Phase 2 N=28 Randomized Quadruple-blind Treatment

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

Sjogren's Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03247686 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Apr 2021

Primary outcome: Primary: Blood Cell Gene Expression — -0.0291486; 0.1330903; 0.2509076; 0.06726222 log 2 fold change — p=0.0000496

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: RSLV-132 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Resolve Therapeutics
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Cell Gene Expression	-0.0291486; 0.1330903; 0.2509076; 0.06726222; -0.0301788; 0.08489987	0.0000496 sig
SECONDARY EULAR ESSDAI Total Score.	-2.5; 0.0	0.180

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03247686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.