CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 244 enrolled
Drug / intervention
Rozibafusp Alfa +1 moredrug
Likely dose
Rozibafusp Alfa 5 mLfrom record
Key inclusion· 5
  • ✓Age 18-75 years at screening
  • ✓Meets 2019 EULAR/ACR classification criteria for SLE with ANA ≥1:80 by immunofluorescence on Hep-2 cells
  • ✓Hybrid SLEDAI score ≥6 with Clinical hSLEDAI ≥4
  • ✓On stable background SLE therapy: either 1 of (anti-malarial, azathioprine, methotrexate, leflunomide, mycophenolate, or dapsone) OR 2 including an anti-malarial, stable ≥8 weeks
Key exclusion· 3
  • ✕Urine protein-to-creatinine ratio ≥3000 mg/g (severe renal proteinuria)
  • ✕Induction therapy for lupus nephritis within 1 year prior to screening
  • ✕Active CNS lupus within 1 year prior to screening (meningitis, ataxia, vasculitis, cranial neuropathy, demyelination, optic neuritis, psychosis, seizures, transverse myelitis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04058028
NCT04058028Phase 2Completed
CompareCT.gov

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

Amgen·interventional·Posted Aug 15, 2019·Updated Sep 24, 2024

In Brief

A Phase 2 clinical trial evaluating Rozibafusp Alfa and Placebo for Rozibafusp Alfa for Systemic Lupus Erythematosus (SLE). Completed, enrolled 244 participants across 147 sites in 19 countries.

Detailed 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 SLE have ongoing disease activity despite treatment with standard of care therapies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus (SLE)
CountriesArgentina, Australia, Bulgaria, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Portugal, Russia, South Korea, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 15, 2019
Enrollment StartFeb 19, 2020
Primary CompletionJul 25, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.9 years ago

Interventions

Rozibafusp Alfadrug

Rozibafusp Alfa will be presented in 5 mL glass vial

Placebo for Rozibafusp Alfadrug

Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial