A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Climb Bio, Inc. · NCT07011043
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 30
- US sites recruiting
- 2
- Study start
- July 10, 2025
- Record last updated
- March 27, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Budoprutug
Conditions: Systemic Lupus Erythematosus
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Climb Bio Investigative Site #100104
Allen, TX 75013
Climb Bio Investigative Site #100101
San Antonio, TX 78215
Study contacts (from the official record)
- Climb Bio Study Director · +1 866 857 2596 · clinicaltrials@climbbio.com
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