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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03247686
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
University Hospital Birmingham
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
Resolve Therapeutics

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.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Drug: RSLV-132 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

Active Comparator: RSLV-132
Experimental drug
Drug: RSLV-132
RNase Fc fusion protein




Primary Outcome Measures :
  1. blood cell gene expression [ Time Frame: Day 99 ]
    Interferon gene expression


Secondary Outcome Measures :
  1. European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). [ Time Frame: Day 99 ]
    clinical disease activity



Information from the National Library of Medicine

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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:

  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

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): NCT03247686


Locations
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United Kingdom
University Hospitals Birmingham
Birmingham, Edgbaston, United Kingdom, B16 6TT
Newcastle upon Tyne Hospitals
Newcastle upon Tyne, Gosforth, United Kingdom, NE3 3HD
Sponsors and Collaborators
Resolve Therapeutics
University Hospital Birmingham
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
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Study Director: James Posada, Ph.D. Resolve Therapeutics

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Responsible Party: Resolve Therapeutics
ClinicalTrials.gov Identifier: NCT03247686    
Other Study ID Numbers: 132-04
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs