A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02411136

Enrollment

Registered

2015-04-08

Start date

2005-05-31

Completion date

2007-10-31

Last updated

2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Brief summary

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.

Interventions

DRUGAMG 623

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

DRUGPlacebo

Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Men and women between the ages of 18 and 65 years old * Diagnosis of SLE * Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization * SLE disease duration of at least 1 year, as diagnosed by a physician

Exclusion criteria

* Current renal disease * Signs or symptoms of viral or bacterial infection within 30 days of enrollment * Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere the study evaluation, completion and/or procedures per the investigator's discretion * Administration of more than 10 mg/day prednison (or equivalent) in the 30 days prior to randomization

Design outcomes

Primary

Measure	Time frame
Incidence of treatment emergent adverse events	up to 31 weeks
Incidence of abnormal clinically significant vital signs	up to 31 weeks
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results	up to 31 weeks
Incidence of abnormal clinically significant ECG results	up to 31 weeks

Secondary

Measure	Time frame
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax	up to 31 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026