Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus
A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus
1 other identifier
interventional
32
1 country
4
Brief Summary
A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of RSLV-132 in subjects with inactive to mild SLE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
July 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 9, 2015
December 1, 2015
1.3 years
July 16, 2014
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
30 days
Study Arms (2)
Placebo
PLACEBO COMPARATORSaline infusion
RSLV-132
EXPERIMENTAL0.3 - 10 mg/kg experimental drug
Interventions
Eligibility Criteria
You may qualify if:
- Stable SLE with no anticipated change in medications for the next 60 days
You may not qualify if:
- Other biologic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
West Michigan Rheumatology
Grand Rapids, Michigan, 49546, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Metroplex Clinical Research
Dallas, Texas, 75231, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
James Posada, Ph.D.
Resolve Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2014
First Posted
July 18, 2014
Study Start
July 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-12