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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT02411136
• Date of registration: 03/04/2015
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
• Scientific 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
• Date of first enrolment: May 2005
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02411136
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: AMG 623

Drug: Placebo

Primary Outcome(s)

Incidence of treatment emergent adverse events [Time Frame: up to 31 weeks]

Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results [Time Frame: up to 31 weeks]

Incidence of abnormal clinically significant ECG results [Time Frame: up to 31 weeks]

Incidence of abnormal clinically significant vital signs [Time Frame: up to 31 weeks]

Secondary Outcome(s)

Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax [Time Frame: up to 31 weeks]

Secondary ID(s)

20040250

Source(s) of Monetary Support

Please refer to primary and secondary sponsors