Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Screening Visit: - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active systemic lupus erythematosus (SLE) and inadequate response to standard of care (SOC) therapies including oral corticosteroid (OCS), immunosuppressants, and immunomodulators. Subjects will be randomized to receive placebo or 1 of 3 doses of Rozibafusp Alfa with the last dose at week 50. Treatment will be administered every 2 weeks (Q2W). All subjects will be required to complete a 16-week follow-up period after the 52-week treatment period. The first interim analysis (IA) will be executed after the first 40 enrolled subjects have had the opportunity to complete the week 24 assessment. Additional IAs may be executed after approximately every 32 newly enrolled subjects have had the opportunity to complete the week 24 assessment. The last IA will occur when all subjects have had the opportunity to complete the week 24 assessment.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rozibafusp Alfa, Dose A
Investigational product solution in vial
  • Drug: Rozibafusp Alfa
    Rozibafusp Alfa will be presented in 5 mL glass vial
Experimental
Rozibafusp Alfa, Dose B
Investigational product solution in vial
  • Drug: Rozibafusp Alfa
    Rozibafusp Alfa will be presented in 5 mL glass vial
Experimental
Rozibafusp Alfa, Dose C
Investigational product solution in vial
  • Drug: Rozibafusp Alfa
    Rozibafusp Alfa will be presented in 5 mL glass vial
Placebo Comparator
Placebo for Rozibafusp Alfa
Placebo Investigational product solution in vial
  • Drug: Placebo for Rozibafusp Alfa
    Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.