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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

Tracking Information
First Submitted Date  ICMJE January 16, 2016
First Posted Date  ICMJE January 21, 2016
Last Update Posted Date July 23, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02660944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: RSLV-132
    RNase-Fc fusion protein
  • Drug: Placebo
    Saline placebo
Study Arms  ICMJE
  • Experimental: RSLV-132
    10 mg/kg RSLV-132
    Intervention: Drug: RSLV-132
  • Placebo Comparator: Placebo
    Saline placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 19, 2019)
64
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2016)
50
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02660944
Other Study ID Numbers  ICMJE 132-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Resolve Therapeutics
Study Sponsor  ICMJE Resolve Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: James Posada, Ph.D. Resolve Therapeutics
PRS Account Resolve Therapeutics
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP