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Monoclonal Antibodies

Combination Therapy for Ulcerative Colitis (DUET-UC Trial)

Phase 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

DUET-UC Trial Summary

This trial will compare the effectiveness of a new drug, JNJ-78934804, to existing treatments for ulcerative colitis.

Who is the study for?
This trial is for adults with moderate to severe ulcerative colitis who haven't responded well to at least one biologic or similar treatment. Participants must have been diagnosed with UC for a minimum of three months and, if female and able to have children, agree to follow specific contraception guidelines.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of JNJ-78934804 against guselkumab and golimumab in patients whose ulcerative colitis hasn't improved with standard advanced therapies. It aims to see which treatment helps more.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, injection site reactions, infections due to lowered immunity, allergic responses, and possibly others not yet known as these are newer treatments being studied.

DUET-UC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with ulcerative colitis for at least 3 months.
Select...
My ulcerative colitis is moderate to severe, according to the Mayo Score.

DUET-UC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Clinical Remission at Week 48
Secondary outcome measures
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Antibodies to Golimumab
Percentage of Participants with Antibodies to Guselkumab
+11 more

DUET-UC Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 6: JNJ-78934804 (Low-dose)Experimental Treatment1 Intervention
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.
Group II: Group 5: JNJ-78934804 (Mid-dose)Experimental Treatment1 Intervention
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.
Group III: Group 4: JNJ-78934804 (High-dose)Experimental Treatment1 Intervention
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.
Group IV: Group 3: GolimumabExperimental Treatment1 Intervention
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.
Group V: Group 2: GuselkumabExperimental Treatment1 Intervention
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.
Group VI: Group 1: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Golimumab
2014
Completed Phase 4
~3480

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,758 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,355 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis

Media Library

Golimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05242484 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current cap for enrollees in this clinical trial?

"Yes, according to clinicaltrials.gov this study is currently recruiting patients. It was first posted on September 19th 2022 and last updated on November 3rd 2022 with 79 different sites aiming to recruit 550 participants in total."

Answered by AI

Is enrollment still open for this research project?

"Data hosted on clinicaltrials.gov verifies that the recruitment process for this trial is ongoing, having been initiated on September 19th 2022 and most recently updated November 3rd of the same year."

Answered by AI

Are senior citizens being included in the clinical trial cohort?

"For those eligible to participate in this research, the age range is set between 18 and 65. Conversely, there are other trials that accept individuals younger than 18 years old (65 total) or over 65 (341 total)."

Answered by AI

To what degree can JNJ-78934804 be considered hazardous to patients?

"Given that JNJ-78934804 is in its second phase of trials, there are indications it could be safe for use; however, given the lack of evidence supporting efficacy, our team has assessed a score of 2."

Answered by AI

Is enrollment in this medical research still open?

"This medical trial is enrolling up to 550 patients between the ages of 18-65 who are suffering from ulcerative colitis. To be accepted, participants must have previously shown an inadequate response or intolerance towards a biologic drug or similar medication; if female, they should meet contraception and reproductive requirements; a confirmed diagnosis needs to have been present for at least three months prior to their enrollment; and finally, those selected should demonstrate signs of moderately/severely active UC as assessed by the modified Mayo Score."

Answered by AI

Is there an extensive network of medical sites within the United States currently hosting this research?

"This research is conducted at Weill Cornell Medical College, CMIIM Centre médical L'Enjeu, Gastroenterology and Internal Medicine Research Institute (GIRI), as well as 79 distinct other centers throughout North America."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
2022. "A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05242484.
All > Ulcerative Colitis > Colitis
~223 spots leftby May 2025
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