Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
NCT ID: NCT05998759
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
296 participants
INTERVENTIONAL
2023-12-02
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Telitacicept plus standard therapy
Telitacicept (160mg ih qw for 24 weeks) combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.).
Telitacicept
subcutaneous telitacicept 160 mg weekly for 24 weeks.
Placebo plus standard therapy
Placebo combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.).
Placebo
subcutaneous placebo weekly for 24 weeks.
Interventions
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Telitacicept
subcutaneous telitacicept 160 mg weekly for 24 weeks.
Placebo
subcutaneous placebo weekly for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Refractory thrombocytopenia defined as:
Either: Failure to maintain sustained remission after treatment by glucocorticoid and at least one immunosuppressant (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate, leflunomide and hydroxychloroquine, et al.) Or: Relapse during oral glucocorticoid tapering or after withdrawal
* 50×10\^9/L\>PLT
* anti-nuclear antibody (ANA) positive (≥1:80, any karyotype) detected in the laboratory of each research center
* Standard therapy should be maintained stable for at least 14 days prior to the first dose of the experimental drug or placebo. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.)
* Signed informed consent form, willing or able to participate in all required study evaluations and procedures
Exclusion Criteria
* Antiphospholipid syndrome, thrombotic thrombocytopenia purpura, hemolytic uremic syndrome, or thrombocytopenia secondary to other causes (such as sepsis, Epstein-Barr virus infection, cytomegalovirus infection, Corona Virus Disease-19 (COVID-19) infection, drugs, etc.)
* Hematopoietic system disorders, such as myelodysplastic syndrome, paroxysmal sleep hemoglobinuria, aplastic anemia, leukemia, lymphoma, myelofibrosis and so on
* Severe cardiovascular system disease, including: unstable or uncontrollable disease or condition affecting the function of the heart (such as angina pectoris, congestive heart failure, uncontrolled hypertension or arrhythmia)
* Arteriovenous thromboembolism events
* Receiving antiplatelet or anticoagulant therapy at screening
* Clinically significant electrocardiogram changes
* corrected Q-T interval (QTc)\>450ms for male, QTc\>470ms for female
* Severe pulmonary disease, including: unstable or uncontrollable disease or condition affecting respiratory function \[e.g., diffuse alveolar hemorrhage, severe pulmonary hypertension, severe pulmonary interstitial disease (peripheral blood oxygen saturation \<92% at rest without oxygen, or forced vital capacity (FVC)\<50%, or carbon monoxide diffusing capacity (DLCO)\<50%)\]
* Severe kidney disease, including: severe lupus nephritis (urinary protein \> 6 g/24 hours or endogenous creatinine clearance \< 30 ml /min) 8 weeks prior to randomization, active nephritis requiring current protocol disallowed drugs, severe renal insufficiency requiring hemodialysis or prednisone ≥100mg/ day (or equivalent) for ≥14 days
* SLE or non-SLE related central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) 8 weeks prior to randomization
* Active hepatitis, a history of severe liver disease. Subjects positive for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus are excluded. As for subjects with antibodies to hepatitis B core antigen (HBcAb), further hepatitis B virus (HBV)-DNA should be tested. If HBV-DNA is negative, subjects could be enrolled; otherwise, subjects should be excluded
* Abnormal laboratory results (including but not limited to: alanine aminotransferase (ALT) or aspertate aminotransferase (AST)≥3×ULN (upper limit of normal), white blood cell count \<1.5×10\^9/L)
* Subjects with known active infections (e.g., shingles, COVID-19, HIV, active tuberculosis, etc.), and active or recurrent gastrointestinal ulcers
* Pregnant or lactating women, and subjects with a during plan during the trial
* Allergic reaction: history of allergic reactions to human biological products
* Treatment with B cell-targeting agents such as Rituximab or Epratuzumab or Belimumab six months prior to randomization
* Treatment with tumor necrosis factor (TNF) inhibitors or TNF-receptor blockers six months prior to randomization
* Participating in clinical trial 28 days or 5 drug half-lives of the investigational agents prior to randomization
* Received live vaccine 28 days prior to randomization
* Treatment with unstable dosage of thrombopoietin receptor agonists such as Eltrombopag or Romiplostim 14 days prior to randomization
* Subjects with depression or suicidal thoughts
* Previous treatment with telitacicept
* B cell targeting drug therapy is not tolerated or responsive
* Investigator considers candidates not appropriating for the study
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Anhui Medical University
OTHER
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
OTHER
Peking University People's Hospital
OTHER
Peking University Third Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Guangdong Provincial People's Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Second Xiangya Hospital of Central South University
OTHER
Xiangya Hospital of Central South University
OTHER
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
First Hospital of China Medical University
OTHER
Shandong Provincial Hospital
OTHER_GOV
Changhai Hospital
OTHER
RenJi Hospital
OTHER
Shanxi Bethune Hospital
OTHER
West China Hospital
OTHER
Institute of Hematology & Blood Diseases Hospital, China
OTHER
Tianjin First Central Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
The First People's Hospital of Yunnan
OTHER
Beijing Hospital
OTHER_GOV
Responsible Party
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Yongjing Cheng
Professor
Principal Investigators
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Xuan Zhang, MD.
Role: STUDY_CHAIR
Beijing Hospital
Yongjing Cheng, MD.
Role: STUDY_CHAIR
Beijing Hospital
Shengqian Xu, MD.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Anhui Medical Hospital
Zhu Chen, MD.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Jing He, MD.
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Rong Mu, MD.
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Niansheng Yang, MD.
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Yang Li, MD.
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Guanmin Gao, MD.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Anbin Huang, MD.
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Fen Li, MD.
Role: PRINCIPAL_INVESTIGATOR
Second Xiangya Hospital of Central South University
Hui Luo, MD.
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Hongbin Li, MD.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Inner Mongolia Medical University
Pinting Yang, MD.
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Hongsheng Sun, MD.
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincial Hospital
Dongbao Zhao, MD.
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Sheng Chen, MD.
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Liyun Zhang, MD.
Role: PRINCIPAL_INVESTIGATOR
Shanxi Bethune Hospital
Qibing Xie, MD.
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Lei Zhang, MD.
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Wufang Qi, MD.
Role: PRINCIPAL_INVESTIGATOR
Tianjin First Central Hospital
Wei Wei, MD.
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University General Hospital
Lijun Wu, MD.
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Xinjiang Uygur Autonomous Region
Qin Li, MD.
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Yunnan
Locations
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The First Affiliated Hospital of Anhui Medical College
Hefei, Anhui, China
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Union Hospital, China
Wuhan, Hubei, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
RenJi Hospital
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
West China Hospital
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, China
The First People's Hospital of Yunnan
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Shengqian Xu, MD.
Role: primary
Zhu Chen, MD.
Role: primary
Xuan Zhang, MD.
Role: primary
Yongjing Cheng, MD.
Role: backup
Jing He, MD.
Role: primary
Rong Mu
Role: primary
Niansheng Yang, MD.
Role: primary
Yang Li, MD.
Role: primary
Anbin Huang, MD.
Role: primary
Fen Li, MD.
Role: primary
Hui Luo, MD.
Role: primary
Hongbin Li, MD.
Role: primary
Pinting Yang, MD.
Role: primary
Hongsheng Sun, MD.
Role: primary
Dongbao Zhao, MD.
Role: primary
Sheng Chen, MD.
Role: primary
Liyun Zhang, MD.
Role: primary
Qibing Xie, MD.
Role: primary
Lei Zhang, MD.
Role: primary
Wufang Qi, MD.
Role: primary
Wei Wei, MD.
Role: primary
Lijun Wu, MD.
Role: primary
Qin Li, MD.
Role: primary
Other Identifiers
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BJ-2021-235
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RCTAIIRCTD001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BJ-2021-235
Identifier Type: -
Identifier Source: org_study_id
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