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

• ClinicalTrials.gov Identifier: NCT02660944
• Recruitment Status: Active, not recruiting
• First Posted: January 21, 2016
• Last Update Posted: July 23, 2019
• Sponsor: Resolve Therapeutics
• 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

• 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)
• Study Start Date: January 2016
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: January 2020

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 :

1. Proportion of RSLV-132 treated subjects with cutaneous lupus erythematosus disease area and severity index (CLASI) improvement compared to placebo. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. Proportion of RSLV-132 treated subjects with steroid reduction as compared to placebo. [ Time Frame: 24 weeks ]
2. Proportion of RSLV-132 treated subjects with improvement in FACIT-fatigue index as compared to placebo. [ Time Frame: 24 weeks ]

Eligibility Criteria

• 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:

1. severe, active central nervous system (CNS) involvement at Screening;
2. severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol, or an estimated creatinine clearance of <30 mL/min);
3. use of cyclophosphamide within 3 months of the Baseline visit;
4. use of rituximab within 6 months of the Baseline visit;
5. use of belimumab within 3 months of the Baseline visit;
6. 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;
7. use of an intravenous steroid "pulse" within 2 months of Baseline;
8. use of an intramuscular steroid injection within 1 month of Baseline;
9. change in SLE medications within 1 month of Baseline;
10. 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;
11. positive viral load test for hepatitis B, C, or HIV at Screening;
12. 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;
13. positive pregnancy test at Screening or at Baseline;
14. female subjects currently breast feeding at Baseline;
15. 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

Locations

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

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

More Information

• Responsible Party: Resolve Therapeutics
• ClinicalTrials.gov Identifier: NCT02660944
• Other Study ID Numbers: 132-03
• First Posted: January 21, 2016
• Last Update Posted: July 23, 2019
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Immunoglobulin G; Immunologic Factors; Physiological Effects of Drugs