drugset / Trial / NCT05504187

Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

NCT05504187 ↗

Phase 2 Not yet recruiting 24 enrolled Kira Pharmacenticals (US), LLC.
Non-randomizedSequentialOpen-labelTreatment

Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KP104 in participants with systemic lupus erythematosus (SLE)-Thrombotic microangiopathy (TMA). The study consists of 2 parts: Part 1 (Dose Optimization) and Part 2 (Proof of Concept). All participants will receive KP104 in combination with standard of care (SOC) for SLE-TMA.

Timeline

Start
2025-03
Primary completion
2026-03
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject VENSOBAFUSP ALFA Protein / enzyme biologic — —