Genakumab in Systemic Lupus Erythematosus: NCT07381465 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 4
Clinical phase
Active, not recruiting
Recruitment status
15
Planned enrollment
2027-12-20
Primary-completion proxy
Executive view
NCT07381465 evaluates Genakumab in Systemic Lupus Erythematosus. The disclosed sponsor is Chinese SLE Treatment And Research Group, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is the percentage of patients achieving an BICLA response at the end of 12 weeks, assessed over From enrollment to the end of treatment at 12 weeks.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07381465 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Systemic Lupus Erythematosus landscape. Drug & Asset MCP drug_fetch was queried for Genakumab, while Company & Deal Intelligence MCP organization_fetch was queried for Chinese SLE Treatment And Research Group.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07381465 | Genakumab | Phase 4 / Active, not recruiting | Chinese SLE Treatment And Research Group | China | the percentage of patients achieving an BICLA response at the end of 12 weeks From enrollment to the end of treatment at 12 weeks | 2027-12-20 |
| NCT07516639 | ISH-0613 | Phase 1 / Not yet recruiting | Sunho (China) Biopharmaceutical Co., Ltd. | China | Number of participants with treatment-emergent adverse events as assessed by CTCAE v6.0 baseline through day 57 | 2026-12-31 |
| NCT07517536 | CHT-105 | Not Applicable / Enrolling by invitation | Nanjing Drum Tower Hospital | China | Safety of CHT105 Injection in Subjects with Refractory Lupus Nephritis From enrollment to the end of treatment at 52 weeks | 2028-01-01 |
| NCT07512947 | YK012 | Phase 1 / Not yet recruiting | Wuhan Xiehe Hospital Tower | China | Incidence of Dose-Limiting Toxicities (DLTs) From first dose through Day 35 | 2028-03-30 |
| NCT07507201 | Universal allogeneic anti-CD19/BCMA CAR T-cells(The Children's Hospital of Zhejiang University School of Medicine) | Early Phase 1 / Recruiting | The Children's Hospital of Zhejiang University School of Medicine | China | Incidence of Dose-Limiting Toxicities (DLTs) Day 0 to Day 28 post-infusion. | 2028-12-01 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07381465 is a Phase 4, active, not recruiting study with 15 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “the percentage of patients achieving an BICLA response at the end of 12 weeks” over “From enrollment to the end of treatment at 12 weeks.” The retrieved endpoint description is: The BICLA response was defined as a reduction of all severe (BILAG-2004 A) or moderately severe (BILAG-2004 B) disease activity at baseline to lower levels (BILAG-2004 B, C, or D and C or D, respectively) and no worsening in other organ systems (with worsening defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items); no worsening in disease activity, as determined by the SLEDAI-2K score (no increase from baseline) and by the PGA score (no increase of ≥0.3 points from baseline).
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 15 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Systemic Lupus Erythematosus. These records do not establish direct evidence for NCT07381465 unless the registration number matches.
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF 06823859 IN A…
Phase 2; n=8; Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12(Least Squares Mean): Least Square Mean Difference = 0.5(90% CI, -3.7 to 4.6), P-Value = 0.8243; Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12(Least Squares Mean): Least Square Mean Difference = 0.5(90% CI, -3.7 to 4.6), P-Value = 0.8243 Source: https://clinicaltrials.gov/ct2/show/results/NCT05879718
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus
Phase 2; n=149; Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28 = 10 Participants ; Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28 = 15 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT06161116
Dapagliflozin in lupus nephritis: renal and hematologic outcomes from a randomized controlled trial
Phase 2; n=79; eGFR = -2.0 ml/min/1.73 m2 Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42549085/
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Genakumab is indexed as Monoclonal antibody with IL-1β biology and a global stage of Approved. The asset profile lists Changchun Genescience Pharmaceuticals Co., Ltd. as an originator or developer.
Chinese SLE Treatment And Research Group is indexed in China. The organization record is used to resolve sponsor identity. The record lists an unreported number of development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Genakumab is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07381465
Protocol source: https://clinicaltrials.gov/study/NCT07381465
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.
Genakumab in Systemic Lupus Erythematosus is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the percentage of patients achieving an BICLA response at the end of 12 weeks and 2027-12-20 the leading decision points.
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