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

JRCT ID: jRCT2011210060

Registered date:26/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lupus Nephritis
• Date of first enrollment: 17/08/2022
• Target sample size: 360
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Bulgaria,Japan,China,Japan,France,Japan,Germany,Japan,Hungary,Japan,India,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Peru,Japan,Poland,Japan,Russian Federation,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United States of America,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab
900 mg IV Q4W for the first 6 doses (Weeks 0 to 20) and 300 mg IV Q4W for the remainder
of the study, or matching placebo throughout during the Treatment Period.

Outcome(s)

Primary Outcome

Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group [ Time Frame: Week 52 ]
CRR is defined as:

UPCR 0.5 mg/mg or less
eGFR 60 mL/min/1.73 m2 or more, or no decrease from baseline of 20% or more

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include 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 or more (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

Exclude 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 more) 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 or less.

8. Any history of severe COVID-19 infection.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05138133