NCT02443506

Brief Summary

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2004

Typical duration for phase_1

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

October 1, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
Last Updated

May 14, 2015

Status Verified

April 1, 2015

Enrollment Period

2.5 years

First QC Date

May 11, 2015

Last Update Submit

May 13, 2015

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (4)

  • Incidence of treatment emergent adverse events

    up to 70 days

  • Incidence of abnormal clinically significant vital signs

    up to 70 days

  • Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results

    up to 70 days

  • Incidence of abnormal clinically significant ECG results

    up to 70 days

Secondary Outcomes (1)

  • Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax

    up to 70 days

Study Arms (2)

AMG 623

EXPERIMENTAL

Single dose of AMG 623 administered as subcutaneous and intravenous doses

Drug: AMG 623

Placebo

PLACEBO COMPARATOR

Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Drug: Placebo

Interventions

AMG 623DRUG

Single dose of AMG 623 administered as subcutaneous and intravenous doses

AMG 623
PlaceboDRUG

Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women, between the ages of 18 and 55
  • Diagnosis of SLE
  • Have had a disease duration of at least 1 year, as diagnosed by a physician

You may not qualify if:

  • Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion
  • Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection
  • Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment
  • Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Stohl W, Merrill JT, Looney RJ, Buyon J, Wallace DJ, Weisman MH, Ginzler EM, Cooke B, Holloway D, Kaliyaperumal A, Kuchimanchi KR, Cheah TC, Rasmussen E, Ferbas J, Belouski SS, Tsuji W, Zack DJ. Treatment of systemic lupus erythematosus patients with the BAFF antagonist "peptibody" blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials. Arthritis Res Ther. 2015 Aug 20;17(1):215. doi: 10.1186/s13075-015-0741-z.

    PMID: 26290435DERIVED

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 14, 2015

Study Start

October 1, 2004

Primary Completion

April 1, 2007

Study Completion

June 1, 2007

Last Updated

May 14, 2015

Record last verified: 2015-04