Belimumab ISRCTN76569516 Clinical Landscape 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: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 3

Clinical phase

Recruiting

Recruitment status

66

Planned enrollment

2029-08-31

Primary-completion proxy

Executive view

ISRCTN76569516 evaluates Belimumab in Rheumatic Diseases. The disclosed sponsor is University College London, the design is Interventional, and the geographic footprint is United Kingdom, . The first listed primary endpoint is not reported, assessed over an unreported time frame.

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 ISRCTN76569516 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Rheumatic Diseases landscape. Drug & Asset MCP drug_fetch was queried for Belimumab, while Company & Deal Intelligence MCP organization_fetch was queried for University College London.

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
ISRCTN76569516	Belimumab	Phase 3 / Recruiting	University College London	United Kingdom,		2029-08-31
NCT07751848	Anifrolumab-FNIA	Phase 3 / Not yet recruiting	AstraZeneca PLC	China	The proportion of patients who achieve DORIS remission at week 52 Week 52	2028-08-25
NCT07749430	ACG102	Early Phase 1 / Not yet recruiting	Wuhan Xiehe Hospital Tower	Geography not reported	Incidence of dose-limiting toxicities (DLTs) Within 21 days after first dose	2027-01-30
NCT07748156	SNC116	Early Phase 1 / Not yet recruiting	Nanjing Drum Tower Hospital	China	Safety Evaluation Within 3 months after SNC116 treatment.	2030-01-01
NCT07719140	Prednisolone	Phase 4 / Recruiting	Peking Union Medical College Hospital	China	Total Renal Response at Week 24 Week 24	2028-09-01

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

ISRCTN76569516 is a Phase 3, recruiting study with 66 planned participants. Allocation is Randomized controlled trial, masking is Blinded (masking used), and the intervention model is not reported.

The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: Modified Major Clinical Response (MCR) at 52 weeks. Modified MCR is defined as a reduction in BILAG–2004 (British Isles Lupus Assessment Group-2004) index A/B scores to BILAG–2004 C/D or remain E in all domains, a reduction in steroid dose to =7.5 mg daily and a modified SLEDAI (Systemic Lupus Erythematosus Disease Activity Index 2000) –2K score =2 (without including the IgG anti-dsDNA antibody component) and no increase in immunosuppressant dose in the last 3 months before 52 weeks..

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 66 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

The protocol identifies Rituximab as control therapy. 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 Rheumatic Diseases. These records do not establish direct evidence for ISRCTN76569516 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

Efficacy and safety of enpatoran, a Toll-like receptor 7/8 inhibitor, in patients with skin manifestations of cutaneous lupus erythematosus or systemic lupus erythematosus: findin…

Phase 2; n=100; CLASI-A(16-week) = -44.0 % ( -55 to -33); CLASI-A(16-week) = -68.0 % ( -75 to -61) Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42107375/

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

Belimumab is indexed as Monoclonal antibody with BAFF biology and a global stage of Approved. The asset profile lists GSK Plc as an originator or developer.

University College London is indexed in United Kingdom with the website http://www.ucl.ac.uk. UCL is one of the world's leading universities, founded in London to open up education to all on equal terms. The record lists 62 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 Belimumab 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: ISRCTN76569516
Protocol source: https://www.isrctn.com/ISRCTN76569516
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: 16 September 2026.

Belimumab in Rheumatic Diseases is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and 2029-08-31 the leading decision points.

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