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A Study of the Efficacy and Safety of FXS6837 Capsules Compared to Eculizumab for 24 Weeks in Patients With PNH.

NCT07747090 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-05

No results posted yet for this study

Summary

An open label study to evaluate the efficacy and safety of FXS6837 capsules compared to eculizumab in naive PNH patients. About 90 PNH patients who are naive to complement inhibitor therapies will be enrolled to take FXS6837 capsules or eculizumab for 24 weeks according to protocol.

Conditions

Interventions

BIOLOGICAL

Eculizumab infusion

Eculizumab infusion treated for 24 weeks

DRUG

FXS6837 Capsule

FXS6837 capsule orally taken for 24 weeks

Sponsors & Collaborators

  • Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Rong Fu · Tianjin Medical University General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-10
Primary Completion
2028-05-05
Completion
2028-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07747090 on ClinicalTrials.gov