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

• ClinicalTrials.gov Identifier: NCT02660944
• Recruitment Status: Completed
• First Posted: January 21, 2016
• Results First Posted: March 10, 2021
• Last Update Posted: March 10, 2021
• Sponsor: Resolve Therapeutics
• Information provided by (Responsible Party): Resolve Therapeutics

Tracking Information

• First Submitted Date: January 16, 2016
• First Posted Date: January 21, 2016
• Results First Submitted Date: December 1, 2020
• Results First Posted Date: March 10, 2021
• Last Update Posted Date: March 10, 2021
• Actual Study Start Date: January 3, 2016
• Actual Primary Completion Date: May 28, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 9, 2021)

Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo. [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: January 16, 2016): Proportion of RSLV-132 treated subjects with cutaneous lupus erythematosus disease area and severity index (CLASI) improvement compared to placebo. [ Time Frame: 24 weeks ]

Current Secondary Outcome Measures (submitted: March 9, 2021)

Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score [ Time Frame: 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)

Original Secondary Outcome Measures (submitted: January 16, 2016)

• Proportion of RSLV-132 treated subjects with steroid reduction as compared to placebo. [ Time Frame: 24 weeks ]
• Proportion of RSLV-132 treated subjects with improvement in FACIT-fatigue index as compared to placebo. [ Time Frame: 24 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Systemic Lupus Erythematosus

Intervention

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

Study Arms

• Experimental: RSLV-132
  10 mg/kg RSLV-132
  Intervention: Drug: RSLV-132
• Placebo Comparator: Placebo
  Saline placebo
  Intervention: Drug: Placebo

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 19, 2019): 64
• Original Estimated Enrollment (submitted: January 16, 2016): 50
• Actual Study Completion Date: August 10, 2020
• Actual Primary Completion Date: May 28, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02660944
• Other Study ID Numbers: 132-03
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Resolve Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Resolve Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: James Posada, Ph.D.; Resolve Therapeutics

• PRS Account: Resolve Therapeutics
• Verification Date: March 2021