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

Primary Purpose

Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SBI-087
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring safety, pharmacokinetics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arthritis & Rheumatology Care Center
  • Miami Research Associates
  • MRA Clinical Research
  • Duke University Medical Center
  • Altoona Center for Clinical Research
  • Metroplex Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBI-087

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE)

Full Information

First Posted
July 8, 2008
Last Updated
December 5, 2018
Sponsor
Pfizer
Collaborators
Emergent Product Development Seattle LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00714116
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (Actual)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Emergent Product Development Seattle LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
safety, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBI-087
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SBI-087
Intervention Description
Single IV or SC dose of SBI-087
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Arthritis & Rheumatology Care Center
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
MRA Clinical Research
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27112532
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3227K2-1002&StudyName=Study%20Evaluating%20The%20SBI-087%20In%20Subjects%20with%20Systemic%20Lupus%20Erythematosus
Description
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Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

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