Recruiting
Phase 3

Telitacicept

Sponsor:

Vor Biopharma

Code:

NCT07404865

Conditions

Primary Sjogren's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Telitacicept

Placebo

Study Details

Brief summary:

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)

Conditions

Primary Sjogren's Disease

Study ID

NCT07404865

Start date

Feb 26, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female aged 18 to 75 years of age (both inclusive) at screening
2. Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening.
3. ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)
4. 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

Exclusion Criteria:

1. 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)
2. 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).
3. Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy
4. Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation
5. 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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telitacicept

Telitacicept

placebo comparator: Placebo

Placebo

Interventions

Telitacicept

Subcutaneous injection

Placebo

Subcutaneous injection

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 ]

Central Contacts and Locations

Central contacts

Jeremy Sokolove

6176556580Study@vorbio.com

Locations

Arizona Arthritis & Rheumatology Associates P.C.

Recruiting

Chandler, Arizona, United States, 85225

Arizona Arthritis & Rheumatology Associates P.C.

Recruiting

Flagstaff, Arizona, United States, 86001

Arizona Arthritis & Rheumatology Associates, PLLC

Recruiting

Glendale, Arizona, United States, 85306

Arizona Arthritis & Rheumatology Associates P.C.

Recruiting

Phoenix, Arizona, United States, 85392

Arizona Arthritis & Rheumatology Associates, P.C.

Recruiting

Tucson, Arizona, United States, 85704

Wallace Rheumatic Study Center

Recruiting

Beverly Hills, California, United States, 90210

Denver Arthritis Clinic

Recruiting

Denver, Colorado, United States, 80230

Tekton Research

Recruiting

Fort Collins, Colorado, United States, 80528

Clinical Research of West Florida, Inc.

Recruiting

Tampa, Colorado, United States, 33606

Clinical Research of West Florida - Corporate

Recruiting

Clearwater, Florida, United States, 33765

Clinical Research of West Florida, Inc.

Recruiting

Clearwater, Florida, United States, 33765

GNP Research

Recruiting

Cooper City, Florida, United States, 33024

Finlay Medical Research Corp

Recruiting

Green Acres, Florida, United States, 33467

Suncoast Clinical Research Inc.

Recruiting

New Port Richey, Florida, United States, 34652

Sarasota Arthritis Center

Recruiting

Sarasota, Florida, United States, 34239

Bioresearch Partners

Recruiting

South Miami, Florida, United States, 33143

Bioresearch Partner

Recruiting

South Miami, Florida, United States, 33143

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

St. Luke's Clinic - Rheumatology

Recruiting

Boise, Idaho, United States, 83702

Chicago Clinical Research Institute Inc

Recruiting

Chicago, Illinois, United States, 60607

Clinical Investigation Specialist

Recruiting

Schaumburg, Illinois, United States, 60195

Willow Rheumatology & Wellness

Recruiting

Willowbrook, Illinois, United States, 60527

Accurate Clinical Research, Inc.

Recruiting

Lake Charles, Louisiana, United States, 70605

Arthritis and Rheumatism Associates

Recruiting

Rockville, Maryland, United States, 20850

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Clinical Research Institute of Michigan, LLC

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Kansas City Physician Partners

Recruiting

Kansas City, Missouri, United States, 64151

Arthritis and Osteoporosis Consultants of the Carolinas

Recruiting

Charlotte, North Carolina, United States, 28202

Altoona Center for Clinical Research, P.C.

Recruiting

Duncansville, Pennsylvania, United States, 16635

Rheumatic Disease Associates, Ltd.

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Allen Arthritis

Recruiting

Allen, Texas, United States, 75013

Arthritis and Rheumatology Research Institute, PLLC

Recruiting

Allen, Texas, United States, 75013

Amarillo Premier Research, LLC

Recruiting

Amarillo, Texas, United States, 79124

Accurate Clinical Research

Recruiting

Baytown, Texas, United States, 77521

Novel Research LLC

Recruiting

Bellaire, Texas, United States, 77401

Helios CR Inc - Dallas, TX

Recruiting

Dallas, Texas, United States, 75231

Precision Comprehensive Clinical Research Solutions

Recruiting

Euless, Texas, United States, 76040

Lone Star Arthritis & Rheumatology

Recruiting

Fort Worth, Texas, United States, 76109

Accurate Clinical Research, Inc.

Recruiting

Houston, Texas, United States, 77089

Precision Comprehensive Clinical Research Solution

Recruiting

Irving, Texas, United States, 75061

R&H Clinical Research Inc.

Recruiting

Katy, Texas, United States, 77450

Velocity Clinical Research, Waco

Recruiting

Waco, Texas, United States, 76710

Tidewater Clinical Research

Recruiting

Chesapeake, Virginia, United States, 23320

More Information

Sponsor

Vor Biopharma

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Sjögren's Disease
  • pSD
  • Primary Sjogren's Syndrome
  • Sjogren's Syndrome
  • SjD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Vor Biopharma on 2026-08-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.