NCT02391259

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

4.8 years

First QC Date

January 6, 2015

Last Update Submit

March 27, 2015

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs

    From 29 days to 169 days

Secondary Outcomes (1)

  • Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax

    From 29 days to 169 days

Study Arms (2)

AMG 557

EXPERIMENTAL

AMG 557 administered as subcutaneous and intravenous doses.

Drug: AMG 557

Placebo

PLACEBO COMPARATOR

No active drug

Drug: Placebo

Interventions

AMG 557DRUG

AMG 557 is for the treatment of sybjects with systemic lupus erythematosus

AMG 557
PlaceboDRUG

contains no active drug

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Phoenix, Arizona, 85013, United States

Location

Research Site

Los Angeles, California, 90033, United States

Location

Research Site

Los Angeles, California, 90048, United States

Location

Research Site

Michigan City, Indiana, 46360, United States

Location

Research Site

North Dartmouth, Massachusetts, 02747, United States

Location

Research Site

Manhasset, New York, 11030, United States

Location

Research Site

New York, New York, 10003, United States

Location

Research Site

Rochester, New York, 14642, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Research Site

Dallas, Texas, 75247, United States

Location

Research Site

London, NW10 7NS, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 27099766DERIVED

  • 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.

    PMID: 26138472DERIVED

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

AMG 557

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

March 18, 2015

Study Start

November 1, 2006

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

US(12)GB(1)