Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

  • STATUS
    Recruiting
  • End date
    Jul 19, 2024
  • participants needed
    320
  • sponsor
    Amgen
Updated on 8 August 2022
methotrexate
prednisone
hydroxychloroquine
vasculitis
arthritis
azathioprine
rheumatism
lupus
mycophenolate
chloroquine
antinuclear antibody
pericarditis
nephritis
mouth ulcer
quinacrine

Summary

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 systemic lupus erythematosus (SLE) have ongoing disease activity despite treatment with standard of care therapies.

Description

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.

Details
Condition Systemic Lupus Erythematosus (SLE)
Treatment AMG 570, Placebo for AMG 570, Rozibafusp Alfa, Placebo for Rozibafusp Alfa
Clinical Study IdentifierNCT04058028
SponsorAmgen
Last Modified on8 August 2022

Eligibility

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
Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the
hands or wrists for the hSLEDAI scoring
follows
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
Oral ulcers: Ulcers location and appearance must be documented by the investigator
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
Exclusion Criteria Screening Visit
Subjects are excluded from the study if any of the following criteria apply
nephritis within the last year
Disease Related
Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied
by objective findings to be scored in the hSLEDAI
Must be taking at least 1 but not more than 2 of the following SLE treatments
unless there is a documented intolerance to the following treatments
anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine
methotrexate, mycophenolate mofetil/acid mycophenolic, or dapsone. Treatment
should be taken for ≥12 weeks prior to screening and must be a stable dose for ≥
weeks prior to screening. If subject is taking 2 of the above mentioned SLE
treatments, 1 of these must be either hydroxychloroquine, quinacrine, or
chloroquine
For subjects taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS
equivalent, and 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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