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Completed

NCT Number: NCT02660944

A Phase 2a 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TriWest Research Associates, El Cajon, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RSLV-132

Drug

RNase-Fc fusion protein

Placebo

Drug

Saline placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Resolve Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2016
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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