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NCT05504187

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

StatusWithdrawn
PhasePhase 2
Primary completion (estimated)
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Record History

All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Withdrawn before enrolling Sponsor's reason: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns
    • Enrollment target: estimated 24 to confirmed 0
    • Eligibility criteria expanded, about 10 words
  2. Primary completion date: Oct 2024 to Mar 2026
    • Start date: Oct 2023 to Mar 2025
    • Study completion date: Oct 2024 to Apr 2027
    v4
  3. Primary and study completion dates: Oct 2023 to Oct 2024v3 Show 4 more changesShow less
    • Start date: Nov 2022 to Oct 2023
    • Eligibility criteria shortened, about 6 words
    • Primary endpoints: 2 to 3
    • Secondary endpoints shortened, about 44 words
  4. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed

Endpoints

Primary

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

Arms and interventions

Part 1: Dose Optimization Cohort 1, Dose 1Experimental

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 2Experimental

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 1: Dose Optimization Cohort 3, Dose 3Experimental

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.

Part 2: OBD Cohort, Dose 4Experimental

Participants will be administered with KP104 OBD for 24 Weeks.

Drugs: KP104