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

NCT ID: NCT07266155

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-05
• Study Completion Date: 2028-05-01

Brief Summary

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).

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Study Design

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

Study Groups

LP-005 1200 mg

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

Group Type: EXPERIMENTAL

LP-005 Injection

Intervention Type: BIOLOGICAL

IV infusion, Q4W

LP-005 1500 mg

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

Group Type: EXPERIMENTAL

LP-005 Injection

Intervention Type: BIOLOGICAL

IV infusion, Q4W

Interventions

LP-005 Injection

IV infusion, Q4W

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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

Sponsors

Longbio Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guangsheng He

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Countries

China

Central Contacts

Tingyuan Yang

Role: CONTACT

yangty@longbiopharma.com

86-18611978535

Facility Contacts

Guangsheng He

Role: primary

heguangsheng1972@sina.com

+86 153 1205 2798

Other Identifiers

P10-LP005-05

Identifier Type: -

Identifier Source: org_study_id