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-AT
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
Screening:
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 EULAR/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 Phadia method will be used for the purposes of hSLEDAI scoring during screening and throughout the study.
110 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, a minimum of 3 joints with pain and signs of inflammation (ie, tenderness with swelling or effusion) must involve small joints in the hands, wrists, or a combination of joints in hands and wrists.
- Alopecia: subjects should have active 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 < 2000 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.
111. For France, affiliation to a social security scheme is required.
Day 1 (Baseline):
The baseline/day 1 visit should occur after confirmation of eligibility by the adjudication 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/immunomodulator agents and doses must be stable since screening visit.
109 Disease activity: active disease as indicated by clinical hSLEDAI score = 4 must be observed (clinical hSLEDAI score is the hSLEDAI assessment score without the inclusion of points attributable to laborator
231 Lupus nephritis if any of the following are present:
urine protein creatinine ratio = 2000 mg/g at screening, OR requiring induction therapy currently or within 1 year prior to screening, OR histological evidence of diffuse proliferative glomerulonephritis within 12 weeks 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.
232 Currently present or within 1 year prior to screening a diagnosis of any chronic inflammatory disease other than SLE which would interfere with SLE disease assessment.
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 are indicated currently or 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) (= 5 mm of induration at 48 to 72 hours after test is placed).
233 Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb). A positive hepatitis B surface antibody (HBsAb) without history of hepatitis B infection (ie, positive HBsAg, negative HBsAg and negative HBcAb) is allowed.
234 Positive for hepatitis C antibody
210 Known history of HIV or positive HIV test at screening.
235 Presence of 1 or more significant concurrent medical conditions, including but not limited to the following: poorly controlled diabetes or hypertension, symptomatic heart failure, myocardial infarction or unstable angina pectoris within the past 12 months prior to screening, severe chronic pulmonary disease requiring oxygen therapy, multiple sclerosis or any other demyelinating disease.
212 Any history of malignancy with the following exceptions:
resolved non-melanoma skin cancers > 5 years prior to screening
resolved cervical carcinoma > 5 years prior to screening
resolved breast ductal carcinoma in situ > 5 years of screening
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.
237 Currently receiving or had treatment with a Janus kinase (JAK) inhibitor within 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 an IL-2 based therapy
238 Current or previous treatment with a biologic agent with immunosuppressive/immunomodulatory activity as follows: rituximab within 6 months prior to screening; abatacept, belimumab, and anifrolumab within the past 3 months prior to screening; other biologics within < 5 drug half-lives prior to screening.
219 Subjects who have received intraarticular, intralesional, or intramuscular corticosteroids within 2 we
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