Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

This study has been completed.

Sponsor:

Collaborator:

Emergent Product Development Seattle LLC

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00714116

First received: July 8, 2008

Last updated: December 20, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2008

Last Updated Date

December 20, 2012

Start Date ^ICMJE

February 2009

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with SLE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00714116 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Initial PK and PD profiles of SBI-087 in subjects with SLE [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

Official Title ^ICMJE

An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Systemic Lupus Erythematosus

Brief Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lupus Erythematosus, Systemic

Intervention ^ICMJE

Drug: SBI-087

Single IV or SC dose of SBI-087

Study Arm (s)

Experimental: SBI-087

Intervention: Drug: SBI-087

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology [ACR] Revised Criteria) greater than 6 months before study day 1.
History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.

Exclusion Criteria:

Treatment with more than 20 mg of prednisone per day.
Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE.
History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00714116

Other Study ID Numbers ^ICMJE

3227K2-1002, B2261004

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Emergent Product Development Seattle LLC

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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