Last updated: 05/21/2026 18:10:08

Indirect treatment comparison (ITC) of Belimumab vs. Obinutuzumab in Lupus Nephritis (LN)

GSK study ID
224071
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Indirect treatment comparison (ITC) of Belimumab vs. Obinutuzumab in Lupus Nephritis (LN)
Trial description: This study compares two treatments, belimumab and obinutuzumab, used for adults with lupus nephritis, a serious kidney disease caused by lupus. Because no trials have directly compared these medicines, the study will indirectly compare their safety and effectiveness using results from previously completed clinical trials. Only existing, anonymized data will be analyzed, and no new participants will be enrolled. The study focuses on patients who received standard background treatment and evaluates serious side effects, serious infections, and improvement in kidney function. The results aim to support better treatment decision-making.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of Participants with Any Serious Adverse events

Timeframe: From treatment initiation through Week 76 (REGENCY trial) and through Week 104 (BLISS-LN trial)

Proportion of Participants with Any Serious Infections

Timeframe: Up to Week 76 (REGENCY trial)

Secondary outcomes:

Proportion of Participants Achieving Complete Renal Response

Timeframe: At Week 76 (REGENCY trial)

Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Other
Primary completion date:
2026-22-06
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Lupus Nephritis
Product
belimumab
Collaborators
Not applicable
Study date(s)
June 2026 to June 2026
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Diagnosis of lupus nephritis associated with systemic lupus erythematosus
  • Histologically confirmed kidney biopsy class III or IV lupus nephritis, with or without concomitant class V disease, based on the International Society of Nephrology and Renal Pathology Society classification
  • Participants without a confirmed diagnosis of lupus nephritis
  • Participants with pure class V lupus nephritis without class III or IV involvement
Inclusion and exclusion criteria
Inclusion criteria:

    Diagnosis of lupus nephritis associated with systemic lupus erythematosus

    • Histologically confirmed kidney biopsy class III or IV lupus nephritis, with or without concomitant class V disease, based on the International Society of Nephrology and Renal Pathology Society classification
    • Receipt of mycophenolate mofetil (MMF) as standard of care background therapy in the source clinical trial
    • Enrollment in one of the previously completed randomized controlled trials included in the analysis (BLISS LN or REGENCY)
    • Availability of relevant aggregate efficacy and safety outcome data for indirect treatment comparison analyses
Exclusion criteria:

    Participants without a confirmed diagnosis of lupus nephritis

    • Participants with pure class V lupus nephritis without class III or IV involvement
    • Participants who received cyclophosphamide or other background therapies not aligned with the MMF‑only subpopulations used for analysis
    • Participants not included in the modified intention‑to‑treat (mITT) population of BLISS‑LN or the intention‑to‑treat (ITT) population of REGENCY
    • Individuals for whom relevant outcome data were unavailable or insufficient for inclusion in the indirect treatment comparison

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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