Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2025-12-30

Brief Summary

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The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.

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Detailed Description

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This is a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this study is to determine whether MY008211A compared to eculizumab is efficacious and safe for the treatment of PNH patients who were naive to complement inhibitor therapy.

Conditions

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Paroxysmal Nocturnal Haemoglobinuria (PNH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MY008211A tablets

MY008211A tablets 400mg BID

Group Type EXPERIMENTAL

MY008211A tablets

Intervention Type DRUG

Participants will receive MY008211A at a dose of 400 mg orally b.i.d for 24 weeks

Eculizumab

Eculizumab Injection

Group Type ACTIVE_COMPARATOR

Eculizumab Injection

Intervention Type DRUG

Eculizumab Injection for 24 weeks

Interventions

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MY008211A tablets

Participants will receive MY008211A at a dose of 400 mg orally b.i.d for 24 weeks

Intervention Type DRUG

Eculizumab Injection

Eculizumab Injection for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
2. Mean hemoglobin level \<100 g/L at screening.
3. LDH \> 1.5 x Upper Limit of Normal (ULN) at screening.
4. 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 \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
2. History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
3. Known or suspected hereditary complement deficiency.
4. Previous bone marrow or hematopoietic stem cell transplantation.
5. Previous splenectomy.
6. A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No