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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research of West Florida, Clearwater, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Other biologic drugs

Treatment and study plan

RSLV-132

Biological

0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks

Primary outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Resolve Therapeutics

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jul 18, 2014
Registry last updated: Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed