A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

  • End date
    Jul 19, 2024
  • participants needed
  • sponsor
Updated on 10 October 2022
antinuclear antibody
mouth ulcer


The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.


This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and immunomodulators. Previous biologic use is allowed with an adequate washout period.

Condition Systemic Lupus Erythematosus (SLE)
Treatment AMG 570, Placebo for AMG 570, Rozibafusp Alfa, Placebo for Rozibafusp Alfa
Clinical Study IdentifierNCT04058028
Last Modified on10 October 2022


Yes No Not Sure

Inclusion Criteria

Subject has provided informed consent prior to initiation of any study-specific activities/procedures
Age ≥ 18 years to ≤ 75 years at screening visit
Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening
Hybrid SLEDAI score ≥ 6 points with a "Clinical" hSLEDAI score ≥ 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters
Additional protocol-specific rules are applied at screening and throughout the study, as follows
Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring
Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia ≥ 2
Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded
Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI ≥ 4 and did not receive induction treatment for nephritis within the last year
Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI
Oral ulcers: Ulcers location and appearance must be documented by the investigator
Unless there is a documented intolerance, subjects must be taking
Only 1 of the following SLE treatments: anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone
• 2 of the above-mentioned SLE treatments in which 1 must be anti-malarial
(hydroxychloroquine, chloroquine, or quinacrine)
Treatment should be taken for ≥ 12 weeks prior to screening and must be a stable dose
Exclusion Criteria Screening Visit
for ≥ 8 weeks prior to screening
Subjects are excluded from the study if any of the following criteria apply
For subjects taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and
Disease Related
the dose must be stable at baseline visit for ≥ 2 weeks prior to screening visit
Urine protein creatinine ratio ≥ 3000 mg/g (or equivalent) at screening or induction
therapy for lupus nephritis within 1 year prior to screening visit
Active CNS lupus within 1 year prior to screening including, but not limited to
aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating
syndrome, optic neuritis, psychosis, seizures, or transverse myelitis
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