RECRUITINGPhase 1INTERVENTIONAL
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
1. Aged 18 to 65 years at the time of consent.
2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
3. Active, seropositive disease, with SLEDAI 2K \>=8.
4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.
Who Should NOT Join This Trial:
1. Active neuropsychiatric SLE.
2. History of inflammatory or autoimmune conditions (where your immune system attacks your own body)s 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.
3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Aged 18 to 65 years at the time of consent.
2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
3. Active, seropositive disease, with SLEDAI 2K \>=8.
4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.
Exclusion Criteria:
1. Active neuropsychiatric SLE.
2. 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.
3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
Treatments Being Tested
DRUG
Budoprutug
Single IV dose of study product on Day 1 of study
Locations (18)
Climb Bio Investigative Site #100104
Allen, Texas, United States
Climb Bio Investigative Site #100101
San Antonio, Texas, United States
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# 300102
Exochi, Thessaloniki, Greece
Climb Bio Investigative Site# 300103
Thessaloniki, Thessaloniki, Greece
Climb Bio Investigative Site #100103
Caguas, Puerto Rico
Climb Bio Investigative Site# 400101
Cluj-Napoca, Romania
Climb Bio Investigative Site# 340101
Sabadell, Barcelona, Spain
Climb Bio Investigative Site# 340102
A Coruña, Spain
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 #380101
Ternopil, Ukraine
Climb Bio Investigative Site #380104
Vinnytsia, Ukraine
Climb Bio Investigative Site #380105
Vinnytsia, Ukraine