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

ConditionSystemic Lupus Erythematosus

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorClimb Bio, Inc.

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.