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

Phase 2

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: KP104

• Registration Number: NCT05504187
• Lead Sponsor: Kira Pharmacenticals (US), LLC.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-28
• Study Start: 2025-03
• Primary Completion: 2026-03
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Dose Optimization Cohort 1, Dose 1	KP104	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
Part 1: Dose Optimization Cohort 2, Dose 2	KP104	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.
Part 2: OBD Cohort, Dose 4	KP104	Participants will be administered with KP104 OBD for 24 Weeks.
Part 1: Dose Optimization Cohort 3, Dose 3	KP104	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.

Primary Outcome Measures

Name	Time	Method
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)	Up to 24 weeks
Part 2: Percent change from Baseline in platelet count	Baseline (Day 1) and up to Week 12
Part 2: Percent change from Baseline in serum lactate dehydrogenase (LDH) levels	Baseline (Day 1) and up to Week 12