Budoprutug infusion for adults with active, seropositive lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b, open-label, single-ascending-dose trial testing a single intravenous infusion of budoprutug in adults with active, seropositive systemic lupus erythematosus who have had an inadequate response to at least two prior therapies. The primary focus is safety and tolerability, with serial pharmacokinetic and pharmacodynamic measurements following dosing. Pharmacodynamics will be measured by changes in circulating B cells and immunoglobulin levels over time, and investigators will also look for early signs of clinical benefit. Dose-escalation cohorts will help characterize tolerability across increasing doses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Climb Bio Investigative Site #100104
  Allen, Texas, United States Recruiting
• Climb Bio Investigative Site #100101
  San Antonio, Texas, United States Recruiting
• Climb Bio Investigative Site# 359101
  Plovdiv, Bulgaria Recruiting
• Climb Bio Investigative Site# 359102
  Sofia, Bulgaria Recruiting
• Climb Bio Investigative Site #995102
  Tbilisi, Georgia Recruiting
• Climb Bio Investigative Site #995101
  Tbilisi, Georgia Recruiting

Study contacts

• Study coordinator: Climb Bio Study Director
• Email: clinicaltrials@climbbio.com
• Phone: +1 866 857 2596

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.