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

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RSLV-132

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring RSLV-132, Systemic Lupus Erythematosus, Lupus, SLE, Resolve

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Other biologic drugs

Sites / Locations

Clinical Research of West Florida
West Michigan Rheumatology
Altoona Center for Clinical Research
Metroplex Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

RSLV-132

Arm Description

Saline infusion

0.3 - 10 mg/kg experimental drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02194400

First Posted

July 16, 2014

Last Updated

December 8, 2015

Sponsor

Resolve Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02194400

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Resolve Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline infusion

Arm Title

RSLV-132

Arm Type

Experimental

Arm Description

0.3 - 10 mg/kg experimental drug

Intervention Type

Biological

Intervention Name(s)

RSLV-132

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stable SLE with no anticipated change in medications for the next 60 days Exclusion Criteria: Other biologic drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Posada, Ph.D.

Organizational Affiliation

Resolve Therapeutics

Official's Role

Study Chair

Facility Information:

Facility Name

Clinical Research of West Florida

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

West Michigan Rheumatology

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Metroplex Clinical Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.resolvebio.com

Description

Resolve Therapeutics Website

URL

http://www.lupustrials.org

Description

Lupus Research Institute

Learn more about this trial

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

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