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

Last updated: October 25, 2024
Sponsor: Kira Pharmacenticals (US), LLC.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Bone Diseases

Treatment

KP104

Clinical Study ID

NCT05504187
KP104-202
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 (<)150,000/microliters (mcL).

  • Abnormal renal function.

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

  • Willing and able to provide informed consent.

  • Evidence of microangiopathic hemolytic anemia

Exclusion

Exclusion Criteria:

  • Diagnosis of other TMA syndromes.

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

  • Positive Coombs test at the time of TMA diagnosis.

  • Active or unresolved Neisseria meningitidis infection at screening.

Only key inclusion and exclusion criteria have been included.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: KP104
Phase: 2
Study Start date:
March 01, 2025
Estimated Completion Date:
April 30, 2027