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

Phase 1

Completed

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Drug: SBI-087

• Registration Number: NCT00714116
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-14
• Study Start: 2009-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-05
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SBI-087	SBI-087	-

Primary Outcome Measures

Name	Time	Method
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)	12 months

Secondary Outcome Measures

Name	Time	Method
Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE)	12 months

Trial Locations

Locations (6)

Arthritis & Rheumatology Care Center; 🇺🇸 South Miami, Florida, United States

MRA Clinical Research; 🇺🇸 South Miami, Florida, United States

Miami Research Associates; 🇺🇸 South Miami, Florida, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States