts/Locations
17	July 19, 2023	Study Status and Contacts/Locations
18	August 15, 2023	Contacts/Locations and Study Status
19	September 12, 2023	Contacts/Locations and Study Status
20	October 10, 2023	Contacts/Locations and Study Status
21	November 7, 2023	Contacts/Locations and Study Status
22	December 5, 2023	Contacts/Locations and Study Status
23	January 2, 2024	Contacts/Locations and Study Status
24	January 30, 2024	Contacts/Locations and Study Status
25	February 27, 2024	Study Status and Contacts/Locations
26	March 26, 2024	Contacts/Locations and Study Status
27	April 23, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CR109179
Brief Title:	A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (DUET-UC)
Official Title:	A Phase 2b Randomized, Double-blind, Active-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
Secondary IDs:	78934804UCO2001 [Janssen Research & Development, LLC] 2021-005528-39 [EudraCT Number]

Study Status


Record Verification:	February 2022
Overall Status:	Not yet recruiting
Study Start:	May 20, 2022
Primary Completion:	August 28, 2024 [Anticipated]
Study Completion:	October 23, 2024 [Anticipated]

First Submitted:	February 15, 2022
First Submitted that Met QC Criteria:	February 15, 2022
First Posted:	February 16, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	February 15, 2022
Last Update Posted:	February 16, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Janssen Research & Development, LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


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:

Conditions


Conditions:	Colitis, Ulcerative
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	5
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	500 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Group 1: Guselkumab Participants will receive guselkumab dose regimen 1 subcutaneously (SC). Participants who are eligible and willing to continue their study treatment may enter the long-term study extension and continue to receive guselkumab SC.	Biological: Guselkumab Guselkumab will be administered as subcutaneous injection.
Experimental: Group 2: Golimumab Participants will receive golimumab dose regimen 1 SC. Participants who are eligible and willing to continue their study treatment may enter the long-term study extension and continue to receive golimumab SC.	Biological: Golimumab Golimumab will be administered as subcutaneous injection.
Experimental: Group 3: JNJ-78934804 (High-dose) Participants will receive JNJ-78934804 dose regimen 1 SC. Participants who are eligible and willing to continue their study treatment may enter the long-term study extension and continue to receive JNJ-78934804 SC.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.
Experimental: Group 4: JNJ-78934804 (Mid-dose) Participants will receive JNJ-78934804 dose regimen 2 SC. Participants who are eligible and willing to continue their study treatment may enter the long-term study extension and continue to receive JNJ-78934804 SC.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.
Experimental: Group 5: JNJ-78934804 (Low-dose) Participants will receive JNJ-78934804 dose regimen 3 SC. Participants who are eligible and willing to continue their study treatment may enter the long-term study extension and continue to receive JNJ-78934804 SC.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.

Outcome Measures


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 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.
5.	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.
6.	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.
7.	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.
8.	Percentage of Participants with Antibodies to Guselkumab [ Time Frame: Up to Week 48 ] Percentage of participants with antibodies to guselkumab will be reported.
9.	Titers of Antibodies to Guselkumab [ Time Frame: Up to Week 48 ] Titers of antibodies to guselkumab will be reported.
10.	Percentage of Participants with Antibodies to Golimumab [ Time Frame: Up to Week 48 ] Percentage of Participants with Antibodies to golimumab will be reported.
11.	Titers of Antibodies to Golimumab [ Time Frame: Up to Week 48 ] Titers of antibodies to golimumab will be reported.
12.	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.
13.	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


Minimum Age:	18 Years
Maximum Age:	65 Years
Sex:	All
Gender Based:
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 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/Locations


Central Contact Person:	Study Contact Telephone: 844-434-4210 Email: JNJ.CT@sylogent.com
Study Officials:	Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Locations:	United States, Florida
	Omega Research Consultants Orlando, Florida, United States, 32808

IPDSharing


Plan to Share IPD:	Yes 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
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: https://www.janssen.com/clinical-trials/transparency

References


Citations:
Links:
Available IPD/Information: