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

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

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

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Drug: RSLV-132

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Resolve Therapeutics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2016
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): August 10, 2020

Study Registration Dates

• First Submitted: January 16, 2016
• First Submitted That Met QC Criteria: January 16, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 132-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO