Primary Sjogren's DiseasePhase 3UPSTREAM SjDNCT07404865
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
A Phase 3 study testing Telitacicept in people with Primary Sjogren's Disease, run by Vor Biopharma at 49 sites in 2 countries.
Trial summary
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjogren's Disease
- What is being tested?
- Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 49 sitesin 2 countries
- Study dates
- 26 Feb 2026to Jan 2029
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 75 years of age (both inclusive) at screening
- Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening.
- ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)
- Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
- Additional inclusion criteria are defined in the protocol
Who cannot join
- Participants who have a systemic autoimmune disease other than Primary Sjogren's Disease, such as rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis, that can better explain the majority of the symptoms (i.e., secondary Sjogren's Disease)
- Participants who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of Primary Sjogren's Disease to therapy (e.g., systemic sclerosis, inflammatory bowel disease, gout).
- Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy
- Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation
- Significant, uncontrolled medical disease in any organ system not related to Primary Sjogren's Disease (e.g., poorly controlled asthma, cardiovascular disease, accelerated hypertension, major depression, etc.) that in the opinion of the investigator would preclude participant participation.
- Additional exclusion criteria are defined in the protocol
Trial locations and contacts
49 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
49 sites in 2 countries
United States47 sites, 47 recruiting
- Recruiting
Allen Arthritis
Allen, Texas, 75013
- Recruiting
Arthritis and Rheumatology Research Institute, PLLC
Allen, Texas, 75013
- Recruiting
Amarillo Premier Research, LLC
Amarillo, Texas, 79124
- Recruiting
Accurate Clinical Research
Baytown, Texas, 77521
- Recruiting
Novel Research LLC
Bellaire, Texas, 77401
- Recruiting
Wallace Rheumatic Study Center
Beverly Hills, California, 90210
- Recruiting
St. Luke's Clinic - Rheumatology
Boise, Idaho, 83702
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
Arizona Arthritis & Rheumatology Associates P.C.
Chandler, Arizona, 85225
- Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28202
- Recruiting
Tidewater Clinical Research
Chesapeake, Virginia, 23320
- Recruiting
Chicago Clinical Research Institute Inc
Chicago, Illinois, 60607
- Recruiting
Clinical Research of West Florida - Corporate
Clearwater, Florida, 33765
- Recruiting
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
- Recruiting
GNP Research
Cooper City, Florida, 33024
- Recruiting
Helios CR Inc - Dallas, TX
Dallas, Texas, 75231
- Recruiting
Denver Arthritis Clinic
Denver, Colorado, 80230
- Recruiting
Altoona Center for Clinical Research, P.C.
Duncansville, Pennsylvania, 16635
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
Precision Comprehensive Clinical Research Solutions
Euless, Texas, 76040
- Recruiting
Arizona Arthritis & Rheumatology Associates P.C.
Flagstaff, Arizona, 86001
- Recruiting
Tekton Research
Fort Collins, Colorado, 80528
- Recruiting
Lone Star Arthritis & Rheumatology
Fort Worth, Texas, 76109
- Recruiting
Arizona Arthritis & Rheumatology Associates, PLLC
Glendale, Arizona, 85306
- Recruiting
Finlay Medical Research Corp
Green Acres, Florida, 33467
- Recruiting
Accurate Clinical Research, Inc.
Houston, Texas, 77089
- Recruiting
Precision Comprehensive Clinical Research Solution
Irving, Texas, 75061
- Recruiting
Kansas City Physician Partners
Kansas City, Missouri, 64151
- Recruiting
R&H Clinical Research Inc.
Katy, Texas, 77450
- Recruiting
Accurate Clinical Research, Inc.
Lake Charles, Louisiana, 70605
- Recruiting
Clever Medical Research
Miami, Florida, 33126
- Recruiting
Suncoast Clinical Research Inc.
New Port Richey, Florida, 34652
- Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
- Recruiting
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
- Recruiting
Arizona Arthritis & Rheumatology Associates P.C.
Phoenix, Arizona, 85392
- Recruiting
Arthritis and Rheumatism Associates
Rockville, Maryland, 20850
- Recruiting
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, 48081
- Recruiting
Sarasota Arthritis Center
Sarasota, Florida, 34239
- Recruiting
Clinical Investigation Specialist
Schaumburg, Illinois, 60195
- Recruiting
Bioresearch Partners
South Miami, Florida, 33143
- Recruiting
Bioresearch Partner
South Miami, Florida, 33143
- Recruiting
Clinical Research of West Florida, Inc.
Tampa, Colorado, 33606
- Recruiting
Arizona Arthritis & Rheumatology Associates, P.C.
Tucson, Arizona, 85704
- Recruiting
Velocity Clinical Research, Waco
Waco, Texas, 76710
- Recruiting
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, 19090
- Recruiting
Willow Rheumatology & Wellness
Willowbrook, Illinois, 60527
- Recruiting
Conquest Research
Winter Park, Florida, 32789
Georgia2 sites, 2 recruiting
- Recruiting
Innova LLC
Tbilisi
- Recruiting
The First Medical Center LLC
Tbilisi
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants With Active Primary Sjögren's Disease
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Read the detailed description
Telitacicept (RC18) is a recombinant fusion protein designed to target B-cell-mediated immune pathways. It consists of the extracellular domain of transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) linked to the Fc portion of human immunoglobulin G1 (IgG1).
Telitacicept binds with high affinity to the cytokines B-lymphocyte stimulator (BLyS, also known as BAFF) and A Proliferation-Inducing Ligand (APRIL). By binding these soluble factors, telitacicept prevents their interaction with cell-surface receptors on B cells, including TACI, B-cell maturation antigen (BCMA), and BAFF receptor (BAFF-R).
This inhibition reduces BLyS/APRIL signaling, leading to decreased B-cell survival, reduced differentiation of B cells into immunoglobulin-producing plasma cells, and lowering of autoantibody production, increased BLyS and APRIL levels, B-cell hyperactivity, and autoantibody production are associated with multiple autoimmune diseases.
Modulation of the BLyS/APRIL pathway is intended to reduce pathogenic B-cell activity and downstream immune effects that contribute to disease manifestations in Sjogren's disease and other B-cell-mediated autoimmune conditions.
- Conditions
- Primary Sjogren's Disease
- Being tested
- Telitacicept, Placebo
- Keywords
- Sjögren's Disease, pSD, Primary Sjogren's Syndrome, Sjogren's Syndrome, SjD
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptBiological
Also called RC18, RC18-L
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept | Experimental | Telitacicept Receives: Biological: Telitacicept |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
Measured: Week 48
Secondary outcomes (6)
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.
Measured: Week 48
To evaluate the efficacy of telitacicept versus placebo in improving glandular function during the trial.
Change from baseline in the stimulated whole salivary flow at Week 48.
Measured: Week 48
To evaluate the effect of telitacicept versus placebo in improving patient-reported outcomes (i.e., how participants feel and function) during the trial.
Change from baseline in the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score at Week 48
Measured: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the physician's global assessment of disease activity (Physician GDA) score at Week 48
Change from baseline in the physician's global assessment of disease activity (Physician GDA) score at Week 48
Measured: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Measured: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the participant's global assessment of disease activity (Patient GDA) at Week 48.
Change from baseline in the participant's global assessment of disease activity (Patient GDA) at Week 48.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start26 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjogren's DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vor Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404865
- Sponsor's protocol ID
- RC18G007
- Other IDs
- pSD, Telitacicept, UPSTREAM SjD
- Acronym
- UPSTREAM SjD
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants With Active Primary Sjögren's Disease
- ClinicalTrials.gov ID
- NCT07404865
- Acronym / sponsor ID
- UPSTREAM SjD / RC18G007
- Conditions
- Primary Sjogren's Disease
- Keywords
- Sjögren's Disease, pSD, Primary Sjogren's Syndrome, Sjogren's Syndrome, SjD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Vor BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 Feb 2026 (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.
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Detailed description
Telitacicept (RC18) is a recombinant fusion protein designed to target B-cell-mediated immune pathways. It consists of the extracellular domain of transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) linked to the Fc portion of human immunoglobulin G1 (IgG1).
Telitacicept binds with high affinity to the cytokines B-lymphocyte stimulator (BLyS, also known as BAFF) and A Proliferation-Inducing Ligand (APRIL). By binding these soluble factors, telitacicept prevents their interaction with cell-surface receptors on B cells, including TACI, B-cell maturation antigen (BCMA), and BAFF receptor (BAFF-R).
This inhibition reduces BLyS/APRIL signaling, leading to decreased B-cell survival, reduced differentiation of B cells into immunoglobulin-producing plasma cells, and lowering of autoantibody production, increased BLyS and APRIL levels, B-cell hyperactivity, and autoantibody production are associated with multiple autoimmune diseases.
Modulation of the BLyS/APRIL pathway is intended to reduce pathogenic B-cell activity and downstream immune effects that contribute to disease manifestations in Sjogren's disease and other B-cell-mediated autoimmune conditions.
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 |
|---|---|---|
| Telitacicept | Experimental | Biological: TelitaciceptTelitacicept |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 to 75 years of age (both inclusive) at screening
- Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening.
- ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)
- Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
- Additional inclusion criteria are defined in the protocol
Key exclusion criteria (6 listed)
- Participants who have a systemic autoimmune disease other than Primary Sjogren's Disease, such as rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis, that can better explain the majority of the symptoms (i.e., secondary Sjogren's Disease)
- Participants who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of Primary Sjogren's Disease to therapy (e.g., systemic sclerosis, inflammatory bowel disease, gout).
- Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy
- Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation
- Significant, uncontrolled medical disease in any organ system not related to Primary Sjogren's Disease (e.g., poorly controlled asthma, cardiovascular disease, accelerated hypertension, major depression, etc.) that in the opinion of the investigator would preclude participant participation.
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 |
|---|---|---|
| TelitaciceptAlso: RC18, RC18-LSubcutaneous injection | Biological | Telitacicept |
| PlaceboSubcutaneous injection | Drug | Placebo |
Primary outcome
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
Time frame: Week 48
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
6 secondary outcomes
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo in improving glandular function during the trial.
Time frame: Week 48
To evaluate the effect of telitacicept versus placebo in improving patient-reported outcomes (i.e., how participants feel and function) during the trial.
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the physician's global assessment of disease activity (Physician GDA) score at Week 48
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the participant's global assessment of disease activity (Patient GDA) at Week 48.
Time frame: Week 48
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 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telitacicept in people with Primary Sjogren's Disease, run by Vor Biopharma at 49 sites in 2 countries.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 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 49 sites in United States, Georgia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Jeremy Sokolove (6176556580, Study@vorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48. (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.