ClinicalTrials.gov record NCT07796256

Study of SGB-9768 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 5, 2026

A Multicenter, Randomized, Open-Label Phase II Study to Evaluate the Efficacy and Safety of Multiple Doses of SGB-9768 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a randomized, open-label Phase II study that evaluates multiple doses of SGB-9768 in adults with paroxysmal nocturnal hemoglobinuria (PNH). Participants are assigned to one of three dosing arms and receive SGB-9768 by subcutaneous injection. The study will assess safety and measures treatment effect using lactate dehydrogenase (LDH) change, with the primary LDH measurement taken during weeks 18–24.

What it is studying. The study is testing the safety and efficacy of different multiple-dose regimens of SGB-9768 given by subcutaneous injection in adults with PNH, with mean LDH change from baseline (measured at weeks 18–24) as a primary measurement.

What the researchers hope to learn. Scientifically, the study aims to evaluate the efficacy and safety profile of multiple dosing regimens of SGB-9768 in adults with PNH and to measure mean change in LDH as an indicator of treatment effect.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is a multicenter, randomized, open-Label Phase II study to evaluate the efficacy and safety of multiple doses of SGB-9768 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • SGB-9768

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Male and female participants ≥ 18 years of age;
  • Diagnosis of PNH confirmed by flow cytometry, with a PNH clone size >10% in granulocytes and/or monocytes;
  • Mean hemoglobin level <100 g/L at screening.
  • Lactate Dehydrogenase (LDH) > 1.5 x Upper Limit of Normal (ULN) at screening.
  • Complement inhibitor-naïve, or previous complement inhibitor therapy discontinued for more than 5 drug half-lives or 3 months before randomization.
  • 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

  • Patients with reticulocytes <100x10⁹/L; platelets <30x10⁹/L; neutrophils <0.5x10⁹/L.
  • History of congenital asplenia or splenectomy.
  • Known or suspected hereditary or acquired complement deficiencies/abnormalities.
  • Active or recurrent invasive infections caused by encapsulated bacteria (e.g., Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae).
  • Active systemic bacterial, viral, or fungal infection within 14 days before randomization.
  • Evidence or history of tuberculosis infection (except adequately treated inactive tuberculosis with negative screening results).
  • Recurrent chronic infections within 1 year before screening.
  • Positive virology tests indicating active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), or syphilis infection.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized into one of three groups and receive multiple doses of SGB-9768 given by subcutaneous injection. Vaccination against Neisseria meningitidis is required before starting study treatment; if not previously received, vaccinations against Streptococcus pneumoniae and Haemophilus influenzae should also be given. Blood samples, including tests for lactate dehydrogenase (LDH), will be taken at baseline and during treatment, with LDH change measured at weeks 18–24 as the primary outcome. Participants will attend study visits for dosing and follow-up assessments while on the study.

How the study is structured. Phase II interventional treatment study. Adults are randomized into one of three parallel dose groups; the study is open-label (no masking). All groups receive multiple subcutaneous doses of SGB-9768. The main effectiveness measure is the change in LDH from baseline measured around weeks 18–24.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on paroxysmal nocturnal hemoglobinuria

Clinical trials44 trials listed for paroxysmal nocturnal hemoglobinuriaEvery trial the registry lists for paroxysmal nocturnal hemoglobinuria, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in paroxysmal nocturnal hemoglobinuria researchLatest monthly update: September 2026. Includes: Treatment access. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 31, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Study completion
Dec 31, 2027 (estimated)
Target enrollment
24 participants (estimated)
Last updated on registry
Sep 4, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Suzhou Sanegene Bio Inc.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
open-Label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Upper Limit of Normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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