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

  • STATUS
    Recruiting
  • End date
    Oct 19, 2023
  • participants needed
    320
  • sponsor
    Amgen
Updated on 8 September 2021
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 Autoimmune disease, CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases
Treatment AMG 570, Placebo for AMG 570, Rozibafusp Alfa, Placebo for Rozibafusp Alfa
Clinical Study IdentifierNCT04058028
SponsorAmgen
Last Modified on8 September 2021

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
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
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 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
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 8 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
Exclusion Criteria Screening Visit
Subjects are excluded from the study if any of the following criteria apply
Disease Related
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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