A Phase 2 Study of SGB-9768 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE2

Enrollment: 24

Sponsor: Suzhou Sanegene Bio Inc.

Location: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS) Tianjin Tianjin Municipality

Summary

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

Inclusion Criteria: 1. Male and female participants ≥ 18 years of age; 2. Diagnosis of PNH confirmed by flow cytometry, with a PNH clone size \>10% in granulocytes and/or monocytes; 3. Mean hemoglobin level \ 1.5 x Upper Limit of Normal (ULN) at screening. 5. Complement inhibitor-naïve, or previous complement inhibitor therapy discontinued for more than 5 drug half-lives or 3 months before randomization. 6. 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: 1. Patients with reticulocytes \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07796256). StuddyBuddy aggregates publicly available trial information.