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The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
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, sequential-cohort, dose escalation and expansion study will evaluate the safety, tolerability, PK, PD, and preliminary clinical effectiveness of budoprutug in subjects with ITP. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts of patients aged 18 years and above with a platelet count < 30,000/µL despite an adequate trial of at least one prior therapeutic attempt.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose Level A | Experimental | Single IV dose of study product on Day 1 and on Day 15 |
|
| Cohort 2: Dose Level B | Experimental | Single IV dose of study product on Day 1 and on Day 15 |
|
| Cohort 3: Dose Level C | Experimental | Single IV dose of study product on Day 1 and on Day 15 |
|
| Dose Expansion Cohort | Experimental | Single IV dose of study product on Day 1 and Day 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budoprutug | Drug | Single IV dose of study product on Day 1 and Day 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0. | Up to week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) | Measurement of the area under the drug concentration-time curve. | Up to week 48 |
| Maximum Observed Plasma Concentration (Cmax) | Measurement of the maximum observed plasma concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Climb Bio Study Director | Contact | +1 866 857 2596 | clinicaltrials@climbbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Climb Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Climb Bio Investigative Site #359202 | Recruiting | Plovdiv | 4002 | Bulgaria | ||
| Climb Bio Investigative Site #359203 |
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This is an open-label study in which subjects will be enrolled into three dose ascending cohorts. Each subject's participation will last approximately 51 weeks including the Screening and Qualifying Visits (up to 3 weeks), Treatment Period (2 weeks), and follow-up visits though Week 48. Following completion of the dose escalation phase, additional subjects will be enrolled into an expansion cohort at the selected dose level(s) identified in Part 1b.
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|
| Up to week 48 |
| Time to Maximum Observed Concentration (Tmax) | Measurement of the time to maximum observed concentration. | Up to week 48 |
| Terminal Half-Life (T1/2) | Measurement of the terminal half-life in days. | Up to week 48 |
| Apparent Clearance (CL/F) | Measurement of the apparent clearance in L/hour. | Up to week 48 |
| Change from Baseline in CD20+ B-cell Count | Change in absolute peripheral CD20+ B-cell count | Up to week 48 |
| Change in Platelet Count | Change in platelet count over time | Up to week 48 |
| Proportion of Participants with stable, partial or complete platelet response | Percentage of participants with stable, partial or complete platelet response. | Up to week 48 |
| Incidence of Anti-Drug Antibodies (ADAs) | Number of participants with detectable ADAs. | Up to week 48 |
| Steroid Discontinuation Rate | % of baseline steroid users who discontinue steroids. | Up to week 48 |
| Recruiting |
| Plovdiv |
| 4003 |
| Bulgaria |
| Climb Bio Investigative Site #359201 | Recruiting | Sofia | 1797 | Bulgaria |
| Climb Bio Investigative Site #300204 | Recruiting | Athens | Attica | 11527 | Greece |
| Climb Bio Investigative Site #300203 | Recruiting | Chaïdári | Attica | 12462 | Greece |
| Climb Bio Investigative Site #300202 | Recruiting | Ioannina | 45500 | Greece |
| Climb Bio Investigative Site #300201 | Recruiting | Thessaloniki | 57010 | Greece |
| Climb Bio Investigative Site #381201 | Recruiting | Belgrade | Serbia |
| Climb Bio Investigative Site #381202 | Recruiting | Belgrade | Serbia |
| Climb Bio Investigative Site #381203 | Recruiting | Novi Sad | Serbia |
| Climb Bio Investigative Site #340206 | Not yet recruiting | Burgos | 9006 | Spain |
| Climb Bio Investigative Site #340204 | Recruiting | Madrid | 28041 | Spain |
| Climb Bio Investigative Site #340202 | Recruiting | San Pedro | Spain |
| Climb Bio Investigative Site #340203 | Recruiting | Valencia | 46010 | Spain |
| Climb Bio Investigative Site #380208 | Not yet recruiting | Cherkasy | Ukraine |
| Climb Investigative Site #380204 | Recruiting | Ivano-Frankivsk | Ukraine |
| Climb Investigative Site #2380203 | Recruiting | Kyiv | Ukraine |
| Climb Investigative Site #380202 | Recruiting | Kyiv | Ukraine |
| Climb Investigative Site #380206 | Recruiting | Kyiv | Ukraine |
| Climb Investigative Site #380201 | Recruiting | Lviv | Ukraine |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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