NCT07011043RecruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 May 2025
- Start date
- 10 Jul 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Climb Bio, Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT07011043
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 10 Jul 2025 to the primary completion date, Apr 2027
- 18 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
Other
- Active neuropsychiatric SLE.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.