JPRN-jRCT2031260219 Cyclosporine Coronary Artery Disease Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready landscape. This focused report examines JPRN-jRCT2031260219—An Explorative Study for Finding Optimal Indication Criteria for Immunomodulatory Therapy in Patients with Kawasaki Disease (FORKiDs trial)—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.
MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.
Why JPRN-jRCT2031260219 is a hot trial to watch
Coronary Artery Disease is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. JPRN-jRCT2031260219 is notable because it evaluates Cyclosporine in a Phase 2 design while The presence or absence of CAA through week 4 after enrollment CAA is defined as Z score >= 2.5. serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.
PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | JPRN-jRCT2031260219 |
| Official title | An Explorative Study for Finding Optimal Indication Criteria for Immunomodulatory Therapy in Patients with Kawasaki Disease (FORKiDs trial) |
| Phase / status | Phase 2 / 募集中 |
| Intervention | Cyclosporine |
| Sponsor | Not reported |
| Collaborators | Not reported |
| Geography | Taiwan Province, Japan |
| Enrollment | 343 |
| Primary endpoint | The presence or absence of CAA through week 4 after enrollment CAA is defined as Z score >= 2.5. |
| Endpoint time frame | Not reported |
| Primary completion / readout proxy | [object Object] |
Design and endpoint interpretation
The phase label is only the starting point. Allocation is Non-Randomized, masking is Open Label, and the intervention model is Single Group Assignment. Planned enrollment of 343 participants across Taiwan Province, Japan 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.
- Primary: The presence or absence of CAA through week 4 after enrollment CAA is defined as Z score >= 2.5.
- Primary: 登録後4週までのCAAを有する患者の発生頻度 Zスコア≧2.5の場合、CAAを有すると定義する
- Secondary: ＜有効性の副次評価項目＞ 1）登録後4週までのCAAを有する患者の発生頻度 Zスコア≧3.0の場合、CAAを有すると定義する 2）登録後4週までの連続値のZスコアの関連性 3）各評価時点でのCAAを有する患者の発生頻度 Zスコア≧2.5およびZスコア≧3.0の2つの閾値でCAAを有するとそれぞれ定義する 4）各評価時点での連続値のZスコア 5）以下①～④の因子による、登録後4週までのCAAを有する患者の発生頻度 Zスコア≧2.5およびZスコア≧3.0 の2つ閾値でCAAを有するとそれぞれ定義する 6）以下①～④の因子による、登録後4週までの連続値のZスコアの関連性 ① ヘマトクリット ② 総ビリルビン ③ 血中サイトカイン・ケモカイン ④ 血中Myl9値 ＜安全性の副次評価項目＞ 有害事象発生頻度
- Secondary: Efficacy secondary endpoints 1) The presence or absence of CAA through week 4 after enrollment CAA is defined as Z score >= 3.0 2) The maximum Z score (continuous variable) within 4 weeks after registration 3) Incidence of patients with CAA at each assessment time point CAA is defined separately using two thresholds: Z score >= 2.5, Z score >= 3.0 4) Maximum Z score (continuous value) at each assessment point 5) Incidence of CAA in patients with the following factors a.-d. within 4 weeks after registration CAA is defined separately using two thresholds: Z score >= 2.5, Z score >= 3.0 6) Association between Z score (continuous variable) up to 4 weeks after registration, based on the following factors a.-d. a. Hematocrit b. Total bilirubin c. Blood cytokine/chemokine levels d. Blood myl9 levels Safety secondary endpoints Frequency of occurrence of adverse events
Benchmark readouts in the surrounding field
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
- A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)
- A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (Phase 2): Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -0.4 percent change (Standard Error, 0.91); Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -9.4 percent change (Standard Error, 1.60)
These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.
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Asset and sponsor context
Drug & Asset context: Cyclosporine (Approved; CaN)
Company & Deal Intelligence context: Not reported
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 decide 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.
- Sequencing evidence: comparative data after the most 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 probability of success before a headline data release.
Bottom line
JPRN-jRCT2031260219 is a focused lens on Coronary Artery Disease development. Its value will be determined by whether Cyclosporine can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.
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