Can a new biologic ease rheumatoid arthritis when standard drugs fail?

NCT ID NCT07796516

Disease control Sponsor: Peking University People's Hospital Source: ClinicalTrials.gov ↗

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether telitacicept, an experimental biologic given as a weekly injection, can improve symptoms in people with difficult-to-treat rheumatoid arthritis. Participants receive either telitacicept plus standard therapy or standard therapy alone for 24 weeks. The study measures how many people achieve a 20% improvement in symptoms, along with other measures of disease activity. The goal is to see if this drug offers relief for those who have not responded to existing treatments.

What this could mean

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

Active substance: telitacicept, an experimental biologic given as a weekly injection
What this could lead to: If it works, telitacicept could offer a new treatment option for people with rheumatoid arthritis who have not gotten relief from standard drugs.
What could go wrong: This is an early-phase trial, so the drug may not prove more effective than standard care. It also carries risks common to biologics, such as infections or allergic reactions.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 420 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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 and Female participants of age \>18 years will be enrolled; 2. Meet the 2021 EULAR criteria for the diagnosis of difficult-to-treat rheumatoid arthritis; 3. The dose of prednisone should be ≤10 mg or equivalent dose of corticosteroids, and the dose must remain unchanged for at least 4 weeks; 4. Consent to use effective contraception during the study period (women of childbearing age); 5. Voluntarily signed informed consent. Exclusion Criteria: 1. Those with specific allergy history (asthma, urticaria, eczema, etc.), or allergic constitution, or hypersensitivity to any component of telitacicept; 2. Subjects who have received intra-articular, intravenous, intramuscular, or intrarectal (excluding suppositories for anal diseases) corticosteroids within 4 weeks prior to baseline; 3. Subjects who have used Tripterygium wilfordii glycosides, total glucosides of paeony, Huobahuagen tablets, or other immunosuppressive or anti-inflammatory traditional Chinese medicines or decoctions within 4 weeks prior to baseline; 4. Subjects currently using non-steroidal anti-inflammatory drugs (excluding acetaminophen) whose dose has not been stable for 4 weeks prior to randomization, or who are unable to continue treatment at the original dose during the trial; 5. Subjects with abnormal laboratory parameters, including but not limited to the following: * White blood cell count \< 2.0 × 10⁹/L; * Neutrophils \< 1.0 × 10⁹/L; * Hemoglobin \< 80 g/L; * Platelet count \< 50 × 10⁹/L; * Serum creatinine \> 2 × ULN or creatinine clearance (CCr) ≤ 50 mL/min * Total bilirubin \> 2 × ULN, ALT \> 3 × ULN, AST \> 3 × ULN, alkaline phosphatase \> 2 × ULN; 6. Female subjects who are pregnant or breastfeeding; 7. Those with other systemic inflammatory diseases other than RA (excluding secondary Sjögren's syndrome), including but not limited to juvenile chronic arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis, reactive arthropathy, systemic vasculitis, or gout; 8. Those with non-inflammatory refractory arthritis (NIRRA) (few or no swollen joints, normal CRP concentration, non-erosive pathology); 9. Subjects who test positive for any one or more of the following: hepatitis B surface antigen, hepatitis C virus antibody, syphilis-specific antibody, or human immunodeficiency virus antibody; 10. Subjects with active infection at screening, or who have had an infection requiring systemic treatment within 1 month prior to screening, or who are at high risk of infection; 11. Subjects with clinical, radiological, or laboratory evidence of active tuberculosis at screening; 12. Subjects with clinically significant cardiovascular, respiratory, digestive, endocrine, hematologic, neurological, or psychiatric disorders, or any other serious and/or unstable disease or history thereof, that in the investigator's opinion would pose a safety risk if participating in this study; 13. Subjects with other primary malignancies; 14. Subjects with a history of herpes zoster, major cardiovascular events, thromboembolism, or lymphoproliferative disease; 15. Investigator considers candidates not appropriating for the study.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

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

Difficult-to-treat rheumatoid arthritis Rheumatoid arthritis

How to take part

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

The places running it

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

Locations

Affiliated Hospital of Yangzhou University
NOT_YET_RECRUITING

Yangzhou, Jiangsu, China
Anhui Provincial Hospital
NOT_YET_RECRUITING

Hefei, Anhui, China
Army Characteristic Medical Center
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, China
Bethune First Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, China
Dalian University of Technology Affiliated Central Hospital
NOT_YET_RECRUITING

Dalian, Liaoning, China
Dongying People's Hospital
NOT_YET_RECRUITING

Dongying, Shandong, China
First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING

Hefei, Anhui, China
First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING

Nanning, Guangxi, China
First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING

Harbin, Heilongjiang, China
First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING

Kunming, Yunnan, China
First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING

Nanchang, Jiangxi, China
First Affiliated Hospital of University of South China
NOT_YET_RECRUITING

Hengyang, Hunan, China
First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING

Wenzhou, Zhejiang, China
First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING

Ürümqi, Xinjiang, China
First People's Hospital of Yunnan Province
NOT_YET_RECRUITING

Kunming, Yunnan, China
General Hospital of Central Theater Command of the PLA
NOT_YET_RECRUITING

Wuhan, Hubei, China
General Hospital of Hunan University of Medicine
NOT_YET_RECRUITING

Huaihua, Hunan, China
General Hospital of Northern Theater Command
NOT_YET_RECRUITING

Shenyang, Liaoning, China
Hainan General Hospital
NOT_YET_RECRUITING

Haikou, Hainan, China
Henan Provincial People's Hospital
NOT_YET_RECRUITING

Zhengzhou, Henan, China
Huaihe Hospital of Henan University
NOT_YET_RECRUITING

Kaifeng, Henan, China
Hunan Provincial People's Hospital
NOT_YET_RECRUITING

Changsha, Hunan, China
Jiangmen Central Hospital
NOT_YET_RECRUITING

Jiangmen, Guangdong, China
Jilin Provincial People's Hospital
NOT_YET_RECRUITING

Changchun, Jilin, China
Linfen People's Hospital
NOT_YET_RECRUITING

Linfen, Shanxi, China
Linyi People's Hospital
NOT_YET_RECRUITING

Linyi, Shandong, China
Nantong First People's Hospital
NOT_YET_RECRUITING

Nantong, Jiangsu, China
Ningbo Hospital of Integrated Traditional Chinese and Western Medicine
NOT_YET_RECRUITING

Ningbo, Zhejiang, China
Peking University People's Hospital
RECRUITING

Beijing, Beijing Municipality, 100044, China
Peking University Shenzhen Hospital
NOT_YET_RECRUITING

Shenzhen, Guangdong, China
Qingdao Branch of Qilu Hospital of Shandong University
NOT_YET_RECRUITING

Qingdao, Shandong, China
Qingdao Municipal Hospital
NOT_YET_RECRUITING

Qingdao, Shandong, China
Second Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING

Quanzhou, Fujian, China
Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING

Harbin, Heilongjiang, China
Second Hospital of Hebei Medical University
NOT_YET_RECRUITING

Shijiazhuang, Hebei, China
Shanghai Tongji Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, China
Shengjing Hospital of China Medical Universit
NOT_YET_RECRUITING

Shenyang, Liaoning, China
Shengli Oilfield Central Hospital
NOT_YET_RECRUITING

Dongying, Shandong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING

Guangzhou, Guangdong, China
The First Hospital of Shanxi Medical University
NOT_YET_RECRUITING

Taiyuan, Shanxi, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING

Wuhan, Hubei, China
Weifang People's Hospital
NOT_YET_RECRUITING

Weifang, Shandong, China
Wuhan Central Hospital
NOT_YET_RECRUITING

Wuhan, Hubei, China
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING

Yantai, Shandong, China
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING

Wuhan, Hubei, China
Zhujiang Hospital of Southern Medical University
NOT_YET_RECRUITING

Guangzhou, Guangdong, China
Zibo Central Hospital
NOT_YET_RECRUITING

Zibo, Shandong, China

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