Systemic Lupus Erthematosus
Conditions
Keywords
Lupus, SLE, Biologics, Open-label, Monoclonal, anti-CD19
Brief summary
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.
Interventions
DRUGBudoprutug
Single IV dose of study product on Day 1 and Day 15
Sponsors
Climb Bio, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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 \>=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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Up to week 28 | Number of participants experiencing TEAEs, graded per NCI CTCAE v6.0. |
| Incidence of Clinical Laboratory Abnormalities | Up to week 28 | Number of participants with clinically significant laboratory abnomalities. |
| Incidence of dose-limiting toxicities (DLTs) | up to 28 weeks | Number of incidences of dose-limiting toxicities (DLTs) |
| Change from Baseline in Systolic Blood Pressure | Up to week 28 | Mean change from baseline in diastolic blood pressure (mmHg). |
| Change from Baseline in Diastolic Blood Pressure | up to 28 weeks | Mean change from baseline in systolic blood pressure (mmHg). |
| Change from Baseline in Heart Rate | up to 28 weeks | Mean change from baseline in heart rate (bpm). |
| Change from Baseline in Respiratory Rate | up to 28 weeks | Mean change from baseline in respiratory rate |
| Change from Baseline in Body Temperature | up to 28 weeks | Mean change from baseline in body temperature (°C) |
| Change from Baseline in PR Interval | up to 28 weeks | Mean change from baseline in PR interval (ms) |
| Change from Baseline in QRS Duration | up to 28 weeks | Mean change from baseline in QRS duration (ms) |
| Change from Baseline in QT Interval | up to 28 weeks | Mean change from baseline in QT interval (ms) |
| Change from Baseline in QTc Interval | up to 28 weeks | Mean change from baseline in corrected QT interval (QTc) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) | Up to week 28 | Measurement of the area under the drug concentration-time curve |
| Terminal Half-Life (T1/2) | Up to week 28 | Measurement of the terminal half-life in days |
| Incidence of Anti-Drug Antibodies (ADAs) | Up to week 28 | Number of participants with detectable ADAs. |
| ADA Titer Over Time | Up to week 28 | Measurement of ADA titer over time |
| Change from Baseline in CD20+ B-cell Count | Up to week 28 | Change in absolute peripheral B-cell count |
| Change from Baseline in SLEDAI-2K Score | up to 28 weeks | Measurement of change in SLEDAI-2K score from baseline |
| Change from Baseline in Urine Protein Creatinine Ratio (UPCR) | up to 28 weeks | Measurement of change in UPCR from baseline |
Countries
China
Contacts
CONTACTClimb Bio Study Director
STUDY_DIRECTORStudy Director
Climb Bio, Inc.
Outcome results
None listed