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New treatment option for Systemic Lupus Erythematosus
Official title A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT07011043
What this study is testing
What is Budoprutug?
Budoprutug is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as TNT119.
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 main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Phase 1: an early, usually small safety study
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 65
You may be able to join if
- Aged 18 to 65 years at the time of consent.
- Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
- Active, seropositive disease, with SLEDAI 2K \>=8.
- Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.
You likely can't join if
- Active neuropsychiatric SLE.
- History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory...
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
The study team makes the final eligibility decision.
Where it's taking place
- Allen, Texas, United States
- San Antonio, Texas, United States
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Tbilisi, Georgia
- Exochi, Thessaloniki, Greece
- Thessaloniki, Thessaloniki, Greece
- Caguas, Puerto Rico
- Cluj-Napoca, Romania
- Sabadell, Barcelona, Spain
- A Coruña, Spain
- Ivano-Frankivsk, Ukraine
- Kyiv, Ukraine
- Ternopil, Ukraine
- Vinnytsia, Ukraine
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Allen, Texas, United States; San Antonio, Texas, United States; Plovdiv, Bulgaria; Sofia, Bulgaria; Tbilisi, Georgia; Exochi, Thessaloniki, Greece 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.