Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus

Phase 1

• Conditions: MedDRA version: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859; Active Systemic Lupus Erythematosus; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-003509-72-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- Age >= 18 years to 75 years at screening
- 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. AntidsDNA results based on the Phadia method will be used for SLE classification criteria and for the purposes of hSLEDAI scoring during screening and throughout the study
- 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 and immunologic parameters. Including the following protocol specific rules: - Arthritis: for hSLEDAI scoring purposes, arthritis must involve small joints in the hands or wrists. - 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 (ie, that will likely not require initiation/increase in immunosuppressants/immunomodulators as outlined in the inclusion/exclusion criteria) must be documented by an ophthalmologist and other causes excluded. - Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent) in a clean catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI >= 4. - Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI

*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 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

Exclusion Criteria

- Lupus nephritis with urine protein creatinine ratio > 3000 mg/g at screening or having required induction therapy within 1 year prior to screening.
- 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.
Other Medical Conditions:
- Currently present or within 1 year prior to screening a diagnosis of any inflammatory joint or skin disease other than SLE which would interfere with SLE disease assessment based on investigator judgement.
- History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 4 months prior to screening.
- Active infection for which anti-infectives were indicated within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.
- Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.

*Please refer to the protocol for the full list

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified