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New drug telitacicept aims to tame Sjögren's in major trial

NCT ID NCT07404865

Disease control Sponsor: Vor Biopharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 7 times

Summary

This Phase 3 study tests whether telitacicept, a biologic drug given as a shot, can reduce disease activity in adults with active primary Sjögren's disease. About 250 participants will receive either telitacicept or a placebo for 48 weeks. The main goal is to see if the drug improves a standard disease activity score.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
telitacicept (a biologic drug given as a shot under the skin)
What this could lead to
If it works, telitacicept could become a new treatment option to control Sjögren's disease activity and improve symptoms.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary Sjogren's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    43 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Accurate Clinical Research

    RECRUITING

    Baytown, Texas, 77521, United States

  • Accurate Clinical Research, Inc.

    RECRUITING

    Lake Charles, Louisiana, 70605, United States

  • Accurate Clinical Research, Inc.

    RECRUITING

    Houston, Texas, 77089, United States

  • Allen Arthritis

    RECRUITING

    Allen, Texas, 75013, United States

  • Altoona Center for Clinical Research, P.C.

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Amarillo Premier Research, LLC

    RECRUITING

    Amarillo, Texas, 79124, United States

  • Arizona Arthritis & Rheumatology Associates P.C.

    RECRUITING

    Chandler, Arizona, 85225, United States

  • Arizona Arthritis & Rheumatology Associates P.C.

    RECRUITING

    Flagstaff, Arizona, 86001, United States

  • Arizona Arthritis & Rheumatology Associates P.C.

    RECRUITING

    Phoenix, Arizona, 85392, United States

  • Arizona Arthritis & Rheumatology Associates, P.C.

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Arizona Arthritis & Rheumatology Associates, PLLC

    RECRUITING

    Glendale, Arizona, 85306, United States

  • Arthritis and Osteoporosis Consultants of the Carolinas

    RECRUITING

    Charlotte, North Carolina, 28202, United States

  • Arthritis and Rheumatism Associates

    RECRUITING

    Rockville, Maryland, 20850, United States

  • Arthritis and Rheumatology Research Institute, PLLC

    RECRUITING

    Allen, Texas, 75013, United States

  • Bioresearch Partner

    RECRUITING

    South Miami, Florida, 33143, United States

  • Bioresearch Partners

    RECRUITING

    South Miami, Florida, 33143, United States

  • Chicago Clinical Research Institute Inc

    RECRUITING

    Chicago, Illinois, 60607, United States

  • Clinical Investigation Specialist

    RECRUITING

    Schaumburg, Illinois, 60195, United States

  • Clinical Research Institute of Michigan, LLC

    RECRUITING

    Saint Clair Shores, Michigan, 48081, United States

  • Clinical Research of West Florida - Corporate

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida, Inc.

    RECRUITING

    Tampa, Colorado, 33606, United States

  • Clinical Research of West Florida, Inc.

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Conquest Research

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Denver Arthritis Clinic

    RECRUITING

    Denver, Colorado, 80230, United States

  • Finlay Medical Research Corp

    RECRUITING

    Green Acres, Florida, 33467, United States

  • GNP Research

    RECRUITING

    Cooper City, Florida, 33024, United States

  • Helios CR Inc - Dallas, TX

    RECRUITING

    Dallas, Texas, 75231, United States

  • Kansas City Physician Partners

    RECRUITING

    Kansas City, Missouri, 64151, United States

  • Lone Star Arthritis & Rheumatology

    RECRUITING

    Fort Worth, Texas, 76109, United States

  • Novel Research LLC

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Precision Comprehensive Clinical Research Solution

    RECRUITING

    Irving, Texas, 75061, United States

  • Precision Comprehensive Clinical Research Solutions

    RECRUITING

    Euless, Texas, 76040, United States

  • R&H Clinical Research Inc.

    RECRUITING

    Katy, Texas, 77450, United States

  • Rheumatic Disease Associates, Ltd.

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Sarasota Arthritis Center

    RECRUITING

    Sarasota, Florida, 34239, United States

  • St. Luke's Clinic - Rheumatology

    RECRUITING

    Boise, Idaho, 83702, United States

  • Suncoast Clinical Research Inc.

    RECRUITING

    New Port Richey, Florida, 34652, United States

  • Tekton Research

    RECRUITING

    Fort Collins, Colorado, 80528, United States

  • Tidewater Clinical Research

    RECRUITING

    Chesapeake, Virginia, 23320, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • Velocity Clinical Research, Waco

    RECRUITING

    Waco, Texas, 76710, United States

  • Wallace Rheumatic Study Center

    RECRUITING

    Beverly Hills, California, 90210, United States

  • Willow Rheumatology & Wellness

    RECRUITING

    Willowbrook, Illinois, 60527, United States