Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects with Active Proliferative Lupus Nephritis

Phase 1

• Conditions: upus Nephritis; MedDRA version: 21.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-001442-29-IT
• Lead Sponsor: ASTRAZENECA AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age 18 through 70 years at the time of screening
2. Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be:
a. Positive antinuclear antibody (ANA) test (1:40 or higher) or
b. Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the central laboratory or
c Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory
3.Class III (±class V) or class IV (±class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period
4. Urine protein to creatinine ratio >1 mg/mg (113.17 mg/mmol), obtained on a 24-hour urine collection at both:
- The start of screening and
- Within 14 days prior to the expected date of randomisation. Without the results of the second (stratification) sample, subjects cannot be randomised.
5. Estimated glomerular filtration rate =35 mL/min/1.73 m2
6. Must not have active or untreated latent TB on either chest radiograph or by Quantiferon gold test
7. Women of childbearing potential must have a negative serum betahCG test at screening and negative urine pregnancy test prior to administration of investigational product and prior to the first dose of sponsor-provided MMF

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Receipt of any investigational product (small molecule or biologic) or commercially available biologic agent within four weeks or 5 half lives prior to signing of the ICF, whichever is greater
2. Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period
3. Known intolerance to =1.0 gm/day of MMF
4. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant)
within a 6 month period after enrolment
5. Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy
(a) Oral corticosteroids >0.5 mg/kg/day for more than 8 weeks or
(b) Oral or IV pulse methylprednisolone >3.0 gm (cumulative dose) or
(c) IV cyclophosphamide >2 pulses of high dose
(=0.5 gm/m2) or >4 doses of low-dose (500 mg every 2 weeks) or
(d) Average MMF >2.5 gm/day (or >1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or
(e) Tacrolimus >4 mg/day for more than 8 weeks
6. Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period
7. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF
8. Confirmed positive test for hepatitis B or hepatitis C
9. Any severe herpes infection at any time prior to randomization
10.Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization
11. History of cancer, apart from:
a. Squamous or basal cell carcinoma of the skin
that has been successfully treated
b. High-grade squamous intraepithelial lesion (CIN III, CIS) treated with apparent success with curative therapy =1 year prior to randomisation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified