The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
3. Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
Exclusion Criteria:
1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
3. Evidence of hepatitis C or active hepatitis B.
4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
6. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
7. Known intolerance to ≤ 1.0 g/day of MMF.
8. Any history of severe COVID-19 infection.
Primary outcome measure(s)
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group — Week 52 CRR is defined as:
* UPCR ≤ 0.5 mg/mg
* eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%
Trial sites (164)
Facility
City
Region
Status
Research Site
Glendale
Arizona
Research Site
La Palma
California
Research Site
Los Angeles
California
Research Site
Upland
California
Research Site
Plantation
Florida
Research Site
Atlanta
Georgia
Research Site
Louisville
Kentucky
Research Site
Summit
New Jersey
Research Site
Manhasset
New York
Research Site
New York
New York
Research Site
Winston-Salem
North Carolina
Research Site
Middleburg Heights
Ohio
Research Site
Colleyville
Texas
Research Site
Edinburg
Texas
Research Site
El Paso
Texas
Research Site
Houston
Texas
Research Site
CABA
Argentina
Research Site
Ciudad de Buenos Aires
Argentina
Research Site
La Plata
Argentina
Research Site
Rosario
Argentina
Research Site
San Juan
Argentina
Research Site
Brussels
Belgium
Research Site
Leuven
Belgium
Research Site
Liège
Belgium
Research Site
Belo Horizonte
Brazil
Research Site
Campinas
Brazil
Research Site
Cuiabá
Brazil
Research Site
Maringá
Brazil
Research Site
Porto Alegre
Brazil
Research Site
Recife
Brazil
Research Site
Salvador
Brazil
Research Site
São José do Rio Preto
Brazil
Research Site
São Paulo
Brazil
Research Site
São Paulo
Brazil
Research Site
São Paulo
Brazil
Research Site
Plovdiv
Bulgaria
Research Site
Sofia
Bulgaria
Research Site
Beijing
China
Research Site
Beijing
China
Research Site
Bengbu
China
+ 124 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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