Turn a newly registered trial into a decision-ready clinical landscape. This report examines JPRN-jRCT2071260024 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.
Multiple Hamartoma Syndrome is being segmented by mechanism, treatment setting, geography and endpoint architecture. JPRN-jRCT2071260024 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.
| Field | Indexed detail |
|---|---|
| Registration | JPRN-jRCT2071260024 |
| Official title | A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease (DUET ENCORE-CD) |
| Phase / status | Phase 3 / 募集前 |
| Intervention | Guselkumab/Golimumab |
| Sponsor | Janssen Pharmaceuticals, Inc. |
| Geography | Slovakia, Taiwan Province, Italy, Malaysia, Portugal, Greece, Austria, Germany, South Korea, Brazil, Argentina, Canada, Hungary, Japan, France, United States, United Kingdom, India, Belgium, Switzerland, Turkey, Czechia, Netherlands, Poland, China, Romania, Australia, Norway |
| Enrollment | [object Object] |
| Primary endpoint | 1. 共主要評価項目:Week 48時点でclinical remissionを達成した参加者の割合 Clinical remissionは、クローン病活動性指標(CDAI)スコアが150未満(<)と定義する。CDAIスコアは0から約600の範囲である。スコアが高いほど疾患活動性が高いことを示す。 評価期間:Week 48 2. 共主要評価項目:Week 48時点でEndoscopic Remissionを達成した参加者の割合 Endoscopic Remissionは、Simple Endoscopic Score for Crohn's Disease(SES-CD)スコアが4以下( )ことと定義する。SES-CD は,5 つの回結腸セグメントにわたる,4 つの内視鏡検査の項目(潰瘍の有無/大きさ,潰瘍で覆われた粘膜表面の割合,他の病変の影響を受けた粘膜表面の割合,狭小化/狭窄の有無/種類)の評価に基づく。SES-CDスコアは0から56の範囲である。スコアが高いほど重症であることを示す。 評価期間:Week 48 |
| Endpoint time frame | Not reported |
| Primary completion / readout proxy | [object Object] |
The indexed record describes a Phase 3 study of Guselkumab/Golimumab in Multiple Hamartoma Syndrome.
Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Slovakia, Taiwan Province, Italy, Malaysia, Portugal, Greece, Austria, Germany, South Korea, Brazil, Argentina, Canada, Hungary, Japan, France, United States, United Kingdom, India, Belgium, Switzerland, Turkey, Czechia, Netherlands, Poland, China, Romania, 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.
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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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.
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.
JPRN-jRCT2071260024 provides a focused lens on Multiple Hamartoma Syndrome 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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