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New complement inhibitor takes on established PNH drug in phase III trial

NCT ID NCT07816237

Disease control Sponsor: Bisirna Therapeutics (Suzhou) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing an experimental drug called VSA012 against eculizumab in adults with paroxysmal nocturnal hemoglobinuria (PNH) who have not received complement inhibitor therapy. The trial enrolls about 70 participants and compares how well each treatment controls hemolysis and raises hemoglobin levels over 24 weeks. The goal is to see whether VSA012 is safe and effective enough to become another option for PNH.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VSA012 injection, an experimental complement inhibitor, compared with eculizumab
What this could lead to
If VSA012 works as well as or better than eculizumab, it could offer another treatment option for people with PNH who have not yet tried complement inhibitors.
What could go wrong
The trial is relatively small and open-label, so results may not apply to everyone. VSA012 could fail to control hemolysis or cause unexpected side effects, and complement inhibitors carry a risk of serious meningococcal infections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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 75 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 and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size≥10%. * Mean hemoglobin level \<100 g/L at screening. * LDH \> 1.5 x Upper Limit of Normal (ULN) at screening. * Vaccination against Neisseria meningitidis infection is required prior to the * start of study treatment. If not received previously, vaccination against * Streptococcus pneumoniae and Haemophilus influenzae infections should be given. Exclusion Criteria: * Known or suspected hereditary or acquired complement deficiency; * Presence or suspicion of a systemic active bacterial, viral, or fungal infection * History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.) * Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L. * Positive of HIV, HBsAg or HCVAb. * History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus. * Previous splenectomy. * A history of malignancy within 5 years before screening

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Conditions

The condition(s) this trial relates to.

Hemoglobinuria, Paroxysmal paroxysmal nocturnal hemoglobinuria meningococcal infection prevention target

As listed by the trial registrant

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

Paroxysmal nocturnal hemoglobinuria, PNH

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Changsha

    Changsha, Hunan, China

  • Chengdu

    Chengdu, Sichuan, China

  • Guangzhou

    Guangzhou, Guangdong, China

  • Ha'erbin

    Harbin, Heilongjiang, China

  • Institute of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, China

  • Jilin

    Jilin City, Changchun, China

  • Nanning

    Nanning, Guangxi, China

  • Nantong

    Nantong, Jiangsu, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

  • Quanzhou

    Quanzhou, Fujian, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • Wuhan

    Wuhan, Hubei, China

  • Xi'an

    Xi’an, Shanxi, China

  • Zhengzhou

    Zhengzhou, Henan, China

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