Efficacy, Safety, and Pharmacokinetics of LP-005 Injectio... | NCT07266155

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

NCT07266155

Sponsor

Longbio Pharma

Status

Not yet recruiting

Last Update Posted

Dec 5, 2025Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Interventions

LP-005 Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2025Estimated

Primary Completion Date

Dec 30, 2027Estimated

Completion Date

May 1, 2028Estimated

First Submitted Date

Nov 24, 2025

First Submission Date that Met QC Criteria

Nov 24, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LP-005 1200 mg	Experimental	Patients will receive intravenous infusion of LP-005 Injection at a dose of 1200 mg once every 4 weeks.	Biological: LP-005 Injection
LP-005 1500 mg	Experimental	Patients will receive intravenous infusion of LP-005 Injection at a dose of 1500 mg once every 4 weeks.	Biological: LP-005 Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LP-005 Injection	Biological	IV infusion, Q4W	LP-005 1200 mg LP-005 1500 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (AEs)		Up to approximately 2 years

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in serum lactate dehydrogenase (LDH) levels.		Up to approximately 2 years
Change from baseline in hemoglobin levels.		Up to approximately 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients have fully understood the trial, have voluntarily agreed to participate in this clinical trial, and have signed a written Informed Consent Form (ICF).
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.
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.
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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases