Study of SGB-9768 in Patients With Paroxysmal Nocturnal Hemoglobinuria

NCT07796256 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: SGB-9768-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

PNH - Paroxysmal Nocturnal Hemoglobinuria

Outcome Measures

Primary Outcomes (1)

• Mean LDH change from baseline

  weeks 18-24

Study Arms (3)

Arm 1

EXPERIMENTAL

Participants will receive multiple doses of SGB-9768.

Drug: SGB-9768

Arm 2

EXPERIMENTAL

Participants will receive multiple doses of SGB-9768.

Drug: SGB-9768

Arm 3

EXPERIMENTAL

Participants will receive multiple doses of SGB-9768.

Drug: SGB-9768

Interventions

SGB-9768 DRUG

SGB-9768 will be administered by subcutaneous injection.

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Sanegene Bio Inc.: lead

Study Sites (2)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

Tianjin, Tianjin Municipality, 300020, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)