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

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ClinicalTrials.gov Identifier: NCT02660944
Recruitment Status : Active, not recruiting
First Posted : January 21, 2016
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: RSLV-132 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: RSLV-132
10 mg/kg RSLV-132
Drug: RSLV-132
RNase-Fc fusion protein

Placebo Comparator: Placebo
Saline placebo
Drug: Placebo
Saline placebo




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

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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660944


Locations
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United States, California
TriWest Research Associates
El Cajon, California, United States, 92020
University of California San Diego
La Jolla, California, United States, 92093
Valerius Research Center
Los Alamitos, California, United States, 90720
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States, 33309
Alper Research
Naples, Florida, United States, 34102
United States, New York
Northwell Health/ Division of Rheumatology
Great Neck, New York, United States, 11042
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
United States, North Carolina
DJL Clinical Research
Charlotte, North Carolina, United States, 28210
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Accurate Clinical Research
Sugar Land, Texas, United States, 77479
Sponsors and Collaborators
Resolve Therapeutics
Investigators
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Study Chair: James Posada, Ph.D. Resolve Therapeutics

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Responsible Party: Resolve Therapeutics
ClinicalTrials.gov Identifier: NCT02660944     History of Changes
Other Study ID Numbers: 132-03
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs