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Monoclonal Antibodies
Combination Therapy for Crohn's Disease (DUET-CD Trial)
Verified 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 moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
DUET-CD Trial Summary
This trial is testing whether a new drug is better than existing drugs at treating psoriasis.
Who is the study for?
This trial is for adults with moderate to severe Crohn's Disease who haven't had success with at least one biologic treatment. They must have been diagnosed at least 3 months prior and meet specific disease activity criteria. Women of childbearing age should comply with contraception requirements. Exclusions include a recent history of cancer, certain infections, or recent surgeries.Check my eligibility
What is being tested?
The study tests the effectiveness of JNJ-78934804 against guselkumab and golimumab in treating Crohn's Disease by week 48. Participants will receive either the experimental drug (JNJ-78934804) or one of the known drugs along with a placebo to compare results.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, injection site reactions, increased risk of infection, allergic responses, and possibly others not listed here as these are common risks associated with biologic treatments for autoimmune conditions.
DUET-CD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed diagnosis of moderate to severe Crohn's disease.
Select...
I have Crohn's disease and did not respond well to at least one biologic treatment.
DUET-CD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
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
Percentage of Participants with Endoscopic Response 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 moreDUET-CD 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
976 Previous Clinical Trials
6,383,977 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,959,563 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Crohn's disease and did not respond well to at least one biologic treatment.I have or might have an abscess, but if it was drained and treated properly, I can still participate.I have not had major surgery or bowel resection in the past 6 months.I have a history of or currently have a chronic infection.I have been diagnosed with Crohn's disease for at least 3 months.I have a confirmed diagnosis of moderate to severe Crohn's disease.I might need surgery for my Crohn's disease complications.I have a working stoma or ostomy.I have Crohn's disease and treatments so far haven't worked or caused side effects.You are of childbearing potential and must be using a method of contraception.I am following the required birth control measures.I haven't had cancer, except for non-dangerous skin or cervical cancer, in the last 5 years.I have been diagnosed with Crohn's disease for at least 3 months.I have a confirmed diagnosis of moderate to severe Crohn's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Group 6: JNJ-78934804 (Low-dose)
- Group 2: Group 2: Guselkumab
- Group 3: Group 3: Golimumab
- Group 4: Group 1: Placebo
- Group 5: Group 4: JNJ-78934804 (High-dose)
- Group 6: Group 5: JNJ-78934804 (Mid-dose)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Crohn's Disease Patient Testimony for trial: Trial Name: NCT05242471 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can adults under the age of sixty join this research effort?
"To be considered for this medical trial, participants must not have exceeded the age of 65 and must possess the legal capacity to give informed consent."
Answered by AI
What is the cutoff for participant enrollment in this medical experiment?
"This trial necessitates the enrollment of 715 eligible participants, who may register at Medical University of South carolina in Charleston or Gastroenterology Associates of Orangeburg, SC."
Answered by AI
Is it feasible for me to participate in this experiment?
"This clinical trial seeks 715 volunteers affected by Crohn's disease between 18-65 years of age. The inclusion criteria are as follows: Must have a documented inadequate response, loss of response or intolerance to one biologic approved for treating Crohn's; females must meet contraception and reproductive requirements; confirmed diagnosis of moderate to severe CD assessed using CDAI, SF, AP score and SES-CD scores with a minimum duration of 3 months prior to baseline assessment."
Answered by AI
What is the current count of medical centers involved in this trial?
"This trial is being supervised from Medical University of South carolina in Charleston, Gastroenterology Associates of Orangeburg and Digestive Disease Associates Rock Hill. There are also 100 additional sites where patients can be enrolled for this study."
Answered by AI
What outcomes is this clinical trial striving to achieve?
"The primary end-point of this medical study, which will be evaluated after 48 weeks, is the Percentage of Participants with Endoscopic Response at Week 48. Secondary aims include evaluating Serum Concentrations of Guselkumab Over Time (via a validated and sensitive method), determining the prevalence of Neutralizing Antibodies to Golimumab in participants, as well as calculating Titers of Antibodies to Guselkumab."
Answered by AI
Does this research project currently have any openings for new participants?
"Yes, according to the clinicaltrials.gov database, this medical experiment is actively recruiting patients and has been since July 22nd 2022. The trial's information was most recently revised on November 3rd of that same year with a total enrollment target of 715 individuals from 100 various sites."
Answered by AI
Are there any safety concerns associated with JNJ-78934804 for patients?
"Due to the fact that JNJ-78934804 is in Phase 2 of clinical trials, our team has rated its safety at a 2 - there are some studies showing it's safe but none confirming efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
Texas
How old are they?
18 - 65
What site did they apply to?
Amel Med LLC. Research
Tri-State Gastroenterology Assoc
Accurate Clinical Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I have been living with this disease my entire life. I was missed diagnosed countless times and even told once it was all in my head. I'm willing to help anyway I can if it may result in somebody in the future not having to deal with what I have had to. The quicker Doctors are able to cure or prevent this disease and it's side effects the better off future CD patients will be.
PatientReceived 2+ prior treatments
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