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

A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This Phase 1b, open-label study will evaluate budoprutug administered as a single intravenous infusion in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of budoprutug and how well adults with systemic lupus erythematosus (SLE), or lupus, tolerate it. It also looks at how the body handles the drug, its effects on the body, and early signs that it may help. It is for adults with active lupus that has not responded well enough to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 65 years old when you agree to join.
  • Have lupus diagnosed using the 2019 EULAR/ACR medical standards.
  • Have active lupus with positive blood tests for lupus-related antibodies and a disease activity score (SLEDAI-2K) of at least 8.
  • Have not improved enough with at least 2 treatments, including at least one standard immune-suppressing pill or biologic medicine (a medicine made from living cells).

Who can't join

  • Have active lupus affecting the brain, nerves, or mental health.
  • Have a history of other diseases involving inflammation or the immune system attacking the body, such as rheumatoid arthritis, scleroderma, myositis, vasculitis, or inflammatory bowel disease, or other conditions needing immune-suppressing treatment. People with stable Sjogren's disease, asthma, or autoimmune thyroid disease may still be considered.
  • Have an active infection throughout the body, or a history of long-lasting, repeated, dormant (inactive), or recent serious infections.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

TX