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New treatment option for Connective Tissue Diseases
Official title Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
ClinicalTrials.gov ID: NCT05998759
What this study is testing
What is Telitacicept?
Telitacicept is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for connective tissue diseases.
Also referred to as recombinant human B lymphocyte stimulating factor receptor-Fc fusion protein, Recombinant Human B Lymphocyte(RC18).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people who have been diagnosed with connective tissue disease (CTD)-associated thrombocytopenia. And CTD includes primary Sjögren syndrome (according...
- Refractory thrombocytopenia defined as: Either: Failure to maintain sustained remission after treatment by glucocorticoid and at least one...
- 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...
You likely can't join if
- Vital organ lethal bleeding (including but not limited to central nervous system bleeding, digestive tract bleeding) at screening, or intracranial...
- Antiphospholipid syndrome, thrombotic thrombocytopenia purpura, hemolytic uremic syndrome, or thrombocytopenia secondary to other causes (such as...
- Hematopoietic system disorders, such as myelodysplastic syndrome, paroxysmal sleep hemoglobinuria, aplastic anemia, leukemia, lymphoma, myelofibrosis...
- Severe cardiovascular system disease, including: unstable or uncontrollable disease or condition affecting the function of the heart (such as angina...
- Arteriovenous thromboembolism events
- Receiving antiplatelet or anticoagulant therapy at screening
See the full eligibility criteria
- people who have been diagnosed with connective tissue disease (CTD)-associated thrombocytopenia. And CTD includes primary Sjögren syndrome (according to the 2002 American College of Rheumatology (ACR)/ European League...
- 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...
- 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)...
- Signed informed consent form, willing or able to participate in all required study evaluations and procedures
- Vital organ lethal bleeding (including but not limited to central nervous system bleeding, digestive tract bleeding) at screening, or intracranial bleeding 6 months prior to screening
- Antiphospholipid syndrome, thrombotic thrombocytopenia purpura, hemolytic uremic syndrome, or thrombocytopenia secondary to other causes (such as sepsis, Epstein-Barr virus infection, cytomegalovirus infection, Corona...
- 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...
- 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...
- 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...
- 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...
- Active hepatitis, a history of severe liver disease. people positive for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus are excluded. As for people with antibodies to hepatitis B core antigen...
- 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)
- people with known active infections (e.g., shingles, COVID-19, HIV, active tuberculosis, etc.), and active or recurrent gastrointestinal ulcers
- Pregnant or lactating women, and people 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hohhot, Inner Mongolia, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Ürümqi, Xinjiang Uygur Autonomous Region, China
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Changsha, Hunan, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.