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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02194400

Enrollment

Registered

2014-07-18

Start date

2014-07-31

Completion date

2015-11-30

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

RSLV-132, Systemic Lupus Erythematosus, Lupus, SLE, Resolve

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.

Interventions

BIOLOGICALRSLV-132

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Other biologic drugs

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026