Systemic Lupus Erythematosus study: Budoprutug
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?
An investigational intravenous medicine being studied for systemic lupus erythematosus. is designed to bind CD19 on B cells and trigger their removal from the body.
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 study aims to see if budoprutug is safe and tolerable in people with SLE, and to look at how the drug behaves in the body and any early signs of benefit.
- Who it's for
- Adults who have been diagnosed with systemic lupus erythematosus.
- What's involved
- Participants will receive budoprutug and have blood tests and other measurements to check safety and drug levels.
- Time commitment
- The study lasts a few weeks to months, with several clinic visits for dosing and monitoring.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Allen, Texas, United States; San Antonio, Texas, United States; Plovdiv, Bulgaria; Sofia, Bulgaria; Tbilisi, Georgia; Exochi, Thessaloniki, Greece and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.