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

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

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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: RSLV-132
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSLV-132<br>10 mg/kg RSLV-132 | Drug: RSLV-132<br>* RNase-Fc fusion protein<br>|
| Placebo Comparator: Placebo<br>Saline placebo | Drug: Placebo<br>* Saline placebo<br>|

What is the study measuring?
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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 |