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

Phase 2Not Yet RecruitingNCT05504187

Kira Pharmacenticals (US), LLC.24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

KP104DRUG

KP104 will be administered.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Part 2: Percent change from Baseline in platelet count

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

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

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

Central Contacts

Study Director

CONTACT

privacy@kirapharma.com

Data from ClinicalTrials.gov

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