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

NCT ID: NCT02194400

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Systemic Lupus Erythematosus

Keywords

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RSLV-132 Systemic Lupus Erythematosus Lupus SLE Resolve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Saline infusion

Group Type PLACEBO_COMPARATOR

RSLV-132

Intervention Type BIOLOGICAL

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

RSLV-132

0.3 - 10 mg/kg experimental drug

Group Type EXPERIMENTAL

RSLV-132

Intervention Type BIOLOGICAL

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

Interventions

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RSLV-132

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Other biologic drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Resolve Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Posada, Ph.D.

Role: STUDY_CHAIR

Resolve Therapeutics

Locations

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Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

West Michigan Rheumatology

Grand Rapids, Michigan, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Metroplex Clinical Research

Dallas, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.resolvebio.com

Resolve Therapeutics Website

http://www.lupustrials.org

Lupus Research Institute

Other Identifiers

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132-02

Identifier Type: -

Identifier Source: org_study_id