Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Longbio Pharma

Status and phase: Not yet enrolling; Phase 2

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Treatments: Biological: LP-005 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07266155

P10-LP005-05

Details and patient eligibility

About

This is an extension study for patients who have completed a prior P10-LP005-02 clinical study. The aim of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of LP-005 injection in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients have fully understood the trial, have voluntarily agreed to participate in this clinical trial, and have signed a written Informed Consent Form (ICF).
2. Patients who have completed the treatment of the Phase Ⅱ clinical study of LP-005 Injection and are assessed by the investigator as eligible for continued treatment with LP-005 Injection.
3. Patients who have received Neisseria meningitidis vaccine and Streptococcus pneumoniae vaccine in accordance with the requirements of previous studies; if the vaccine protection period does not cover the treatment duration of this study, patients must agree to receive booster vaccination in a timely manner in accordance with the vaccine administration guidelines and the requirements of local vaccination institutions.
4. Females and males of childbearing potential (including male subjects with female partners) must agree to use effective contraceptive measures from the start of the trial until 3 months after the end of the trial.

Exclusion criteria

1. Patients who have not completed the treatment of the Phase II clinical trial (P10-LP005-02) of the study drug.
2. Patients who have completed the Phase II treatment phase but are unwilling to continue receiving the study drug treatment.
3. Patients for whom the investigator does not recommend the continued use of LP-005 Injection after comprehensive assessment.
4. Patients who did not participate in the Phase II clinical trial (P10-LP005-02) of the study drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

LP-005 1200 mg

Experimental group

Description:

Patients will receive intravenous infusion of LP-005 Injection at a dose of 1200 mg once every 4 weeks.

Treatment:

Biological: LP-005 Injection

LP-005 1500 mg

Experimental group

Description:

Patients will receive intravenous infusion of LP-005 Injection at a dose of 1500 mg once every 4 weeks.

Treatment:

Biological: LP-005 Injection