Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
budoprutug · 5 trials · 9 indications
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Number of participants with clinically significant laboratory abnomalities.
Number of incidences of dose-limiting toxicities (DLTs)
Mean change from baseline in diastolic blood pressure (mmHg).
Mean change from baseline in systolic blood pressure (mmHg).
Mean change from baseline in heart rate (bpm).
Mean change from baseline in respiratory rate
Mean change from baseline in body temperature (°C)
Mean change from baseline in PR interval (ms)
Mean change from baseline in QRS duration (ms)
Mean change from baseline in QT interval (ms)
Mean change from baseline in corrected QT interval (QTc)
Incidence of treatment-emergent adverse events
Number of infusion-related reactions
Number of injection site reactions
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose Level A | EXPERIMENTAL | - |
| Cohort 2: Dose Level B | EXPERIMENTAL | - |
| Cohort 3: Dose Level C | EXPERIMENTAL | - |
| Dose Expansion Cohort | EXPERIMENTAL | Single IV dose at Day 1 and Day 15 |
| Cohort 4: Dose Level D | EXPERIMENTAL | - |
| Budoprutug | EXPERIMENTAL | Subcutaneous (SC) injection or IV administration of budoprutug |
| Placebo | PLACEBO_COMPARATOR | Placebo solution to be administered at a matching volume |
| Name | Type | Description |
|---|---|---|
| budoprutug | DRUG | Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183 |
| Placebo | DRUG | Placebo comparator |
Inclusion Criteria: * Confirmed diagnosis of PMN with positive anti-PLA2R antibodies * CD19+ B cell count ≥40 cells/μL * UPCR ≥2.0 g/g * eGFR ≥35 mL/min/1.73 m² * Stable RAAS inhibitor therapy * Blood pressure \<150/90 mmHg at baseline * Adequate hematologic, hepatic, and renal function * Willing t...
Budoprutug is an investigational small molecule being studied for systemic lupus erythematosus (SLE), primary membranous nephropathy, immune thrombocytopenia (ITP), and in healthy volunteers. It is in clinical development by Climb Bio, Inc. and is not yet approved by the FDA.
Budoprutug is a monoclonal antibody that targets CD19, as indicated in the trial for immune thrombocytopenia. It is being studied for its potential to modulate B-cell activity in autoimmune conditions.
Budoprutug is being developed by Climb Bio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol CLYM. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Budoprutug is in Phase 1 and Phase 2 clinical trials. It has completed an early Phase 1 study in healthy volunteers and is currently recruiting for Phase 1b studies in SLE and ITP, as well as a Phase 2 study in primary membranous nephropathy.
Budoprutug is being studied in several trials: NCT07011043 (Phase 1b in SLE), NCT07043946 (Phase 1b/2a in ITP), NCT07090655 (completed Phase 1 in healthy volunteers), and NCT07096843 (Phase 2 in primary membranous nephropathy). All are actively recruiting except the healthy volunteer study.
Yes, Budoprutug is also known as TNT119. In a completed Phase 1 study in healthy volunteers, the drug was referred to as Budoprutug (TNT119), confirming that both names refer to the same investigational agent.