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NCT Number: NCT05504187

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Blood Platelet Disorders Connective Tissue Diseases Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.
  • Active or unresolved Neisseria meningitidis infection at screening.

Only key inclusion and exclusion criteria have been included.

Treatment and study plan

KP104

Drug

KP104 will be administered.

Primary outcomes

  1. Parts 1 and 2: Number of participants with Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESIs)

    Time frame: Up to 24 weeks

  2. Part 2: Percent change from Baseline in platelet count

    Time frame: Baseline (Day 1) and up to Week 12

  3. Part 2: Percent change from Baseline in serum lactate dehydrogenase (LDH) levels

    Time frame: Baseline (Day 1) and up to Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Kira Pharmacenticals (US), LLC.

Industry

Registry information

Official study title

An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Subjects With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 17, 2022
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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