Budoprutug: Single IV dose of study product on Day 1 of study
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events (TEAEs) — Up to Week 24 Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Incidence of Clinical Laboratory Abnormalities — Up to Week 24 Number of participants with clinically significant laboratory abnormalities.
Change from Baseline in Systolic Blood Pressure — Up to Week 24 Mean change from baseline in systolic blood pressure (mmHg).
Change from Baseline in Diastolic Blood Pressure — Up to Week 24 Mean change from baseline in diastolic blood pressure (mmHg).
Change from Baseline in Heart Rate — Up to Week 24 Mean change from baseline in heart rate (bpm).
Change from Baseline in Respiratory Rate — Up to Week 24 Mean change from baseline in respiratory rate.
Change from Baseline in Body Temperature — Up to Week 24 Mean change from baseline in body temperature (°C).
Change from Baseline in PR Interval — Up to Week 24 Mean change from baseline in PR interval (ms).
Change from Baseline in QRS Duration — Up to Week 24 Mean change from baseline in QRS duration (ms).
Change from Baseline in QT Interval — Up to Week 24 Mean change from baseline in QT interval (ms).
Change from Baseline in QTc Interval — Up to Week 24 Mean change from baseline in corrected QT interval (QTc).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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