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Not yet recruitingNCT07266155Updated Dec 5, 2025

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

A Phase 2 interventional study of LP-005 Injection in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Longbio Pharma. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Longbio Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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).

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Conditions studied

  • Paroxysmal Nocturnal Hemoglobinuria
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In context

Hemoglobinuria, Paroxysmal

188 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 48 are open to participants now.

This study's planned enrollment of 30 is below the median of 34 across 147 interventional studies indexed under Hemoglobinuria, Paroxysmal.

Browse Hemoglobinuria, Paroxysmal studies →

Lead sponsor

Longbio Pharma is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    LP-005 1200 mg

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

    Biological: LP-005 Injection

  • Experimental
    LP-005 1500 mg

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

    Biological: LP-005 Injection

Interventions

  • BiologicalLP-005 Injection

    IV infusion, Q4W

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What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Change from baseline in serum lactate dehydrogenase (LDH) levels.

    Time frame: Up to approximately 2 years

  2. Change from baseline in hemoglobin levels.

    Time frame: Up to approximately 2 years

  3. Proportion of patients who are transfusion-free.

    Time frame: Up to approximately 2 years

  4. Proportion of patients achieving hemoglobin levels ≥120 g/L

    Time frame: Up to approximately 2 years

  5. Proportion of patients with breakthrough hemolysis

    Time frame: Up to approximately 2 years

  6. Serum concentrations of LP-005.

    Time frame: Up to approximately 2 years

  7. Number of patients with anti-drug antibodies (ADA)

    Time frame: Up to approximately 2 years

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Study locations

1 site
  • The First Affiliated Hospital of Nanjing Medical University
    Nanjing, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07266155
Lead sponsor
Longbio Pharma
Responsible party
Sponsor
First posted
Dec 5, 2025
Start date
Dec 5, 2025 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Dec 5, 2025

Study contacts

Tingyuan Yang
Contact
yangty@longbiopharma.com
86-18611978535
Guangsheng He
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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