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

• ClinicalTrials.gov Identifier: NCT00714116
• Recruitment Status: Completed
• First Posted: July 14, 2008
• Last Update Posted: December 7, 2018
• Sponsor: Pfizer
• Collaborator: Emergent Product Development Seattle LLC
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: July 8, 2008
• First Posted Date: July 14, 2008
• Last Update Posted Date: December 7, 2018
• Actual Study Start Date: March 2009
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 27, 2010): 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 ]
• Original Primary Outcome Measures (submitted: July 8, 2008): 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 ]
• Change History: Complete list of historical versions of study NCT00714116 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: September 27, 2010): Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) [ Time Frame: 12 months ]
• Original Secondary Outcome Measures (submitted: July 8, 2008): Initial PK and PD profiles of SBI-087 in subjects with SLE [ Time Frame: 12 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lupus Erythematosus, Systemic

Intervention

Drug: SBI-087

Single IV or SC dose of SBI-087

Study Arms

Experimental: SBI-087

Intervention: Drug: SBI-087

• Publications *: Cohen S, Clowse M, Pardo P, Bhattacharya I, Menon S, Gourley I, Diehl A. Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of SBI-087, a CD20-Directed B-cell Depleting Agent: Phase 1 Dose Escalating Studies in Patients With Either Mild Rheumatoid Arthritis or Systemic Lupus. Clin Ther. 2016 Jun;38(6):1417-1434.e2. doi: 10.1016/j.clinthera.2016.03.028. Epub 2016 Apr 21.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 27, 2010): 30
• Original Estimated Enrollment (submitted: July 8, 2008): 24
• Actual Study Completion Date: September 2012
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Canada

Administrative Information

• NCT Number: NCT00714116
• Other Study ID Numbers: 3227K2-1002; B2261004 ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Emergent Product Development Seattle LLC

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2018