Brief Summary

This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2016

Typical duration for phase_2

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.6 years study duration

Study Start

First participant enrolled

January 3, 2016

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed

7 months until next milestone

Results Posted

Study results publicly available

March 10, 2021

Completed

Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

4.4 years

First QC Date

January 16, 2016

Results QC Date

December 1, 2020

Last Update Submit

March 9, 2021

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward \[LOCF\] post censoring values). The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169

Secondary Outcomes (1)

Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169

Study Arms (2)

RSLV-132

EXPERIMENTAL

10 mg/kg RSLV-132

Drug: RSLV-132

Placebo

PLACEBO COMPARATOR

Saline placebo

Drug: Placebo

Interventions

RSLV-132DRUG

RNase-Fc fusion protein

RSLV-132

PlaceboDRUG

Saline placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

CLASI score greater than or equal to 10 at Baseline
Positive for one or more RNA autoantibodies

You may not qualify if:

severe, active central nervous system (CNS) involvement at Screening;
severe renal involvement at Screening (urine protein/creatinine ratio of \>200 mg/mmol, or an estimated creatinine clearance of \<30 mL/min);
use of cyclophosphamide within 3 months of the Baseline visit;
use of rituximab within 6 months of the Baseline visit;
use of belimumab within 3 months of the Baseline visit;
use of background medications within 1 month of Baseline in excess of: i. mycophenolate mofetil \> 3 g/day; ii. azathioprine \> 200 mg/day; iii. methotrexate \> 25 mg/day; iv. hydroxychloroquine \> 400 mg/day; v. prednisone (or equivalent) \> 15 mg/day;
use of an intravenous steroid "pulse" within 2 months of Baseline;
use of an intramuscular steroid injection within 1 month of Baseline;
change in SLE medications within 1 month of Baseline;
the presence of a clinically significant infection in the judgement of the Investigator within seven days prior to the receipt of the first dose of study drug;
positive viral load test for hepatitis B, C, or HIV at Screening;
participation in another clinical trial with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline;
positive pregnancy test at Screening or at Baseline;
female subjects currently breast feeding at Baseline;
inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Resolve Therapeuticslead

Study Sites (16)

TriWest Research Associates

El Cajon, California, 92020, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Valerius Research Center

Los Alamitos, California, 90720, United States

Location

Wallace Rheumatic Study Center

Los Angeles, California, 90048, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Center for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

Alper Research

Naples, Florida, 34102, United States

Location

Northwell Health/ Division of Rheumatology

Great Neck, New York, 11042, United States

Location

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Accurate Clinical Research

Sugar Land, Texas, 77479, United States

Location

Related Publications (1)

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PMID: 33687069DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

RSLV-132

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title: James Posada
Organization: Resolve Therapeutics LLC

Study Officials

James Posada, Ph.D.
Resolve Therapeutics
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 16, 2016

First Posted

January 21, 2016

Study Start

January 3, 2016

Primary Completion

May 28, 2020

Study Completion

August 10, 2020

Last Updated

March 10, 2021

Results First Posted

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing: Will not share

Locations

US(16)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

RSLV-132

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations