A 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
- Conditions
- Active Systemic Lupus Erythematosus (SLE)MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-000328-16-IT
- Lead Sponsor
- AMGEN INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 320
- 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. Anti-dsDNA results based on the Farr assay will be used to SLE classification criteria, while test results from the Phadia method will be used for the purposes of hSLEDAI scoring during screening and throughout the study
- Hybrid SLEDAI-2K score > = 6 points with Clinical hSLEDAI-2K score > = 4 points.
The Clinical hSLEDAI-2K is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results including urine or immunologic parameters.
Additional protocol specific rules:
o 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
*Please, refer to protocol for the full list
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 295
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
- Urine protein creatinine ratio >= 3000mg/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.
- Diagnosis of any inflammatory joint or skin disease other than SLE (confirmed accurate by the PI) which would interfere with SLE disease assessment based on investigator judgement.
- Any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 6 weeks prior to screening.
*Please, refer to protocol for the full list
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the efficacy of AMG 570 at week 52 as measured by the Systemic Lupus Erythematosus Responder Index (SRI-4);Secondary Objective: - Evaluate the efficacy of AMG 570 at week 24 <br>- Evaluate the efficacy of AMG 570 at week 52<br>- Evaluate the efficacy of AMG 570 as measured by SRI-4 response with oral corticosteroid (OCS) tapering <br>- Evaluate the efficacy of AMG 570 on disease flares<br>- Evaluate the efficacy of AMG 570 on joints and skin.<br>- Describe the efficacy of AMG 570 using patient reported outcomes.<br>- Characterize the safety of AMG 570.<br>- To characterize the pharmacokinetics (PK) of AMG 570.;Primary end point(s): SRI-4 response at week 52;Timepoint(s) of evaluation of this end point: Week 52
- Secondary Outcome Measures
Name Time Method