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New hope for PNH: experimental drug LP-005 enters Mid-Stage trial

NCT ID NCT07212426

Disease control Sponsor: Longbio Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called LP-005 in 30 adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder that destroys red blood cells. The goal is to see if LP-005 can lower a key disease marker (LDH) and raise hemoglobin levels without needing blood transfusions. Participants receive LP-005 injections and are monitored for safety and effectiveness over the study period.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, aged 18 to 65 years. * Diagnosis of PNH based on flow cytometry with clone size \> 10% by granulocytes. * Presence of one or more PNH-related signs or symptoms within 3 months prior to screening or a history of transfusion due to PNH. * LDH level ≥2.0×upper limit of the normal range(ULN). * Hemoglobin level \<100 g/L at screening. Exclusion Criteria: * Active or suspected active viral, bacterial, fungal, or parasitic infection within 14 days prior to screening. * History of meningococcal infection. * History of splenectomy or congenital asplenia. * History of systemic autoimmune disease or known/suspected immunodeficiency. * History of hematopoietic stem cell transplantation. * Use of any complement inhibitor within 3 months prior to screening or within 5 drug half-lives (whichever is longer). * Pregnant or breastfeeding women, or women planning to become pregnant during the study or follow-up period.

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Conditions

The condition(s) this trial relates to.

Hemoglobinuria, Paroxysmal paroxysmal nocturnal hemoglobinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PNH - paroxysmal nocturnal hemoglobinuria

Contacts and locations

Locations

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.