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NCT Number: NCT05242471

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Queen Elizabeth Hospital, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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'

Treatment and study plan

Guselkumab

Biological

Guselkumab will be administered as subcutaneous injection.

Golimumab

Biological

Golimumab will be administered as subcutaneous injection.

JNJ-78934804

Biological

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

Placebo

Drug

Placebo will be administered as subcutaneous injection.

Primary outcomes

  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), as assessed by central endoscopy reading.

Secondary outcomes

  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, as assessed by central endoscopy reading.

  3. Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48

    Time frame: Week 48

    Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.

  4. Secondary Comparison: 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).

  5. Secondary Comparison: 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 SES-CD, as assessed by central endoscopy reading.

  6. 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.

  7. 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.

  8. Clinical Laboratory Parameters Over Time

    Time frame: Up to Week 48

    Clinical laboratory parameters over time will be reported.

  9. Vital Sign Parameters Over Time

    Time frame: Up to Week 48

    Vital sign parameters over time will be reported.

  10. Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: Up to Week 48

    The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation is defined as an increase in severity of suicidal ideation from baseline.

  11. 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.

  12. 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.

  13. Percentage of Participants with Antibodies to Guselkumab

    Time frame: Up to Week 48

    Percentage of participants with antibodies to guselkumab will be reported.

  14. Titers of Antibodies to Guselkumab

    Time frame: Up to Week 48

    Titers of antibodies to guselkumab will be reported.

  15. Percentage of Participants with Antibodies to Golimumab

    Time frame: Up to Week 48

    Percentage of participants with antibodies to golimumab will be reported.

  16. Titers of Antibodies to Golimumab

    Time frame: Up to Week 48

    Titers of antibodies to golimumab will be reported.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Acronym: DUET-CD

Important dates

Study start
2022
Primary completion
2025
Study completion
2029
First posted
Feb 16, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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