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New treatment option for Childhood-onset Systemic Lupus Erythematous
Official title Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
ClinicalTrials.gov ID: NCT07089121
What this study is testing
What is Descartes-08?
Descartes-08 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for childhood-onset systemic lupus erythematous.
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
- Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- At least age 12
- definitive diagnosis of childhood-onset systemic lupus erythematous, juvenile Myasthenie gravis, juvenile dermatomyositis and AAV
- Signs and symptoms of moderate disease
- History of systemic treatment
- Parent/Guardian/Patient must be able to give written informed consent
You likely can't join if
- Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient;
- Abnormal PT/INR or PTT increased \> 1.5-fold or patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus...
- ANC \< 1000 cells/microliter ;
- Hemoglobin \< 8.0 g/dL ;
- Platelets \< 50,000/mm3 (NOTE: platelet transfusions are permissible);
- ALT and/or AST with GGT ≥ 3× upper limit of normal
See the full eligibility criteria
- At least age 12
- definitive diagnosis of childhood-onset systemic lupus erythematous, juvenile Myasthenie gravis, juvenile dermatomyositis and AAV
- Signs and symptoms of moderate disease
- History of systemic treatment
- Parent/Guardian/Patient must be able to give written informed consent
- Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient;
- Abnormal PT/INR or PTT increased \> 1.5-fold or patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus anticoagulant; or in patients who have been on stable doses of anticoagulation...
- ANC \< 1000 cells/microliter ;
- Hemoglobin \< 8.0 g/dL ;
- Platelets \< 50,000/mm3 (NOTE: platelet transfusions are permissible);
- ALT and/or AST with GGT ≥ 3× upper limit of normal
- Creatine Clearance less than 30mL/min /1.73 m2;
- History of primary immunodeficiency, organ, or allogeneic bone marrow transplant;
- Patients must be seronegative for hepatitis B surface antigen;
- Patients must be seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patients must be tested for the presence of viremia by RT-PCR and must be HCV RNA negative;
- History of positive HIV or positive HIV at screening;
- Active tuberculosis or positive QuantiFERON test at screening;
- Any other laboratory abnormality that, in the opinion of the investigator, may jeopardize the subject's ability to participate in the study; 23. Any active significant cardiac or pulmonary disease not related to the...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- St Louis, Missouri, United States
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; St Louis, Missouri, United States. 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.