Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus
- Conditions
- Active Systemic Lupus ErythematosusMedDRA version: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2020-003509-72-ES
- 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
Inclusion Criteria - Screening Visit
101 Subject has provided informed consent prior to initiation of any study specific activities/procedures.
102 Age = 18 years to 75 years at screening.
103 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.
104 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.
105 BILAG index score (BILAG 2004) of = 1 A item or = 2 B items.
106 Must be taking = 1 of the following SLE treatments (or regional equivalent): hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil, azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or OCS. A subject may enter the study on OCS alone (prednisone ? 10 mg/day or equivalent) only if the subject has previously documented trial of anti-malarial or immunosuppressant treatment for SLE. Subjects must be on a stable dose for = 8 weeks prior to screening for all antimalarials and immunosuppressants, with the exception of OCS doses which must be stable for = 2 weeks prior to screening.
107 For subjects taking OCS, the dose must be = 20 mg/day of prednisone or OCS equivalent, and the dose must be stable for = 2 weeks prior to screening visit.
Inclusion Criteria - Day 1 (Baseline)
The baseline/day 1 visit should occur after confirmation of eligibility by the Central Review Team within 33 days after the screening visit. At the baseline/day 1 visit, the following 2 criteria should be assessed prior to randomization:
108 Stability of SLE treatments: OCS and other immunosuppressants/ immunomodulators doses must be stable since screening visit, by reviewing subject’s medication history.
109 Disease activity: active disease as indicated by clinical hSLEDAI score = 4 must be observed
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 o
Subjects are excluded from the study if any of the following criteria apply:
201 Lupus nephritis with urine protein creatinine ratio ? 3000 mg/g at screening or having required induction therapy within 1 year prior to screening.
202 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
203 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.
204 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.
205 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.
206 Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.
207 Positive test for tuberculosis during screening defined as: either a positive or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD).
208 Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) in the presence of detectable viral DNA in peripheral blood
209 Positive for hepatitis C antibody in the presence of detectable viral RNA in peripheral blood
210 Known history of HIV or positive HIV test at screening.
211 Presence of 1 or more significant concurrent medical conditions per investigator judgment
212 Any history of malignancy
213 Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent within 6 months prior to screening or sirolimus within 4 weeks prior to screening.
214 Currently receiving or had treatment with a JAK inhibitor within 3 months or less than 5 drug half-lives prior to screening.
215 Currently receiving or had treatment with an immune checkpoint inhibitor
216 Currently receiving or had treatment within 12 months prior to screening with T-cell depleting agents.
217 Currently receiving or had treatment with recombinant IL-2.
218 Current or previous treatment with a biologic agent
219 Subjects who have received intraarticular, intralesional, or intramuscular corticosteroids within 2 weeks prior to screening or intravenous corticosteroids within 6 weeks prior to screening.
220 Subjects who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines during the treatment period and up to 6 weeks after the end of treatment period in the study.
221 Currently receiving treatment in another investigational device or drug study.
222 Ending a treatment with an investigational drug or investigational device less than 3 months or 5 half-lives from the last dose of the investigational drug at screening.
223 Presence of laboratory abnormalities at screening
224 Any other laboratory abnormality, which in the opinion of the investigator or Central Review Team, poses a safety risk, will prevent the subject from completing the study or will interfere with the interpretation of the study results, or might cause the study to
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method