A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT02660944

Recruitment Status : Completed

First Posted : January 21, 2016

Results First Posted : March 10, 2021

Last Update Posted : March 10, 2021

Sponsor:

Information provided by (Responsible Party):

Resolve Therapeutics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Systemic Lupus Erythematosus	Drug: RSLV-132 Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	64 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Actual Study Start Date :	January 3, 2016
Actual Primary Completion Date :	May 28, 2020
Actual Study Completion Date :	August 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Systemic lupus erythematosus

MedlinePlus related topics: Lupus

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: RSLV-132 10 mg/kg RSLV-132	Drug: RSLV-132 RNase-Fc fusion protein
Placebo Comparator: Placebo Saline placebo	Drug: Placebo Saline placebo

Outcome Measures

Primary Outcome Measures :

Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo. [ Time Frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169 ]
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.

Secondary Outcome Measures :

Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score [ Time Frame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169 ]
Percentage of participants achieving a 50% improvement in CLASI activity score at Day 85 and Day 169 (LOCF post censoring due to use of exclusionary medications)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660944

Locations

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United States, California
TriWest Research Associates
El Cajon, California, United States, 92020
University of California San Diego
La Jolla, California, United States, 92093
Valerius Research Center
Los Alamitos, California, United States, 90720
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States, 33309
Alper Research
Naples, Florida, United States, 34102
United States, New York
Northwell Health/ Division of Rheumatology
Great Neck, New York, United States, 11042
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
United States, North Carolina
DJL Clinical Research
Charlotte, North Carolina, United States, 28210
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Accurate Clinical Research
Sugar Land, Texas, United States, 77479

Sponsors and Collaborators

Resolve Therapeutics

Investigators

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Study Chair:	James Posada, Ph.D.	Resolve Therapeutics

Study Documents (Full-Text)

Documents provided by Resolve Therapeutics:

Study Protocol [PDF] April 27, 2017

Statistical Analysis Plan [PDF] March 10, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD007478. doi: 10.1002/14651858.CD007478.pub2.

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Responsible Party:	Resolve Therapeutics
ClinicalTrials.gov Identifier:	NCT02660944
Other Study ID Numbers:	132-03
First Posted:	January 21, 2016 Key Record Dates
Results First Posted:	March 10, 2021
Last Update Posted:	March 10, 2021
Last Verified:	March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

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Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases

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