Clinical trial NCT02660944: A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Official title: A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Resolve Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-01-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
timeFrame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
Secondary outcomes:
measure: Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
timeFrame: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
Other outcomes:
Locations:
city: El Cajon
country: United States
facility: TriWest Research Associates
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Alamitos
country: United States
facility: Valerius Research Center
state: California
city: Los Angeles
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology, Immunology and Arthritis
state: Florida
city: Naples
country: United States
facility: Alper Research
state: Florida
city: Great Neck
country: United States
facility: Northwell Health/ Division of Rheumatology
state: New York
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Sugar Land
country: United States
facility: Accurate Clinical Research
state: Texas
Study officials:
affiliation: Resolve Therapeutics
name: James Posada, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.