A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)

Launched by CLIMB BIO, INC. · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called budoprutug for adults with systemic lupus erythematosus (SLE), a condition where the immune system attacks the body’s own tissues. The main goal of the trial is to find out if budoprutug is safe and how well it works for people who have not responded well to other treatments for their lupus. The trial is currently looking for participants aged 18 to 65 who have been diagnosed with SLE and have active symptoms despite trying at least two other treatments.

If you join the trial, you will be monitored closely to ensure your safety and to see how your body reacts to the medication. Participants will receive information about the study and what to expect throughout the process. It’s important to know that certain health conditions, such as active infections or other autoimmune diseases, may prevent you from participating. This study hopes to gather important information that could lead to better options for people living with lupus.

Gender

ALL

Eligibility criteria

• 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.