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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Sponsor:
Resolve Therapeutics
Collaborators:
University Hospital Birmingham
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
Resolve Therapeutics
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Sjogren's Syndrome |
| Interventions |
Drug: RSLV-132 Drug: Placebo |
| Enrollment | 28 |
Participant Flow
| Recruitment Details | Participants were recruited between 12 December 2016 and 01 February 2018. Participants were recruited from the Investigator's medical clinics. |
| Pre-assignment Details | Participants were randomized in a 3:1 ratio to either RSLV-132 or placebo. A total of 22 participants were randomised to RSLV-2 and 8 to placebo. Two participants randomized to RSLV-2 were withdrawn prior to the start of study treatment, one withdrew consent and one was found not to meet the eligibility criteria. |
| Arm/Group Title | Placebo | RSLV-132 |
|---|---|---|
 Arm/Group Description |
Placebo Placebo: Placebo |
Experimental drug RSLV-132: RNase Fc fusion protein |
| Period Title: Overall Study | ||
| Started | 8 | 20 |
| Completed | 7 | 18 |
| Not Completed | 1 | 2 |
| Reason Not Completed | ||
| Withdrawal by Subject | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Placebo | RSLV-132 | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Placebo Placebo: Placebo |
Experimental drug RSLV-132: RNase Fc fusion protein |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 8 | 20 | 28 | |
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Baseline Analysis Population Description |
All participants randomized who received at least one dose of study treatment (RSLV-132 or placebo).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 8 participants | 20 participants | 28 participants | |
| 59.6 (8.8) | 56.5 (12.9) | 57.4 (11.8) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 8 participants | 20 participants | 28 participants | |
| Female |
8 100.0%
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20 100.0%
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28 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 8 participants | 20 participants | 28 participants | |
| Hispanic or Latino |
0 0.0%
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1 5.0%
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1 3.6%
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| Not Hispanic or Latino |
8 100.0%
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19 95.0%
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27 96.4%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 8 participants | 20 participants | 28 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
1 12.5%
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1 5.0%
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2 7.1%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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| White |
7 87.5%
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19 95.0%
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26 92.9%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United Kingdom | Number Analyzed | 8 participants | 20 participants | 28 participants |
| 8 | 20 | 28 | ||
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EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) Total Score
[1] Mean (Standard Deviation) Unit of measure: Scores on a scale |
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| Number Analyzed | 8 participants | 20 participants | 28 participants | |
| 5.1 (4.1) | 5.0 (4.6) | 5.1 (4.4) | ||
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[1]
Measure Description: The ESSDAI is a systemic disease activity index used in clinical studies. It includes 12 domains (i.e, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, hematological, glandular, constitutional, lymphadenopathic, biological) and each domain is divided into 3 or 4 levels of activity (0 - No, 1 - Low, 2 - Moderate, 3 - High). The score from each domain is added to make the total score. The scale total score ranges from 0 to 123. A lower score represents less disease activity.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | James Posada |
| Organization: | Resolve Therapeutics LLC |
| Phone: | 208 727 7010 |
| EMail: | jp@resolvebio.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Resolve Therapeutics |
| ClinicalTrials.gov Identifier: | NCT03247686 |
| Other Study ID Numbers: |
132-04 |
| First Submitted: | August 3, 2017 |
| First Posted: | August 14, 2017 |
| Results First Submitted: | December 1, 2020 |
| Results First Posted: | April 2, 2021 |
| Last Update Posted: | April 2, 2021 |