Budoprutug in systemic lupus erythematosus (SLE)

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 open-label, dose-escalation study will evaluate Budoprutug, a humanized anti-CD19 monoclonal antibody, in adults with active seropositive SLE. Participants will receive ascending doses of Budoprutug as two IV infusions 14 days apart, with pharmacokinetics, pharmacodynamics (changes in B cells and immunoglobulins), and early efficacy signals monitored. The trial focuses on safety, tolerability, and initial signs of clinical benefit in patients who have inadequate responses to standard treatments. Eligibility includes adults 18–65 with SLE confirmed by recognized criteria and active disease; certain neuropsychiatric or nephritic conditions are exclusionary. The study is sponsored by Climb Bio, Inc. and includes sites in China (Mianyang, Baoji, and Beijing).

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 \>=6 at screening
4. Inadequate response to at least one therapeutic intervention

Exclusion Criteria:

1. Active neuropsychiatric SLE.
2. Active lupus nephritis type III or IV that is expected to require induction therapy during the study or recently treated with induction therapy within 12 weeks.
3. Prior diagnosis of, or fulfills diagnostic criteria for, other autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
4. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

Where it's running

• Baoji Central Hospital
  Baoji, China Recruiting
• Peking University People's Hospital
  Beijing, China Recruiting
• Shanxi Bethune Hospital
  Taiyuan, China Recruiting
• Mianyang Central Hospital
  Mianyang, Sichuan, China Active not recruiting
• The First Affiliated Hospital of Bengbu Medical College
  Bengbu, China Not yet recruiting
• Xiangya Second Hospital of Central South University
  Changsha, China Not yet recruiting

Study contacts

• Study coordinator: Climb Bio Study Director
• Email: clinicaltrials@climbbio.com
• Phone: +1 8668572596

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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.