A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02291588
• Date of registration: 03/11/2014
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
• Scientific title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
• Date of first enrolment: December 2007
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02291588
• 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:

- Diagnosis of SLE ncluding a positive antinuclear antibodies (ANA) test at least 6
months before randomization; any concurrent SLE pharmacologic regimen (including
leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before
randomization; prednisone = 20 mg/day (or equivalent) was permitted; 1 increase or
decrease of = 5mg/day prednisone equivalent was allowed within 30 days before
randomization

Exclusion Criteria:

- Subjects who, in the clinical judgment of the investigator, had severe disease;
subject who had at least 1 BILAG 'A' score or 2 BILAG 'B' scores in any of the organ
systems at screening; signs or symptoms of a viral or bacterial infection within 30
days of study randomization, or recent history of repeated infections, evidence of
liver disease; concurrent receipt of mycophenolate mofetil or azathioprine; prior
administration of another biologic that primarily targets the immune system within 1
year



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

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: AMG 811

Drug: Placebo

Primary Outcome(s)

Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs [Time Frame: between 84 and 196 days]

Secondary Outcome(s)

Pharmacokinetic profile of AMG 811 including tmax, AUClast and Cmax [Time Frame: between 84 and 196 days]

Secondary ID(s)

20060203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors