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ACTIVE NOT RECRUITING
NCT05476887
PHASE2

To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104

Sponsor: Kira Pharmacenticals (US), LLC.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of KP104 in complement inhibitor-naïve participants with PNH. The study will be conducted in 2 parts. Part 1 is a dose-selection study to assess escalating doses and varying dose intervals of KP104. Part 2 is a proof-of-concept (POC) study assessing the efficacy of the optimal intravenous (IV) loading dose followed by the optimal maintenance dose and regimen of KP104. Participants who complete the Initial Treatment Period and demonstrate benefit from KP104 will be eligible for a 9-month open-label extension (OLE) treatment period.

Official title: An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Complement Inhibitor-naïve Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2022-11-25

Completion Date

2025-02

Last Updated

2024-10-28

Healthy Volunteers

No

Interventions

DRUG

KP104

KP104 intravenously (IV loading + subcutaneous \[SC\] maintenance every week \[QW\] or every 2 weeks \[Q2W\]) will be administered.

Locations (4)

Peking Union Medical College Hospital

Beijing, China

Jiangsu Province Hospital

Nanjing, China

Chinese Academy of Medical Sciences Peking Union Medical College - Institute of Hematology Blood Diseases Hospital

Tianjin, China

Henan Cancer Hospital

Zhengzhou, China