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TREMFYA® (guselkumab)

Medical Information

JNJ-78934804 (Golimumab and Guselkumab) vs SIMPONI or TREMFYA

Last Updated: 04/07/2026

summary

The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
DUET-CD (NCT05242471)¹ is an ongoing, phase 2b randomized, double-blind, active-and placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of subcutaneous (SC) guselkumab and golimumab combination therapy vs TREMFYA or golimumab monotherapy in adult patients with moderately to severely active Crohn’s disease (CD).

CLINICAL DATA

Phase 2 Study: DUET-CD

DUET-CD (NCT05242471)¹ is an ongoing, phase 2b randomized, double-blind, active-and placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of SC guselkumab and golimumab combination therapy vs TREMFYA or golimumab monotherapy in adult patients with moderately to severely active CD.

Study Design/Methods

Group 1: Placebo SC
Experimental Groups (SC administration):
- Group 2: TREMFYA SC
- Group 3: Golimumab SC
- Group 4: High-dose of SC combination therapy of guselkumab and golimumab
  (JNJ-78934804)
- Group 5: Mid-dose of SC combination therapy of guselkumab and golimumab
  (JNJ-78934804)
- Group 6: Low-dose of SC combination therapy of guselkumab and golimumab
  (JNJ-78934804).
Patients who meet inadequate response criteria will be escalated to an active treatment.
Patients who are eligible and willing to continue the study intervention at week 44 may enter the long-term extension.
The efficacy and safety outcomes to be evaluated are summarized in Table: Efficacy and Safety Outcome Measures.

Efficacy and Safety Outcome Measures¹

Study Outcomes
Primary efficacy outcome at week 48
Clinical remission based on the CDAI score
Endoscopic response based on the SES-CD score
Selected Secondary efficacy outcomes at week 48
Endoscopic response based on the SES-CD score Corticosteroid-free (60-day) clinical remission Clinical remission based on the CDAI score Endoscopic remission based on SES-CD score PRO-2 Remission based on average daily AP and SF scores
Safety will be evaluated up to week 48.
Abbreviations: AP, abdominal pain; CDAI, Crohn’s Disease Activity Index; PRO-2, Patient-reported outcomes; SES-CD score, Simple Endoscopic Score for Crohn’s disease; SF, stool frequency.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 18 March 2026.

References

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Janssen Research and Development, LLC. A study of combination therapy with guselkumab and golimumab in participants with moderately to severely active Crohn’s disease (DUET-CD). In ClinicalTrials.gov [Internet]. Bethesda (MD). National Library of Medicine (US). 2000- [cited 2026 March 18]. Available from https://clinicaltrials.gov/study/NCT05242471

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