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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose Level A | Experimental | Single IV dose at Day 1 and Day 15 |
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| Cohort 2: Dose Level B | Experimental | Single IV dose at Day 1 and Day 15 |
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| Cohort 3: Dose Level C | Experimental | Single IV dose at Day 1 and Day 15 |
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| Dose Expansion Cohort | Experimental | Single IV dose at Day 1 and Day 15 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budoprutug | Drug | Single IV dose of study product on Day 1 and Day 15 |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Number of participants experiencing TEAEs, graded per NCI CTCAE v6.0. | Up to week 28 |
| Incidence of Clinical Laboratory Abnormalities | Number of participants with clinically significant laboratory abnomalities. | Up to week 28 |
| Incidence of dose-limiting toxicities (DLTs) | Number of incidences of dose-limiting toxicities (DLTs) | up to 28 weeks |
| Change from Baseline in Systolic Blood Pressure | Mean change from baseline in diastolic blood pressure (mmHg). | Up to week 28 |
| Change from Baseline in Diastolic Blood Pressure | Mean change from baseline in systolic blood pressure (mmHg). | up to 28 weeks |
| Change from Baseline in Heart Rate | Mean change from baseline in heart rate (bpm). | up to 28 weeks |
| Change from Baseline in Respiratory Rate | Mean change from baseline in respiratory rate | up to 28 weeks |
| Change from Baseline in Body Temperature | Mean change from baseline in body temperature (°C) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) | Measurement of the area under the drug concentration-time curve | Up to week 28 |
| Terminal Half-Life (T1/2) | Measurement of the terminal half-life in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Climb Bio Study Director | Contact | +1 8668572596 | clinicaltrials@climbbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Climb Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
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| up to 28 weeks |
| Change from Baseline in PR Interval | Mean change from baseline in PR interval (ms) | up to 28 weeks |
| Change from Baseline in QRS Duration | Mean change from baseline in QRS duration (ms) | up to 28 weeks |
| Change from Baseline in QT Interval | Mean change from baseline in QT interval (ms) | up to 28 weeks |
| Change from Baseline in QTc Interval | Mean change from baseline in corrected QT interval (QTc) | up to 28 weeks |
| Up to week 28 |
| Incidence of Anti-Drug Antibodies (ADAs) | Number of participants with detectable ADAs. | Up to week 28 |
| ADA Titer Over Time | Measurement of ADA titer over time | Up to week 28 |
| Change from Baseline in CD20+ B-cell Count | Change in absolute peripheral B-cell count | Up to week 28 |
| Change from Baseline in SLEDAI-2K Score | Measurement of change in SLEDAI-2K score from baseline | up to 28 weeks |
| Change from Baseline in Urine Protein Creatinine Ratio (UPCR) | Measurement of change in UPCR from baseline | up to 28 weeks |