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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Active Systemic Lupus Erythematosus

In brief

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

Key facts

Study ID: NCT04680637
Run by: Amgen
People needed: 168
Starts: 2021-05-06
Expected to finish: 2023-05-22
Last updated by the study team: 2024-06-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Participant is aged between 18 and 75.
Fulfills classification criteria for systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening.
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 or immunologic parameters.
British-Isles Lupus Assessment Group (BILAG) index score (BILAG 2004) of ≥ 1 A item or ≥ 2 B items.
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 participant may enter the study on OCS alone (prednisone ≥ 10 mg/day or equivalent) only if the participant has previously documented trial of anti-malarial or immunosuppressant treatment for SLE. Participants 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.
For participants taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit and for ≥ 2 weeks prior to screening visit.
Stability of SLE treatments: OCS and other immunosuppressants/immunomodulator agents and doses must be stable since screening visit.
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 laboratory results including urine and immunologic parameters).

You may not qualify if…

Lupus nephritis if any of the following are present: urine protein creatinine ratio ≥ 2000 mg/g (or equivalent) at screening, OR requiring induction therapy currently or within 1 year prior to screening, OR histological evidence (if available) of diffuse proliferative glomerulonephritis within 12 weeks 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.
Currently present or within 1 year prior to screening a diagnosis of any chronic inflammatory disease other than SLE (eg, rheumatoid arthritis) which would interfere with SLE disease assessment.
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 (including chronic or localized infections) 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.
Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.
Positive test for tuberculosis during creening 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).
Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb). A history of hepatitis B vaccination without history of hepatitis B infection (ie, positive hepatitis B surface antibody (HBsAb), negative HBsAg and negative HBcAb) is allowed.
Positive for hepatitis C antibody.
Known history of HIV or positive HIV test at screening.
Presence of 1 or more significant concurrent medical conditions, including but not limited to the following:
poorly controlled diabetes (hemoglobin A1C > 7) or hypertension
symptomatic heart failure (New York Heart Association class III or IV)
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
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
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 screening.
Currently receiving or had treatment with a Janus kinase (JAK) inhibitor within 3 months or less than 5 drug half-lives (whichever is longer) prior to screening.
Currently receiving or had treatment with an immune checkpoint inhibitor (eg, programmed death 1 [PD-1] inhibitor, programmed death ligand 1 [PD-L1] inhibitor, cytotoxic T-lymphocyte associated protein 4 [CTLA-4] inhibitor).
Note: Abatacept is not considered a CTLA-4 inhibitor and is referred to below.
Currently receiving or had treatment within 12 months prior to screening with T-cell depleting agents (eg, antithymocyte globulin, Campath).

Where it is running

Arizona Arthritis and Rheumatology Associates PC — Gilbert, Arizona, United States
Arizona Arthritis And Rheumatology Associates PC — Glendale, Arizona, United States
Arizona Arthritis and Rheumatology Associates PC — Tucson, Arizona, United States
Loma Linda University Health Care — Loma Linda, California, United States
University of California Los Angeles — Los Angeles, California, United States
University of California Irvine — Orange, California, United States
Robin K Dore MD Inc — Tustin, California, United States
Arthritis and Rheumatic Disease Specialties — Aventura, Florida, United States
Life Clinical Trials — Aventura, Florida, United States
Centre for Rheumatology Immunology and Arthritis — Fort Lauderdale, Florida, United States
GNP Research — Hollywood, Florida, United States
Millennium Research — Ormond Beach, Florida, United States
Integral Rheumatology and Immunology Specialists — Plantation, Florida, United States
Suncoast Medical Clinic — St. Petersburg, Florida, United States
Baycare Medical Group Inc — Tampa, Florida, United States
University of Chicago — Chicago, Illinois, United States
Greater Chicago Specialty Physicians — Schaumburg, Illinois, United States
Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc — Skokie, Illinois, United States
Western Kentucky Rheumatology PLLC — Hopkinsville, Kentucky, United States
Accurate Clinical Research — Lake Charles, Louisiana, United States
Michigan Rheumatology Group, PC - Grand Blanc Office — Grand Blanc, Michigan, United States
Arthritis and Rheumatology of Michigan — Lansing, Michigan, United States
New York University Langone Ambulatory Care Brooklyn Heights — Brooklyn, New York, United States
Feinstein Institute for Medical Research — Manhasset, New York, United States
University of Alabama at Birmingham,Arthritis Clinical Intervention Program — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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