- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03247686
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome (RSLV-132)
A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Edgbaston
-
Birmingham, Edgbaston, United Kingdom, B16 6TT
- University Hospitals Birmingham
-
-
Gosforth
-
Newcastle upon Tyne, Gosforth, United Kingdom, NE3 3HD
- Newcastle upon Tyne Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
|
Active Comparator: RSLV-132
Experimental drug
|
RNase Fc fusion protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1 and Day 99
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Days 1, 29, 57, 85 and 99
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: James Posada, Ph.D., Resolve Therapeutics
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Syndrome
- Sjogren's Syndrome
Other Study ID Numbers
- 132-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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