Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KP104.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
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.
Interventions
- Drug KP104
KP104 will be administered.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05504187 · KP104-202