A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
ConditionSystemic Lupus Erthematosus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorClimb Bio, Inc.
About this trial
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 >=6 at screening
Inadequate response to at least one therapeutic intervention
Disqualifiers
Active neuropsychiatric SLE.
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.
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
Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
Trial design
Design model
Sequential
Treatments tested in this trial
Budoprutug
DrugSingle IV dose of study product on Day 1 and Day 15
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: Cohort 1: Dose Level AExperimental treatment 1 intervention
Group B: Cohort 2: Dose Level BExperimental treatment 1 intervention
Group C: Cohort 3: Dose Level CExperimental treatment 1 intervention
Group D: Dose Expansion CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing TEAEs, graded per NCI CTCAE v6.0.
Time frame
Up to week 282
Incidence of Clinical Laboratory Abnormalities
Number of participants with clinically significant laboratory abnomalities.
Time frame
Up to week 283
Incidence of dose-limiting toxicities (DLTs)
Number of incidences of dose-limiting toxicities (DLTs)
Time frame
up to 28 weeks4
Change from Baseline in Systolic Blood Pressure
Mean change from baseline in diastolic blood pressure (mmHg).
Time frame
Up to week 28Secondary outcomes
1
Area Under the Curve (AUC)
Measurement of the area under the drug concentration-time curve
Time frame
Up to week 282
Terminal Half-Life (T1/2)
Measurement of the terminal half-life in days
Time frame
Up to week 283
Incidence of Anti-Drug Antibodies (ADAs)
Number of participants with detectable ADAs.
Time frame
Up to week 284
ADA Titer Over Time
Measurement of ADA titer over time
Time frame
Up to week 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov