Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjögren's Syndrome: A Randomized Clinical Trial.
James Posada, Saba Valadkhan, Daniel Burge...
https://pubmed.ncbi.nlm.nih.gov/32798283Actively Recruiting
Phase 2
Age: 18Years - 75Years
FEMALE
ID06440525
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Sjögren's Disease With Moderate to Severe Symptom Burden
Led by Resolve Therapeutics · Updated on 2025-07-18
106
Participants Needed
24
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of RSLV-132 in adult females with Primary Sjögren Syndrome (pSS), a condition characterized by symptoms like fatigue, dryness, and pain. This Phase 2 clinical trial aims to determine if RSLV-132 improves these key symptoms, assess its safety, and study immune responses and blood levels of the drug over time. The study compares RSLV-132 to a placebo to understand its impact on symptom relief and safety in participants with moderate to severe symptom burden. Participants receive intravenous infusions of either 10 mg/kg RSLV-132 or a placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155, covering a total of 22 weeks of treatment. This double-blind, randomized study includes regular clinic visits weekly for the first two weeks, then every two weeks until the end of treatment, with a final follow-up visit at Day 211. Each infusion and visit involves monitoring and assessments to track progress and responses. During the study, participants will record their symptoms daily using an electronic device and attend scheduled clinic visits for check-ups, tests, and questionnaires. Researchers will assess fatigue and tiredness, measure drug levels and immune responses in blood samples, and monitor for any adverse events throughout and after treatment. The main outcome focuses on the evaluation of key symptoms of Sjögren's disease, with safety and immune response also closely observed until Day 211.
CONDITIONS
Brief Title
A Study of RSLV-132 in Females With Sjögren's Disease
Who Can Participate
Age: 18Years - 75Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Providing written informed consent
- Weight at least 45 kg
- Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS
- Diagnosis in the last 30 years
- Positive anti-Ro/SSA antibody test
- Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale
- Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures
You will not qualify if you...
- Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments
- Uncontrolled hypothyroidism or severe fibromyalgia
- New medications or change in medications in the last 4 weeks for pSS symptoms
- Receipt of other prohibited medications
- Apheresis or blood donation
- Allergic reaction to RSLV-132 or biologic therapy
- Clinically significant infection in last 30 days
- Participation in another clinical study
- Malignancy in last 5 years
- Positive test for HIV or hepatitis
- Major surgery in last 30 days or anticipated surgery during the study
- Pregnancy or breast feeding
- Laboratory blood tests outside of specified ranges
- Other medical conditions or medications that would make the participant unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 22 weeks
Participants receive intravenous infusions of RSLV-132 or placebo over 22 weeks.
13 infusion visits on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155
Follow-up
Duration - Up to 8 weeks after treatment
Participants are monitored for safety and pharmacokinetics after treatment ends.
Visits for assessments up to Day 211 after the first dose
Trial Site Locations
Total: 24 locations
1
Resolve Clinical Site
Chula Vista, California, United States, 91910
Actively Recruiting
2
Resolve Clinical Site
Tustin, California, United States, 92780
Actively Recruiting
3
Resolve Clinical Site
Boca Raton, Florida, United States, 34994
Actively Recruiting
4
Resolve Clinical Site
Boynton Beach, Florida, United States, 33467
Actively Recruiting
5
Evolution Research Center
Hialeah, Florida, United States, 33024
Actively Recruiting
6
GNP Research
Hollywood, Florida, United States, 33024
Actively Recruiting
7
Resolve Clinical Site
Miami, Florida, United States, 33140
Actively Recruiting
8
Life Medical Research
Miami Gardens, Florida, United States, 33014
Actively Recruiting
9
Resolve Clinical Site
Chicago, Illinois, United States, 60607
Actively Recruiting
10
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
Tufts College
Boston, Massachusetts, United States, 02111-1817
Actively Recruiting
12
Resolve Clinical Site
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
13
Joint and Muscle Research Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
14
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States, 28208
Actively Recruiting
15
Onsite Clinical Solutions
Salisbury, North Carolina, United States, 28277
Actively Recruiting
16
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
17
Resolve Clinical Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
18
Resolve Clinical Site
Austin, Texas, United States, 78757
Actively Recruiting
19
Resolve Clinical Site
Katy, Texas, United States, 77449
Actively Recruiting
20
Resolve Clinical Site
McKinney, Texas, United States, 75069
Actively Recruiting
21
Accurate Clinical Research
Richmond, Texas, United States, 77089
Actively Recruiting
22
Resolve Clinical Site
San Antonio, Texas, United States, 78215
Actively Recruiting
23
Metrodora Institute
Salt Lake City, Utah, United States, 84119
Actively Recruiting
24
Arthritis Northwest
Spokane, Washington, United States, 99204
Actively Recruiting
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Research Team
P
PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts.
Caroline H Shiboski, Stephen C Shiboski, Raphaèle Seror...
https://pubmed.ncbi.nlm.nih.gov/27785888