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A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

AMG 623

Placebo

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMG 623

Placebo

Arm Description

Single dose of AMG 623 administered as subcutaneous and intravenous doses

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

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events

Incidence of abnormal clinically significant vital signs

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

Incidence of abnormal clinically significant ECG results

Secondary Outcome Measures

Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax

Full Information

NCT ID

NCT02443506

First Posted

May 11, 2015

Last Updated

May 13, 2015

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02443506

Brief Title

A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

Official Title

A Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus Erythematosus

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMG 623

Arm Type

Experimental

Arm Description

Single dose of AMG 623 administered as subcutaneous and intravenous doses

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AMG 623

Intervention Description

Single dose of AMG 623 administered as subcutaneous and intravenous doses

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of treatment emergent adverse events

Time Frame

up to 70 days

Title

Incidence of abnormal clinically significant vital signs

Time Frame

up to 70 days

Title

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

Time Frame

up to 70 days

Title

Incidence of abnormal clinically significant ECG results

Time Frame

up to 70 days

Secondary Outcome Measure Information:

Title

Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax

Time Frame

up to 70 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

26290435

Citation

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.

Results Reference

derived

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

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