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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05242484




Registration number
NCT05242484
Ethics application status
Date submitted
15/02/2022
Date registered
16/02/2022

Titles & IDs
Public title
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
78934804UCO2001
Secondary ID [2] 0 0
CR109179
Universal Trial Number (UTN)
Trial acronym
DUET-UC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Guselkumab
Treatment: Other - Golimumab
Treatment: Other - JNJ-78934804
Treatment: Drugs - Placebo

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.

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.

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.

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.

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.

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.


Treatment: Other: Guselkumab
Guselkumab will be administered as subcutaneous injection.

Treatment: Other: Golimumab
Golimumab will be administered as subcutaneous injection.

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

Treatment: Drugs: Placebo
Placebo will be administered as subcutaneous injection.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Clinical Remission at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants with Endoscopic Improvement at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Percentage of Participants with Symptomatic Remission at Week 48
Timepoint [3] 0 0
Week 48
Secondary outcome [4] 0 0
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
Timepoint [5] 0 0
Week 48
Secondary outcome [6] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [6] 0 0
Up to Week 48
Secondary outcome [7] 0 0
Percentage of Participants with Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Up to Week 48
Secondary outcome [8] 0 0
Laboratory Parameters Over Time
Timepoint [8] 0 0
Up to Week 48
Secondary outcome [9] 0 0
Vital Signs Parameters Over Time
Timepoint [9] 0 0
Up to Week 48
Secondary outcome [10] 0 0
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
Timepoint [10] 0 0
Up to Week 48
Secondary outcome [11] 0 0
Serum Concentrations of Guselkumab Over Time
Timepoint [11] 0 0
Up to Week 48
Secondary outcome [12] 0 0
Serum Concentrations of Golimumab Over Time
Timepoint [12] 0 0
Up to Week 48
Secondary outcome [13] 0 0
Percentage of Participants with Antibodies to Guselkumab
Timepoint [13] 0 0
Up to Week 48
Secondary outcome [14] 0 0
Titers of Antibodies to Guselkumab
Timepoint [14] 0 0
Up to Week 48
Secondary outcome [15] 0 0
Percentage of Participants with Antibodies to Golimumab
Timepoint [15] 0 0
Up to Week 48
Secondary outcome [16] 0 0
Titers of Antibodies to Golimumab
Timepoint [16] 0 0
Up to Week 48
Secondary outcome [17] 0 0
Percentage of Participants with Neutralizing Antibodies to Guselkumab
Timepoint [17] 0 0
Up to Week 48
Secondary outcome [18] 0 0
Percentage of Participants with Neutralizing Antibodies to Golimumab
Timepoint [18] 0 0
Up to Week 48

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/03/2029
Actual
Sample size
Target
Accrual to date
Final
577
Recruitment in Australia
Recruitment state(s)
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Box Hill Hospital - Box Hill
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Concord Hospital - Concord
Recruitment hospital [5] 0 0
Western Health - Footscray
Recruitment hospital [6] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - North Terrace
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [11] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
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2050 - Camperdown
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3168 - Clayton
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2139 - Concord
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3011 - Footscray
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4558 - Maroochydore
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6150 - Murdoch
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5000 - North Terrace
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
3004 - Prahran
Recruitment postcode(s) [11] 0 0
4101 - South Brisbane
Recruitment outside Australia
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Osaka
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Sakura
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Japan
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Japan
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Sapporo
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Japan
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Japan
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Japan
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Spain
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Spain
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Spain
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Spain
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Taoyuan
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05242484