A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Recruiting · NCT07011043 · Interventional (participants receive a specific treatment) · Lead sponsor: Climb Bio, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Budoprutug
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Active neuropsychiatric SLE.
- History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation.
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
Where it is running
18 locations listed across 1 US state.
- Climb Bio Investigative Site #100104 - Allen, Texas, United States
- Climb Bio Investigative Site #100101 - San Antonio, Texas, United States
- Climb Bio Investigative Site# 340102 - A Coruña, Spain
- Climb Bio Investigative Site #100103 - Caguas, Puerto Rico
- Climb Bio Investigative Site# 400101 - Cluj-Napoca, Romania
- Climb Bio Investigative Site #380102 - Ivano-Frankivsk, Ukraine
- Climb Bio Investigative Site #380103 - Kyiv, Ukraine
- Climb Bio Investigative Site #380106 - Kyiv, Ukraine
- Climb Bio Investigative Site# 359101 - Plovdiv, Bulgaria
- Climb Bio Investigative Site# 359102 - Sofia, Bulgaria
- Climb Bio Investigative Site #995102 - Tbilisi, Georgia
- Climb Bio Investigative Site #995101 - Tbilisi, Georgia
- Climb Bio Investigative Site #380101 - Ternopil, Ukraine
- Climb Bio Investigative Site #380104 - Vinnytsia, Ukraine
- Climb Bio Investigative Site #380105 - Vinnytsia, Ukraine
- Climb Bio Investigative Site# 340101 - Sabadell, Barcelona, Spain
- Climb Bio Investigative Site# 300102 - Exochi, Thessaloniki, Greece
- Climb Bio Investigative Site# 300103 - Thessaloniki, Thessaloniki, Greece