Lupus & antiphospholipid syndrome
Clinical and Biomarker Responses to BI 655064, an Antagonistic Anti‐CD40 Antibody, in Patients With Active Lupus Nephritis: A Randomized, Double‐Blind, Placebo‐Controlled, Phase II Trial
Authors' conclusion
The trial failed to demonstrate a dose-response relationship for the primary CRR endpoint.
Study context
- Population
- Patients with active lupus nephritis (LN) receiving mycophenolate and GC
- Participants
- 121 patients
- Comparison
- BI 655064 120, 180 or 240 mg vs placebo, added to mycophenolate and GC
- Primary endpoint
- Complete renal response (CRR)
- Follow-up
- Week 52
Methodological detailsdouble-blind, placebo-controlled, phase II, dose-ranging
- Double-blind
- Placebo-controlled
- Phase II
- Dose-ranging
Primary result
As reported in the abstract
CRR
Secondary outcomes
CRR · week 26
Confirmed CRR (cCRR, at weeks 46 and 52) · post hoc analysis
Safety
- ≥1 adverse event — Placebo
- 97.5%
- Infections and infestations (most frequent AEs) — Placebo
- 60%
- Serious infections — 240 mg
- 20%
- Severe infections — 240 mg
- 10%
- ≥1 adverse event — BI 655064 (all doses)
- 85.7-95.0%
- Infections and infestations (most frequent AEs) — BI 655064 (all doses)
- 61.9-75.0%
- Serious infections — Other groups
- 7.5-10%
- Severe infections — Other groups
- 4.8-5.0%
Original publication
Clinical and Biomarker Responses to BI 655064, an Antagonistic Anti‐CD40 Antibody, in Patients With Active Lupus Nephritis: A Randomized, Double‐Blind, Placebo‐Controlled, Phase II Trial. Arthritis Rheumatol. Published 17 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →