Tests budoprutug, a new drug, in adults with lupus
Tests budoprutug's safety in adults aged 18 to 65 with systemic lupus erythematosus.
Plain-language title generated from the registry record
Registry title: A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Key facts
- Where
- Tbilisi, GeorgiaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active systemic lupus erythematosus (SLE) who did not respond well enough to earlier treatments.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Active, seropositive SLE with a SLEDAI 2K score of 8 or higher.
- Earlier treatment
- Not enough response to at least 2 treatments, including at least one oral immunosuppressive or biologic standard-of-care therapy.
- Biomarker or test result
- Seropositive disease.
Main reasons for not taking part
- Active neuropsychiatric SLE
- History of other inflammatory or autoimmune diseases that need immune suppressive therapy (stable Sjogren's, asthma or autoimmune thyroid disease may be considered)
- Active systemic infection
- History of chronic, recurrent, latent or recent serious infections
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07011043, who can take part
Where in Georgia
- TbilisiHospital not named in the registryContact: Climb Bio Study DirectorTaking people
- TbilisiHospital not named in the registryContact: Climb Bio Study DirectorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Climb Bio, Inc.
- Trial code
- NCT07011043
- Record updated
- 27 March 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; Active neuropsychiatric SLE.