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

Kira Pharmacenticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: KP104

Study type: Interventional

Funder types: Industry

Identifiers

NCT05504187

KP104-202

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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 exclusion criteria have been included.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Part 1: Dose Optimization Cohort 1, Dose 1

Experimental group

Description:

Participants will be administered with KP104 as a weekly maintenance dose for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by the Internal Data Review Committee (IDRC) to determine Dosing Regimen 2

Treatment:

Drug: KP104

Part 1: Dose Optimization Cohort 2, Dose 2

Experimental group

Description:

Participants will be administered with KP104 dose regimen 2 for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by the IDRC to determine Dosing Regimen 3.

Treatment:

Drug: KP104

Part 1: Dose Optimization Cohort 3, Dose 3

Experimental group

Description:

Participants will be administered with KP104 dose regimen 3 for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by IDRC to determine the Optimal biologic dose (OBD) for Part 2.

Treatment:

Drug: KP104

Part 2: OBD Cohort, Dose 4

Experimental group

Description:

Participants will be administered with KP104 OBD for 24 Weeks.

Treatment:

Drug: KP104