A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05138133Tipo: INTERVENTIONALInicio: 15 de feb de 2022Fin estimado: 5 de dic de 2028

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

Descripción detallada

This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study with OLE is to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 142 weeks, including screening and follow-up. Double-blind period will be 76 weeks. Participants who complete double-blind treatment period may enter open-label extension to receive anifrolumab for up 52 weeks. Approximately 360 of the enrolled participants will be randomly assigned to study intervention (anifrolumab or placebo) at a ratio of 1:1 during double-blind treatment period.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
Fulfills updated 2019 EULAR/ACR SLE classification criteria.
No signs of symptoms of active TB prior to or during screening or no treatment for latent TB

Criterios de exclusión

A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
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).
Evidence of hepatitis C or active hepatitis B.
Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
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.
Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
Known intolerance to ≤ 1.0 g/day of MMF.
Any history of severe COVID-19 infection.

Intervenciones

drug

Anifrolumab

Anifrolumab intravenous infusion (IV)

drug

Placebo

Placebo intravenous infusion (IV)

Ubicaciones

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

Patrocinadores

PrincipalAstraZeneca

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