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

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660944
• Other study ID #: 132-03
• Status: Completed
• Phase: Phase 2
• Start date: January 3, 2016
• Est. completion date: August 10, 2020

Study information

• Verified date: March 2021
• Source: Resolve Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 10, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• RSLV-132
RNase-Fc fusion protein
• Placebo
Saline placebo

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	DJL Clinical Research	Charlotte	North Carolina
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	TriWest Research Associates	El Cajon	California
United States	Center for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	Northwell Health/ Division of Rheumatology	Great Neck	New York
United States	University of California San Diego	La Jolla	California
United States	Valerius Research Center	Los Alamitos	California
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	Feinstein Institute for Medical Research	Manhasset	New York
United States	Alper Research	Naples	Florida
United States	Vanderbilt University	Nashville	Tennessee
United States	Temple University	Philadelphia	Pennsylvania
United States	Accurate Clinical Research	Sugar Land	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Resolve Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score	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)	Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169