Active — Not RecruitingPhase 3

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

United States359 participantsStarted 2022-02-15

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group

Timeframe: Week 52

NCT IDNCT05138133

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-26

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.