Not Yet RecruitingPhase 2

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

24 participantsStarted 2025-03

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

Timeframe: Up to 24 weeks

Part 2: Percent change from Baseline in platelet count

Timeframe: Baseline (Day 1) and up to Week 12

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

Timeframe: Baseline (Day 1) and up to Week 12

Trial details

NCT IDNCT05504187

SponsorKira Pharmacenticals (US), LLC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Study Director

privacy@kirapharma.com

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

Timeframe: Up to 24 weeks

Part 2: Percent change from Baseline in platelet count

Timeframe: Baseline (Day 1) and up to Week 12

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

Timeframe: Baseline (Day 1) and up to Week 12