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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05504187

Enrollment

Registered

2022-08-17

Start date

2025-03-31

Completion date

2027-04-30

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus, Thrombotic microangiopathy, Dose Selection, Proof of Concept, KP-104

Brief 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.

Interventions

DRUGKP104

KP104 will be administered.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)	Up to 24 weeks
Part 2: Percent change from Baseline in platelet count	Baseline (Day 1) and up to Week 12
Part 2: Percent change from Baseline in serum lactate dehydrogenase (LDH) levels	Baseline (Day 1) and up to Week 12

Contacts

Primary ContactStudy Director

privacy@kirapharma.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026