Study of SGB-9768 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Sanegene Bio Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
SGB-9768
DrugSGB-9768 will be administered by subcutaneous injection.
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean LDH change from baseline
Time frame
weeks 18-24Sponsors and contacts
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Source ClinicalTrials.gov
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