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 19 August 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 systemic lupus erythematosus (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 on19 August 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
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
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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note