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New drug shows promise for Sjogren's sufferers in major trial

NCT ID NCT05673993

Disease control Sponsor: RemeGen Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called telitacicept in 381 adults with active primary Sjogren's syndrome, an autoimmune disease causing dry eyes and mouth. Participants received either the drug or a placebo to see if it safely reduces disease activity. The goal is to control the condition, not cure it.

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

381 people

The number who actually took part.

Started

Apr 2023

Finished

May 2025

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 70 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.

Main Inclusion Criteria: 1. Written informed consent provided. 2. Males and females, 18-70 years of age. 3. Fulfilled the classification criteria of pSS according to ACR/EULAR (2016). 4. Anti-SSA antibody tested positive at screening. 5. ESSDAI score ≥ 5 at screening. Main Exclusion Criteria: 1. Secondary Sjogren's syndrome. 2. Severe organ involvement related to pSS in the opinion of the investigator, including but not limited to a) severe vasculitis (not cutaneous vasculitis) affecting the kidney, gastrointestinal system, cardiac, pulmonary or central nervous system (CNS); b) active CNS or peripheral nervous system involvement requiring high dose corticosteroids; c) severe kidney involvement, e.g. GFR \< 60 ml/min, serum creatinine \> 2 mg/dL, or proteinuria \> 3g/d; d) severe pulmonary involvement, e.g. shortness of breath at rest, FVC \< 60% or DLCO \< 40%; e) muscle diseases requiring high dose corticosteroids; f) lymphoma. 3. Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening. 4. Received live vaccine within 28 days prior to randomization. 5. Active hepatitis or history of severe liver diseases. 6. HIV positive. 7. Patients with malignant tumors. 8. Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer. 9. Nursing or pregnant female, or male or female who prepared for parenthood during the study. 10. Any condition that, in the opinion of the investigator, makes it unsuitable for the subject to participate, e.g., poorly controlled high blood pressure, diabetes, heart failure or mental illness.

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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 syndrome

Contacts and locations

Locations

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, China

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, China

  • Anhui Provincial Hospital

    Hefei, Anhui, China

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Binzhou Medical University Hospital

    Binzhou, Shandong, China

  • Deyang People's Hospital

    Deyang, Sichuan, China

  • Dongyang People's Hospital

    Dongyang, Zhejiang, China

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, China

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, China

  • Guilin People's Hospital

    Guilin, Guangxi, China

  • Hebei PetroChina Central Hospital

    Langfang, Hebei, China

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, China

  • Hunan Provincial People's Hospital

    Changsha, Hunan, China

  • Huzhou Third Municipal Hospital

    Huzhou, Zhejiang, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, China

  • Jilin Province People's Hospital

    Changchun, Jilin, China

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, China

  • Jining No 1 People's Hospital

    Jining, Shandong, China

  • Liuzhou Workers' Hospital

    Liuzhou, Guangxi, China

  • Meizhou People's Hospital

    Meizhou, Guangdong, China

  • Mianyang Central Hospital

    Mianyang, Sichuan, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

  • Ningbo Medical Center (Lihuili Hospital)

    Ningbo, Zhejiang, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, China

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, China

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, China

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • Shandong Provincial Hospital

    Jinan, Shandong, China

  • Shanghai Ninth People's Hopital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, China

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, China

  • South China Hospital of Shenzhen University

    Shenzhen, Guangdong, China

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, China

  • The Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, China

  • The First Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, China

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, China

  • The First People's Hospital of Changde

    Changde, Hunan, China

  • The First People's Hospital of Chenzhou

    Chenzhou, Hunan, China

  • The First People's Hospital of Wenling

    Wenling, Zhejiang, China

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, China

  • The People's Hospital of Wenzhou

    Wenzhou, Zhejiang, China

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian, China

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, China

  • The Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Second Hospital of Jiaxing

    Jiaxing, Zhejiang, China

  • The Second People's Hospital of Changzhou

    Changzhou, Jiangsu, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, China

  • West China Hospital Sichuan University

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing Municipality, China

  • Yanbian University Hospital (Yanbian Hospital)

    Yanji, Jilin, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, China

  • Yantaishan Hospital

    Yantai, Shandong, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

  • Zhongshan Hospital of Traditional Chinese Medicine

    Zhongshan, Guangdong, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.