Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: RSLV-132

• Registration Number: NCT02194400
• Lead Sponsor: Resolve Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-18
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Stable SLE with no anticipated change in medications for the next 60 days

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Exclusion Criteria

• Other biologic drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSLV-132	RSLV-132	0.3 - 10 mg/kg experimental drug
Placebo	RSLV-132	Saline infusion

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	30 days

Trial Locations

Locations (4)

West Michigan Rheumatology; 🇺🇸 Grand Rapids, Michigan, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Clinical Research of West Florida; 🇺🇸 Clearwater, Florida, United States

Metroplex Clinical Research; 🇺🇸 Dallas, Texas, United States