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

• ClinicalTrials.gov Identifier: NCT05242471
• Recruitment Status: Recruiting
• First Posted: February 16, 2022
• Last Update Posted: April 24, 2024
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Tracking Information

• First Submitted Date: February 15, 2022
• First Posted Date: February 16, 2022
• Last Update Posted Date: April 24, 2024
• Actual Study Start Date: July 22, 2022
• Estimated Primary Completion Date: May 27, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2022)

• 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).
• 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).

Original Primary Outcome Measures (submitted: February 15, 2022)

• 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).
• 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).

Current Secondary Outcome Measures (submitted: October 6, 2022)

• 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.
• 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.
• 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).
• 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).
• 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.
• 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.
• 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.
• 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.
• Percentage of Participants with Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
  Percentage of participants with antibodies to guselkumab will be reported.
• Titers of Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
  Titers of antibodies to guselkumab will be reported.
• Percentage of Participants with Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
  Percentage of participants with antibodies to golimumab will be reported.
• Titers of Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
  Titers of antibodies to golimumab will be reported.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: February 15, 2022)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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 guselkumab using a validated, specific, and sensitive method.
• Percentage of Participants with Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
  Percentage of participants with antibodies to guselkumab will be reported.
• Titers of Antibodies to Guselkumab [ Time Frame: Up to Week 48 ]
  Titers of antibodies to guselkumab will be reported.
• Percentage of Participants with Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
  Percentage of participants with antibodies to golimumab will be reported.
• Titers of Antibodies to Golimumab [ Time Frame: Up to Week 48 ]
  Titers of antibodies to golimumab will be reported.
• 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.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
• 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
• Brief Summary: The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Crohn's Disease

Intervention

• Biological: Guselkumab
  Guselkumab will be administered as subcutaneous injection.
• Biological: Golimumab
  Golimumab will be administered as subcutaneous injection.
• Biological: JNJ-78934804
  JNJ-78934804 will be administered subcutaneously as per defined regimen.
• Drug: Placebo
  Placebo will be administered as subcutaneous injection.

Study Arms

• 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.
  Intervention: Drug: Placebo
• 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.
  Intervention: Biological: Guselkumab
• 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.
  Intervention: Biological: Golimumab
• 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.
  Intervention: Biological: JNJ-78934804
• 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.
  Intervention: Biological: JNJ-78934804
• 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.
  Intervention: Biological: JNJ-78934804

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 14, 2022): 715
• Original Estimated Enrollment (submitted: February 15, 2022): 650
• Estimated Study Completion Date: October 8, 2030
• Estimated Primary Completion Date: May 27, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

• Listed Location Countries: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
• Removed Location Countries: Argentina, Chile, Finland, Ireland, Lithuania, Mexico, Serbia, Slovakia, Turkey

Administrative Information

• NCT Number: NCT05242471
• Other Study ID Numbers: CR109178; 2021-003314-39 ( EudraCT Number ); 78934804CRD2001 ( Other Identifier: Janssen Research & Development, LLC )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Janssen Research & Development, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Janssen Research & Development, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

• PRS Account: Janssen Research & Development, LLC
• Verification Date: April 2024