A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects with Immune Thrombocytopenia (ITP)

Conditions

Immune Thrombocytopenia (ITP)

Brief summary

1. Incidence, relatedness, severity, and duration of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs).

Detailed description

1. Budoprutug PK parameters (including area under the concentration-time curve, time to maximum observed concentration, terminal half-life, apparent clearance, and volume of distribution)., 2. The change from baseline in absolute peripheral cluster of differentiation (CD)20+ B-cell count., 3. The change in platelet count observed with budoprutug over time in subjects with ITP., 4. The percentage of subjects with ITP who achieve a stable, partial, and complete response by Week 12. Note: A stable, partial, and complete response is defined as a platelet count ≥ 30,000/μL, ≥ 50,000/μL, or ≥ 100,000/μL, respectively, on at least 2 occasions at least 7 days apart within a 30-day time frame., 5. The change in serum IgG, IgM, and IgA from baseline over time., 6. The incidence of subjects who develop ADAs at any time after study drug administration., 7. The percentage of subjects on a steroid at baseline who are able to stop steroid treatment.

Related papers

No related papers found yet.

Interventions

DRUGBudoprutug

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence, relatedness, severity, and duration of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs).	—

Secondary

Measure	Time frame
1. Budoprutug PK parameters (including area under the concentration-time curve, time to maximum observed concentration, terminal half-life, apparent clearance, and volume of distribution)., 2. The change from baseline in absolute peripheral cluster of differentiation (CD)20+ B-cell count., 3. The change in platelet count observed with budoprutug over time in subjects with ITP., 4. The percentage of subjects with ITP who achieve a stable, partial, and complete response by Week 12. Note: A stable, partial, and complete response is defined as a platelet count ≥ 30,000/μL, ≥ 50,000/μL, or ≥ 100,000/μL, respectively, on at least 2 occasions at least 7 days apart within a 30-day time frame., 5. The change in serum IgG, IgM, and IgA from baseline over time., 6. The incidence of subjects who develop ADAs at any time after study drug administration., 7. The percentage of subjects on a steroid at baseline who are able to stop steroid treatment.	—

Measure

Time frame

1. Budoprutug PK parameters (including area under the concentration-time curve, time to maximum observed concentration, terminal half-life, apparent clearance, and volume of distribution)., 2. The change from baseline in absolute peripheral cluster of differentiation (CD)20+ B-cell count., 3. The change in platelet count observed with budoprutug over time in subjects with ITP., 4. The percentage of subjects with ITP who achieve a stable, partial, and complete response by Week 12. Note: A stable, partial, and complete response is defined as a platelet count ≥ 30,000/μL, ≥ 50,000/μL, or ≥ 100,000/μL, respectively, on at least 2 occasions at least 7 days apart within a 30-day time frame., 5. The change in serum IgG, IgM, and IgA from baseline over time., 6. The incidence of subjects who develop ADAs at any time after study drug administration., 7. The percentage of subjects on a steroid at baseline who are able to stop steroid treatment.

—

Countries

Bulgaria, Greece, Spain

Outcome results

None listed