Primary Sjögren SyndromePhase 2NCT06440525
A Study of RSLV-132 in Females With Sjögren's Disease
A Phase 2 study testing RSLV-132 in people with Primary Sjögren Syndrome, run by Resolve Therapeutics at 24 sites in United States.
Trial summary
The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are: Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain? Does RSLV-132 improve the… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Primary Sjögren Syndrome
- What is being tested?
- RSLV-132
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 24 sitesUnited States
- Study dates
- 1 Dec 2024to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Resolve Clinical Site
Albuquerque, New Mexico, 87106
Resolve Clinical Site
Austin, Texas, 78757
Resolve Clinical Site
Boca Raton, Florida, 34994
Tufts College
Boston, Massachusetts, 02111-1817
Resolve Clinical Site
Boynton Beach, Florida, 33467
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28208
Resolve Clinical Site
Chicago, Illinois, 60607
Resolve Clinical Site
Chula Vista, California, 91910
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Evolution Research Center
Hialeah, Florida, 33024
GNP Research
Hollywood, Florida, 33024
University of Iowa
Iowa City, Iowa, 52242
Resolve Clinical Site
Katy, Texas, 77449
Resolve Clinical Site
McKinney, Texas, 75069
Resolve Clinical Site
Miami, Florida, 33140
Life Medical Research
Miami Gardens, Florida, 33014
Resolve Clinical Site
Nashville, Tennessee, 37203
Accurate Clinical Research
Richmond, Texas, 77089
Onsite Clinical Solutions
Salisbury, North Carolina, 28277
Metrodora Institute
Salt Lake City, Utah, 84119
Resolve Clinical Site
San Antonio, Texas, 78215
Arthritis Northwest
Spokane, Washington, 99204
Resolve Clinical Site
Tustin, California, 92780
About this study
Official title: 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
The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are:
- Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain?
- Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's?
- What are the blood levels of RSLV-132 over time?
- What is the immune (antibody) response in the body to RSLV-132?
- What is the safety profile of RSLV-132?
Read more
Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS.
Participants will:
Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device
- Conditions
- Primary Sjögren Syndrome
- Being tested
- RSLV-132, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSLV-132Drug
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
PlaceboDrug
0.9% sodium chloride solution
| Study group | Role | What they receive |
|---|---|---|
| RSLV-132 | Experimental | Intravenous infusions of 10 mg/kg RSLV-132 solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment Receives: Drug: RSLV-132 |
| Placebo | Placebo comparator | Intravenous infusions of placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of cardinal symptoms of Sjogren's
Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument
Measured: Measured daily from at least 7 days prior to first dose until 169 days after the first dose
Secondary outcomes (4)
Tiredness/fatigue assessment
Change from baseline in the Patient Reported Outcomes Measurement Information System Fatigue Short Form 10a (PROMIS SF10a) on Day 169
Measured: Measured from before the first dose until Day 169
RSLV-132 pharmacokinetics
Serum concentrations of RSLV-132 using an assay measuring RNAse enzyme activity
Measured: Measured from before the first dose until Day 211
RSLV-132 immunogenicity
Presence of antibodies to RSLV-132 measured using an immunoassay
Measured: Measured from before the first dose until Day 211
Adverse events
Incidence of serious and non-serious adverse events
Measured: From the first dose of Investigational Product until Day 211
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Dec 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resolve Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Posada, Study director, Resolve Therapeutics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440525
- Sponsor's protocol ID
- 132-6
- Status last verified
- Oct 2026
- First submitted
- 28 May 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Posada J, Valadkhan S, Burge D, Davies K, Tarn J, Casement J, Jobling K, Gallagher P, Wilson D, Barone F, Fisher BA, Ng WF. Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjogren's Syndrome: A Randomized Clinical Trial. Arthritis Rheumatol. 2021 Jan;73(1):143-150. doi: 10.1002/art.41489. Epub 2020 Nov 22.
PubMed 32798283Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
PubMed 27785888
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06440525
- Acronym / sponsor ID
- 132-6
- Conditions
- Primary Sjögren Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Resolve TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are:
- Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain?
- Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's?
- What are the blood levels of RSLV-132 over time?
- What is the immune (antibody) response in the body to RSLV-132?
- What is the safety profile of RSLV-132?
Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS.
Participants will:
Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSLV-132 | Experimental | Drug: RSLV-132Intravenous infusions of 10 mg/kg RSLV-132 solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous infusions of placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSLV-132Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1) | Drug | RSLV-132 |
| Placebo0.9% sodium chloride solution | Drug | Placebo |
Primary outcome
Assessment of cardinal symptoms of Sjogren's
Time frame: Measured daily from at least 7 days prior to first dose until 169 days after the first dose
Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument
4 secondary outcomes
Tiredness/fatigue assessment
Time frame: Measured from before the first dose until Day 169
RSLV-132 pharmacokinetics
Time frame: Measured from before the first dose until Day 211
RSLV-132 immunogenicity
Time frame: Measured from before the first dose until Day 211
Adverse events
Time frame: From the first dose of Investigational Product until Day 211
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 32798283Posada J, Valadkhan S, Burge D, Davies K, Tarn J, Casement J, Jobling K, Gallagher P, Wilson D, Barone F, Fisher BA, Ng WF. Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjogren's Syndrome: A Randomized Clinical Trial. Arthritis Rheumatol. 2021 Jan;73(1):143-150. doi: 10.1002/art.41489. Epub 2020 Nov 22.
- Background: PubMed 27785888Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Posada study director
Resolve Therapeutics LLC
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RSLV-132 in people with Primary Sjögren Syndrome, run by Resolve Therapeutics at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of cardinal symptoms of Sjogren's (time frame: Measured daily from at least 7 days prior to first dose until 169 days after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06440525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.