A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome (RSLV-132)
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| ClinicalTrials.gov Identifier: NCT03247686 |
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Recruitment Status :
Completed
First Posted : August 14, 2017
Results First Posted : April 2, 2021
Last Update Posted : April 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sjogren's Syndrome | Drug: RSLV-132 Drug: Placebo | Phase 2 |
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 : | 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, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo
Placebo |
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Active Comparator: RSLV-132
Experimental drug
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Drug: RSLV-132
RNase Fc fusion protein |
- 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.
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| United Kingdom | |
| University Hospitals Birmingham | |
| Birmingham, Edgbaston, United Kingdom, B16 6TT | |
| Newcastle upon Tyne Hospitals | |
| Newcastle upon Tyne, Gosforth, United Kingdom, NE3 3HD | |
| Study Director: | James Posada, Ph.D. | Resolve Therapeutics |
Documents provided by Resolve Therapeutics:
| Responsible Party: | Resolve Therapeutics |
| ClinicalTrials.gov Identifier: | NCT03247686 |
| Other Study ID Numbers: |
132-04 |
| First Posted: | August 14, 2017 Key Record Dates |
| Results First Posted: | April 2, 2021 |
| Last Update Posted: | April 2, 2021 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |