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

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: RSLV-132

• Registration Number: NCT02660944
• Lead Sponsor: Resolve Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-03
• Study First Submitted: 2016-01-16
• Study First Submitted QC: 2016-01-16
• Study First Posted: 2016-01-21
• Primary Completion: 2020-05-28
• Study Completion: 2020-08-10
• Results First Submitted: 2020-12-01
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Results First Posted: 2021-03-10
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline placebo
RSLV-132	RSLV-132	10 mg/kg RSLV-132

Primary Outcome Measures

Name	Time	Method
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.	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

Name	Time	Method
Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score	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)

Trial Locations

Locations (16)

Feinstein Institute for Medical Research; 🇺🇸 Manhasset, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Wallace Rheumatic Study Center; 🇺🇸 Los Angeles, California, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

TriWest Research Associates; 🇺🇸 El Cajon, California, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Valerius Research Center; 🇺🇸 Los Alamitos, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Clinical Research of West Florida; 🇺🇸 Clearwater, Florida, United States

Center for Rheumatology, Immunology and Arthritis; 🇺🇸 Fort Lauderdale, Florida, United States

Alper Research; 🇺🇸 Naples, Florida, United States

Northwell Health/ Division of Rheumatology; 🇺🇸 Great Neck, New York, United States

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States

Accurate Clinical Research; 🇺🇸 Sugar Land, Texas, United States

DJL Clinical Research; 🇺🇸 Charlotte, North Carolina, United States