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A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (DUET-CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05242471
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: Guselkumab Biological: Golimumab Biological: JNJ-78934804 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 715 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 Crohn's Disease
Actual Study Start Date : July 22, 2022
Estimated Primary Completion Date : May 27, 2025
Estimated Study Completion Date : March 27, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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.




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 is based on the Crohn's Disease Activity Index (CDAI).

  2. Percentage of Participants with Endoscopic Response at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).


Secondary Outcome Measures :
  1. Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.

  2. Percentage of Participants with Endoscopic Remission at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD.

  3. 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 is based on the Crohn's Disease Activity Index (CDAI).

  4. Percentage of Participants with Endoscopic Response at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants with endoscopic response at Week 24 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).

  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 concentrations 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.



Information from the National Library of Medicine

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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:

  • Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
  • 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
  • If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

  • Complications of CD that may be anticipated to require surgery
  • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
  • Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
  • Has a draining (example, functioning) stoma or ostomy
  • Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
  • 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

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): NCT05242471


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
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05242471    
Other Study ID Numbers: CR109178
2021-003314-39 ( EudraCT Number )
78934804CRD2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: March 27, 2024
Last Verified: March 2024
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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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Golimumab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs