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

NCT ID: NCT05504187

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-04-30

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Dose Optimization Cohort 1, Dose 1

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

Group Type: EXPERIMENTAL

KP104

Intervention Type: DRUG

KP104 will be administered.

Part 1: Dose Optimization Cohort 2, Dose 2

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.

Group Type: EXPERIMENTAL

KP104

Intervention Type: DRUG

KP104 will be administered.

Part 1: Dose Optimization Cohort 3, Dose 3

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.

Group Type: EXPERIMENTAL

KP104

Intervention Type: DRUG

KP104 will be administered.

Part 2: OBD Cohort, Dose 4

Participants will be administered with KP104 OBD for 24 Weeks.

Group Type: EXPERIMENTAL

KP104

Intervention Type: DRUG

KP104 will be administered.

Interventions

KP104

KP104 will be administered.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kira Pharmacenticals (US), LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Study Director

Role: CONTACT

privacy@kirapharma.com

Other Identifiers

KP104-202

Identifier Type: -

Identifier Source: org_study_id