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

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kira Pharmacenticals (US), LLC.

Criteria

Inclusion Criteria:

• Meets criteria for SLE per the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria.

• Decrease in platelet count to less than (<)100,000/microliters (mcL).

• Abnormal renal function.

• Females of childbearing potential with negative pregnancy test and males must agree to practice effective contraception from Screening until 28 days after the End of study (EOS) visit.

• Willing and able to provide informed consent.

• Evidence of microangiopathic hemolytic anemia

Exclusion Criteria:

• Diagnosis of other TMA syndromes.

• A renal biopsy within 7 days of screening that shows exclusively chronic changes of TMA.

• Positive Coombs test at the time of TMA diagnosis.

• Positive nasopharyngeal swab for Neisseria meningitidis at Screening or a prior history of meningitis.

Only key inclusion and exclusion criteria have been included.