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NCT02194400 Clinical Trial

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

Systemic Lupus Erythematosus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02194400
Other study ID # 132-02
Secondary ID
Status Completed
Phase Phase 1
First received July 16, 2014
Last updated December 8, 2015
Start date July 2014
Est. completion date November 2015

Study information
Verified date December 2015
Source Resolve Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Other biologic drugs

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Clinical Research of West Florida Clearwater Florida
United States Metroplex Clinical Research Dallas Texas
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States West Michigan Rheumatology Grand Rapids Michigan

Sponsors (1)
Lead Sponsor Collaborator
Resolve Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 30 days No
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