NCT00774943

Brief Summary

This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

Typical duration for phase_1

Geographic Reach
2 countries

12 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

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

3.4 years

First QC Date

October 16, 2008

Last Update Submit

April 5, 2013

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosusICOSLB7RP-1Costimulation

Outcome Measures

Primary Outcomes (1)

  • Subject incidence of treatment-emergent adverse events and the incidence of antibodies to AMG 557.

    Throughout study period

Secondary Outcomes (1)

  • Serum PK profile of AMG 557 after multiple dose administrations. Biomarkers of pharmacodynamic activity for AMG 557.

    Throughout study period

Study Arms (2)

AMG 557

ACTIVE COMPARATOR
Drug: AMG 557

Placebo

PLACEBO COMPARATOR
Drug: AMG 557

Interventions

AMG 557DRUG

A total of 4 cohorts will be administered multiple doses of drug or placebo subcutaneously. Dose escalation will take place by cohort.

AMG 557Placebo

Eligibility Criteria

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

You may qualify if:

  • Before any study-specific procedure, the appropriate written informed consent must be obtained;
  • Men and women, between the ages of 18 and 70 years old, inclusive, at the time of randomization;
  • Diagnosis of SLE as defined by the most recent ACR criteria, including a positive ANA at screening or documented positive ANA (the titer should be at least 1:80) in the past.
  • SLE duration of at least six months, as diagnosed by a physician;
  • Stable disease, defined as no change in SLE therapy within the previous 30 days; and, in the opinion of the investigator, no anticipated need for a change in SLE therapy will be required while the subject is enrolled in the study;
  • Normal or clinically acceptable ECG (12-lead reporting ventricular rate and PR, QRS, QT, QTc) at screening and Day -1 based on the opinion of the investigator;
  • Body mass index from 18 to 40 kg/m2 at screening;
  • Able and willing to complete entire study according to study schedule.
  • Immunizations up to date, with a minimum of tetanus, diphtheria, pertussis (td/Tdap), pneumococcal (polysaccharide) and influenza (during flu season) vaccinations, as determined by the Principal Investigator.

You may not qualify if:

  • Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA);
  • Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization;
  • Evidence of active or latent tuberculosis as assessed by PPD or Quantiferon testing at screening;
  • Have donated blood or experienced a loss of blood \>500mL within 4 weeks of randomization;
  • History of ethanol or drug abuse within the last one year prior to randomization;
  • Evidence of significant renal insufficiency, defined by:
  • The glomerular fitration rate \< 50 mL/min using the Cockroft and Gault equation;
  • Evidence of liver disease (eg, serum ALT or AST \> 2x upper limit of normal);
  • Total WBC \<3000 x 106/L;
  • Neutrophil count \< 1500 x106/L
  • Platelet count \<75,000 x 106/L
  • Hemoglobin \<10g/dL
  • Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would, by it progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures in the medical judgment of the investigator. This includes any age related co-morbidites such as presence of congestive heart failure, angina, chronic obstructive pulmonary disease, asthma, and malignancies (other than resected squamous and basal cell carcinoma of the skin).
  • Presence or history of vasculitis (comprising internal organs or extremities or leading to peripheral neuropathy) within the last 3 years, presence or history of active CNS lupus (defined as seizure disorder, cerebral vascular accident, psychosis ascribed to SLE , encephalitis, meningitis, and myelitis) requiring therapy within the last 3 years;
  • Uncontrolled hypertension (Blood pressure \> 150/95);
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Phoenix, Arizona, 85013, United States

Location

Research Site

San Leandro, California, 94578, United States

Location

Research Site

Danbury, Connecticut, 06810, United States

Location

Research Site

Miami, Florida, 33143, United States

Location

Research Site

Michigan City, Indiana, 46360, United States

Location

Research Site

Manhasset, New York, 11030, United States

Location

Research Site

Rochester, New York, 14642, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Research Site

Amarillo, Texas, 79124, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Research Site

Newmarket, Ontario, L3Y 3R7, Canada

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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

December 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

CA(1)US(11)