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

July 8, 2008
December 20, 2012
February 2009
September 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00714116 on ClinicalTrials.gov Archive Site
Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Initial PK and PD profiles of SBI-087 in subjects with SLE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Systemic Lupus Erythematosus

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lupus Erythematosus, Systemic
Drug: SBI-087
Single IV or SC dose of SBI-087
Experimental: SBI-087
Intervention: Drug: SBI-087
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00714116
3227K2-1002, B2261004
No
Pfizer
Pfizer
Emergent Product Development Seattle LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

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