A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Sponsors
Lead Sponsor
Collaborators
Source
Resolve Therapeutics
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
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.
Overall Status
Completed
Start Date
2017-02-01
Completion Date
2018-08-01
Primary Completion Date
2018-07-15
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
blood cell gene expression |
Day 99 |
Secondary Outcome
Measure |
Time Frame |
|
European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). |
Day 99 |
Enrollment
28
Condition
Intervention
Eligibility
Criteria
Inclusion Criteria:
1. Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for
Primary Sjogren's Syndrome
2. Presence of anti Ro autoantibodies
3. Presence of interferon signature
Exclusion Criteria:
1. Use fo hydroxychloroquine within 30 days of baseline
2. Use of cyclophosphamide within 180 days of baseline
3. Use of oral corticosteroids greater than 10 mg/day
4. Known IgG4-related disease
Gender
All
Minimum Age
18 Years
Maximum Age
70 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
James Posada, Ph.D. |
Study Director |
Resolve Therapeutics |
Location
Facility |
|
University Hospitals Birmingham Birmingham Edgbaston B16 6TT United Kingdom |
|
Newcastle upon Tyne Hospitals Newcastle upon Tyne Gosforth NE3 3HD United Kingdom |
Location Countries
Country
United Kingdom
Verification Date
2018-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Immunoglobulin G
Arm Group
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
Placebo
Arm Group Label
RSLV-132
Arm Group Type
Active Comparator
Description
Experimental drug
Firstreceived Results Date
N/A
Acronym
RSLV-132
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
August 3, 2017
Study First Submitted Qc
August 10, 2017
Study First Posted
August 14, 2017
Last Update Submitted
September 9, 2019
Last Update Submitted Qc
September 9, 2019
Last Update Posted
September 10, 2019
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.