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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411136
• Other study ID #: 20040250
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2015
• Last updated: April 7, 2015
• Start date: May 2005
• Est. completion date: October 2007

Study information

• Verified date: April 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• AMG 623
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
• Placebo
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events		up to 31 weeks	Yes
Primary	Incidence of abnormal clinically significant vital signs		up to 31 weeks	Yes
Primary	Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results		up to 31 weeks	Yes
Primary	Incidence of abnormal clinically significant ECG results		up to 31 weeks	Yes
Secondary	Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax		up to 31 weeks	No

External Links

•   AmgenTrials clinical trials website