Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus

Completed · Phase 1 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).

Key facts

Study ID: NCT03451422
Run by: Amgen
People needed: 35
Starts: 2018-04-10
Expected to finish: 2021-10-12
Last updated by the study team: 2023-07-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants are eligible to be included in the study only if all of the following criteria apply:
Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Age ≥ 18 years to ≤ 70 years at screening.
Fulfills diagnostic criteria for SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria or by at least 4 of the 11 criteria of the 1997 American College of Rheumatology (ACR) classification criteria for SLE, with a history of at least one of the following:
Antinuclear antibody ≥ 1:80; or
Elevated anti-dsDNA antibodies
May be taking ≤ 3 systemic SLE treatments and the dose must be stable for ≥ 4 weeks prior to day 1.
Prednisone dose ≤ 20 mg daily (or other equivalent oral corticosteroid) with stable dose ≥ 2 weeks prior to day 1.
Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.
Immunizations (tetanus, diphtheria, pertussis [Td/Tdap]), seasonal influenza (during flu season), and pneumococcal (polysaccharide) vaccinations] up to date per local standards as determined by the investigator.

You may not qualify if…

Participants are excluded from the study if any of the following criteria apply.
Disease Related
History of lupus nephritis requiring induction therapy and/or lupus cerebritis ≤ 1 year prior to screening.
Other Medical Conditions
Diagnosis of inflammatory joint or skin disease other than SLE which would interfere with SLE disease assessment based on investigator judgement.
Diagnosis of fibromyalgia which would interfere with SLE assessment according to the investigator.
Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.
Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.
Known history of active tuberculosis.
Positive test for tuberculosis during screening defined as either:
positive purified protein derivative (PPD) (≥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test
a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test and negative chest X-ray.
a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening:
no symptoms per tuberculosis worksheet provided by Amgen
documented history of a completed course of adequate prophylaxis (completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product)
no known exposure to a case of active tuberculosis after most recent prophylaxis
negative chest X-ray.
Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.
Positive for Human Immunodeficiency Virus (HIV) at screening, or known to be HIV positive.
Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following:
poorly controlled diabetes or hypertension
chronic kidney disease stage IIIb, IV, or V
symptomatic heart failure (New York Heart Association class II, III, or IV)
myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
severe chronic pulmonary disease (eg, requiring oxygen therapy)

Where it is running

Pinnacle Research Group LLC — Anniston, Alabama, United States
Wallace Rheumatic Studies Center LLC — Beverly Hills, California, United States
Translational Clinical Research LLC — Aventura, Florida, United States
Northwell Health — Great Neck, New York, United States
Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center — Dallas, Texas, United States
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez — Lille, France
Hopital Europeen Marseille — Marseille, France
Hopital Pitie-Salpetriere — Paris, France
Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil — Strasbourg, France
Charite Universitätsmedizin Berlin — Berlin, Germany
Clinical Research Center Spzoo Medic-R Spolka Komandytowa — Poznan, Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne — Świdnik, Poland
Medycyna Kliniczna Marzena Waszczak - Jeka — Warsaw, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu — Wroclaw, Poland

Full record on ClinicalTrials.gov

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