JPRN-jRCT2031260126 Guselkumab/Golimumab Ulcer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines JPRN-jRCT2031260126 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 22 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why JPRN-jRCT2031260126 is a hot trial to watch
Ulcer is being segmented by mechanism, treatment setting, geography and endpoint architecture. JPRN-jRCT2031260126 is notable because it evaluates Guselkumab/Golimumab in a Phase 3 design sponsored by Janssen Pharmaceuticals, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | JPRN-jRCT2031260126 |
| Official title | A Phase 3 Randomized, Double-blind, and Active controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis (DUET ENCORE-UC) |
| Phase / status | Phase 3 / 募集前 |
| Intervention | Guselkumab/Golimumab |
| Sponsor | Janssen Pharmaceuticals, Inc. |
| Geography | Slovakia, Taiwan Province, Bulgaria, Italy, Malaysia, Portugal, Greece, Austria, Germany, United Kingdom, South Korea, Brazil, Argentina, Canada, Hungary, Japan, France, India, Netherlands, Belgium, Switzerland, Turkey, United States, Mexico, Czechia, Poland, China, Romania, Denmark, Australia, Norway |
| Enrollment | [object Object] |
| Primary endpoint | 1. Percentage of Participants in Clinical Remission at Week 48 Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, an rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1. Time Frame: At Week 48 |
| Endpoint time frame | Not reported |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The indexed record describes a Phase 3 study of Guselkumab/Golimumab in Ulcer.
Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Slovakia, Taiwan Province, Bulgaria, Italy, Malaysia, Portugal, Greece, Austria, Germany, United Kingdom, South Korea, Brazil, Argentina, Canada, Hungary, Japan, France, India, Netherlands, Belgium, Switzerland, Turkey, United States, Mexico, Czechia, Poland, China, Romania, Denmark, Australia, Norway shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- 1. Percentage of Participants in Clinical Remission at Week 48 Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, an rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1. Time Frame: At Week 48 (time frame not reported)
- 1. Week 48時点でClinical remissionを達成した参加者の割合 Clinical remissionとは、排便回数（SF）サブスコアが0又は1、直腸出血（RB）サブスコアが0、及び内視鏡サブスコアが0又は1であることと定義する。 評価期間：Week 48 (time frame not reported)
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Guselkumab/Golimumab is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Janssen Pharmaceuticals, Inc. did not return an exact normalized organization match in this snapshot. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
JPRN-jRCT2031260126 provides a focused lens on Ulcer development. Its value will be determined by whether Guselkumab/Golimumab can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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