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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Mar 2009

Typical duration for phase_1

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

First Submitted

Initial submission to the registry

July 8, 2008

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed

8 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed

Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

3.5 years

First QC Date

July 8, 2008

Last Update Submit

December 5, 2018

Conditions

Lupus Erythematosus, Systemic

Keywords

safetypharmacokinetics

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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

Study Arms (1)

SBI-087

EXPERIMENTAL

Drug: SBI-087

Interventions

SBI-087DRUG

Single IV or SC dose of SBI-087

SBI-087

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead
Emergent Product Development Seattle LLCcollaborator

Study Sites (6)

Arthritis & Rheumatology Care Center

South Miami, Florida, 33143, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

MRA Clinical Research

South Miami, Florida, 33143, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Related Publications (1)

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.
PMID: 27112532DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

SBI-087

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

March 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 7, 2018

Record last verified: 2018-12

Locations

US(6)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

SBI-087

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

SBI-087

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations