Paroxysmal Nocturnal HemoglobinuriaPhase 2NCT07266155
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Phase 2 study testing LP-005 Injection in people with Paroxysmal Nocturnal Hemoglobinuria, run by Longbio Pharma at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paroxysmal Nocturnal Hemoglobinuria
- What is being tested?
- LP-005 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2025to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Guangsheng He, +86 153 1205 2798, heguangsheng1972@sina.com
About this study
Official title: A Phase Ⅱ Extension Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
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
- Being tested
- LP-005 Injection
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-005 InjectionBiological
IV infusion, Q4W
| Study group | Role | What they receive |
|---|---|---|
| LP-005 1200 mg | Experimental | Patients will receive intravenous infusion of LP-005 Injection at a dose of 1200 mg once every 4 weeks. Receives: 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. Receives: Biological: LP-005 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to approximately 2 years
Secondary outcomes (7)
Change from baseline in serum lactate dehydrogenase (LDH) levels.
Measured: Up to approximately 2 years
Change from baseline in hemoglobin levels.
Measured: Up to approximately 2 years
Proportion of patients who are transfusion-free.
Measured: Up to approximately 2 years
Proportion of patients achieving hemoglobin levels ≥120 g/L
Measured: Up to approximately 2 years
Proportion of patients with breakthrough hemolysis
Measured: Up to approximately 2 years
Serum concentrations of LP-005.
Measured: Up to approximately 2 years
Number of patients with anti-drug antibodies (ADA)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start5 Dec 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Nocturnal HemoglobinuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guangsheng He, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266155
- Sponsor's protocol ID
- P10-LP005-05
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Extension Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
- ClinicalTrials.gov ID
- NCT07266155
- Acronym / sponsor ID
- P10-LP005-05
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Longbio PharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP-005 1200 mg | Experimental | Biological: LP-005 InjectionPatients will receive intravenous infusion of LP-005 Injection at a dose of 1200 mg once every 4 weeks. |
| LP-005 1500 mg | Experimental | Biological: LP-005 InjectionPatients will receive intravenous infusion of LP-005 Injection at a dose of 1500 mg once every 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-005 InjectionIV infusion, Q4W | Biological | LP-005 1200 mg, LP-005 1500 mg |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to approximately 2 years
7 secondary outcomes
Change from baseline in serum lactate dehydrogenase (LDH) levels.
Time frame: Up to approximately 2 years
Change from baseline in hemoglobin levels.
Time frame: Up to approximately 2 years
Proportion of patients who are transfusion-free.
Time frame: Up to approximately 2 years
Proportion of patients achieving hemoglobin levels ≥120 g/L
Time frame: Up to approximately 2 years
Proportion of patients with breakthrough hemolysis
Time frame: Up to approximately 2 years
Serum concentrations of LP-005.
Time frame: Up to approximately 2 years
Number of patients with anti-drug antibodies (ADA)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guangsheng He principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LP-005 Injection in people with Paroxysmal Nocturnal Hemoglobinuria, run by Longbio Pharma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingyuan Yang (86-18611978535, yangty@longbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.