NCT03247686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 2, 2021

Completed
Last Updated

April 2, 2021

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

August 3, 2017

Results QC Date

December 1, 2020

Last Update Submit

March 9, 2021

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

  • Blood Cell Gene Expression

    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.

    Day 1 and Day 99

Secondary Outcomes (1)

  • EULAR ESSDAI Total Score.

    Days 1, 29, 57, 85 and 99

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

RSLV-132

ACTIVE COMPARATOR

Experimental drug

Drug: RSLV-132

Interventions

RSLV-132DRUG

RNase Fc fusion protein

RSLV-132
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Use fo hydroxychloroquine within 30 days of baseline
  • Use of cyclophosphamide within 180 days of baseline
  • Use of oral corticosteroids greater than 10 mg/day
  • Known IgG4-related disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals Birmingham

Birmingham, Edgbaston, B16 6TT, United Kingdom

Location

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, Gosforth, NE3 3HD, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32798283DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

RSLV-132

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
James Posada
Organization
Resolve Therapeutics LLC
jp@resolvebio.com
208 727 7010

Study Officials

  • James Posada, Ph.D.

    Resolve Therapeutics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 14, 2017

Study Start

February 1, 2017

Primary Completion

July 15, 2018

Study Completion

August 1, 2019

Last Updated

April 2, 2021

Results First Posted

April 2, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)