Clinical trial NCT02391259: A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
Official title: Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts


Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE with positive ANA
* Stable disease with no change in SLE therapy within the previous 30 days
* BMI from 18 to 38 kg/m2

Exclusion Criteria:

* Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
* Evidence of renal disease or liver disease
* Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
* Prior administration of any other biologic that primarily targets the immune system

Primary outcomes:
measure: Safety and tolerability
timeFrame: From 29 days to 169 days
Secondary outcomes:
measure: Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax
timeFrame: From 29 days to 169 days
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Michigan City
country: United States
facility: Research Site
state: Indiana
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Manhasset
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Sullivan BA, Tsuji W, Kivitz A, Peng J, Arnold GE, Boedigheimer MJ, Chiu K, Green CL, Kaliyaperumal A, Wang C, Ferbas J, Chung JB. Inducible T-cell co-stimulator ligand (ICOSL) blockade leads to selective inhibition of anti-KLH IgG responses in subjects with systemic lupus erythematosus. Lupus Sci Med. 2016 Apr 8;3(1):e000146. doi: 10.1136/lupus-2016-000146. eCollection 2016.
citation: Welcher AA, Boedigheimer M, Kivitz AJ, Amoura Z, Buyon J, Rudinskaya A, Latinis K, Chiu K, Oliner KS, Damore MA, Arnold GE, Sohn W, Chirmule N, Goyal L, Banfield C, Chung JB. Blockade of interferon-gamma normalizes interferon-regulated gene expression and serum CXCL10 levels in patients with systemic lupus erythematosus. Arthritis Rheumatol. 2015 Oct;67(10):2713-22. doi: 10.1002/art.39248.