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A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome (RSLV-132)

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ClinicalTrials.gov Identifier: NCT03247686
Recruitment Status : Completed
First Posted : August 14, 2017
Results First Posted : April 2, 2021
Last Update Posted : April 2, 2021
University Hospital Birmingham
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
Resolve Therapeutics

Tracking Information
First Submitted Date  ICMJE August 3, 2017
First Posted Date  ICMJE August 14, 2017
Results First Submitted Date  ICMJE December 1, 2020
Results First Posted Date  ICMJE April 2, 2021
Last Update Posted Date April 2, 2021
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2021)
Blood Cell Gene Expression [ Time Frame: Day 1 and Day 99 ]
Interferon gene expression (mean log2 fold change from baseline to Day 99). The of expression of three IFN-inducible genes (HERC5, EPSTI1, CMPK2) was measured by qPCR to assess the IFN signature status (the altered pattern of gene expression) of Sjögren's syndrome patients.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
blood cell gene expression [ Time Frame: Day 99 ]
Interferon gene expression
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2021)
EULAR ESSDAI Total Score. [ Time Frame: Days 1, 29, 57, 85 and 99 ]
Clinical disease activity: Change from Baseline to Day 99 in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index Total Scores (imputed values with last observation carried forward). The scale ranges from 0 to 123. A higher score means more disease activity (worse outcome).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). [ Time Frame: Day 99 ]
clinical disease activity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Official Title  ICMJE A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Brief Summary The present study will examine the role of circulating RNA complexed with autoantibodies and immune complexes and its role in activation of inflammatory pathways in patients with primary Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene expression in blood cells. A number of biochemical and clinical parameters will be analyzed to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.
Detailed Description

This is a multi-center, double-blind, placebo-controlled study to evaluate the impact of 8 intravenous infusions of RSLV-132 in 28 patients with primary Sjogren's syndrome. Each of the subjects will be randomized 3:1 (active:placebo) and will receive 8 infusions of 10 mg/kg of RSLV-132 or placebo as follows on days:

• 1, 8, 15, 29, 43, 57, 71, and 85

Potential subjects will be screened to assess their eligibility to enter the study within 60 days prior to study entry (i.e., prior to Baseline visit). Following Baseline evaluations on Day 1, subjects will receive their first infusion of RSLV-132 or placebo. Subjects will return to the research unit for follow-up visits as described in Appendix A.

Dose selection rationale: The dose level was chosen based on safety and tolerability data from Protocol 132-02 (multiple ascending dose study in SLE patients). Additionally, in a 6-month toxicology study in cynomolgus monkeys, 50 mg/kg of RSLV-132 was administered by IV infusion weekly. No dose-limiting toxicity was noted, therefore the No Observed Adverse Effect Level is at least 50 mg/kg, providing at least a 5-fold safety margin for this study.

RSLV-132 shall be prepared for each subject from individual stock vials provided by Sponsor. Details of dilution, dose preparation, and administration instructions will be provided in the Study Drug Reference Guide. The dose for each individual shall be based on the subject's body weight.

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 Sjogren's Syndrome
Intervention  ICMJE
  • Drug: RSLV-132
    RNase Fc fusion protein
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: RSLV-132
    Experimental drug
    Intervention: Drug: RSLV-132
Publications * Posada J, Valadkhan S, Burge D, Davies K, Tarn J, Casement J, Jobling K, Gallagher P, Wilson D, Barone F, Fisher BA, Ng WF. Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjogren's Syndrome: A Randomized Clinical Trial. Arthritis Rheumatol. 2021 Jan;73(1):143-150. doi: 10.1002/art.41489. Epub 2020 Nov 22.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2019
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for Primary Sjogren's Syndrome
  2. Presence of anti Ro autoantibodies
  3. Presence of interferon signature

Exclusion Criteria:

  1. Use fo hydroxychloroquine within 30 days of baseline
  2. Use of cyclophosphamide within 180 days of baseline
  3. Use of oral corticosteroids greater than 10 mg/day
  4. Known IgG4-related disease
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 Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03247686
Other Study ID Numbers  ICMJE 132-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Resolve Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Resolve Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University Hospital Birmingham
  • Newcastle-upon-Tyne Hospitals NHS Trust
Investigators  ICMJE
Study Director: James Posada, Ph.D. Resolve Therapeutics
PRS Account Resolve Therapeutics
Verification Date October 2020

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