A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
- Summary
- The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
- Acronym
- DUET-CD
- Short 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2029-11-05
- First posted
- 2022-02-16
- Registry last updated
- 2026-08-28
- Primary completion date
- 2025-05-23
- Start date
- 2022-07-22
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Janssen Research & Development, LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05242471
- ClinicalTrials.gov ID
- NCT05242471
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percentage of Participants with Clinical Remission at Week 48
Timeframe: 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
Timeframe: 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.
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
Timeframe: 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
Timeframe: 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.
Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48
Timeframe: Week 48
Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
Timeframe: 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).
Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48
Timeframe: 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.
Percentage of Participants with Adverse Events (AEs)
Timeframe: 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)
Timeframe: 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.
Clinical Laboratory Parameters Over Time
Timeframe: Up to Week 48
Clinical laboratory parameters over time will be reported.
Vital Sign Parameters Over Time
Timeframe: Up to Week 48
Vital sign parameters over time will be reported.
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
Timeframe: 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.
Serum Concentrations of Guselkumab Over Time
Timeframe: 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
Timeframe: 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
Timeframe: Up to Week 48
Percentage of participants with antibodies to guselkumab will be reported.
Titers of Antibodies to Guselkumab
Timeframe: Up to Week 48
Titers of antibodies to guselkumab will be reported.
Percentage of Participants with Antibodies to Golimumab
Timeframe: Up to Week 48
Percentage of participants with antibodies to golimumab will be reported.
Titers of Antibodies to Golimumab
Timeframe: Up to Week 48
Titers of antibodies to golimumab will be reported.
Percentage of Participants with Neutralizing Antibodies to Guselkumab.
Timeframe: Up to Week 48
Percentage of participants with neutralizing antibodies to guselkumab will be reported.
Percentage of Participants with Neutralizing Antibodies to Golimumab
Timeframe: Up to Week 48
Percentage of participants with neutralizing antibodies to golimumab will be reported.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- No
- 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'
- University of Alabama Liver CenterBirmingham, United States
- Del Sol Research Management, LLCTucson, United States
- Moore Clinical Trials, LLCLittle Rock, United States
- Om Research LLCApple Valley, United States
- Valley Gastroenterology Medical GroupArcadia, United States
- Southern California Research CenterCoronado, United States
- Desert Gastroenterology AssociatesLancaster, United States
- Cedars Sinai Medical CenterLos Angeles, United States
- UCLALos Angeles, United States
- Hoag Memorial HospitalNewport Beach, United States
- UCI Irvine Medical CenterOrange, United States
- Medical Associates Research Group, Inc.San Diego, United States
- University of California San FranciscoSan Francisco, United States
- University of ColoradoAurora, United States
- Medical Research Center of ConnecticutHamden, United States
- Yale University School Of MedicineNew Haven, United States
- MedStar Georgetown University HospitalWashington D.C., United States
- Pioneer Research Solutions Inc.Coconut Creek, United States
- Homestead Associates in Research IncHomestead, United States
- Osceola Mental Health D/B/A Park Place Behavioral Health CareKissimmee, United States
- Florida Research Center Inc.Lakewood Rch, United States
- University of Miami HospitalMiami, United States
- Gastroenterology Group Of NaplesNaples, United States
- Omega Research ConsultantsOrlando, United States
- Synergy Clinical ResearchSt. Petersburg, United States
And 431 more, listed on the interactive page.
- 2023
- 2023-504741-32-00
- 2021-003314-39
- 78934804CRD2001
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Crohn disease Primary condition