Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Wuhan Createrna Science and Technology

Status and phase: Not yet enrolling; Phase 2

Conditions: IgA Nephropathy (IgAN)

Treatments: Drug: MY008211A tablets matched placebo; Drug: MY008211A tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06687174

MY008211A-IgAN-2-01

Details and patient eligibility

About

Efficacy and safety of MY008211A in IgAN patients

Full description

This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females ≥ 18 and ≤ 75 years of age at Screening.
2. Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
3. Subjects with a biopsy-confirmed diagnosis of IgAN.
4. Urine protein ≥0.75 g/24h from a 24h urine collection.
5. All patients must have been on stable supportive care including a maximally tolerated dose or approved maximal dose of ACEi or ARB therapy for at least 90 days prior to the first administration of study drug.
6. Subjects who received SGLT2i must have been on a stable treatment with the maximum allowed or tolerated dose prior to the first administration of study drug.
7. Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years.
8. Vaccination for the prevention of S. pneumoniae is required within 5 years.

Exclusion criteria

1. Systolic blood pressure >130 mm Hg or diastolic blood pressure >80 mm Hg.
2. Presence of any secondary IgAN.
3. Presence of rapidly progressive glomerulonephritis.
4. Presence of other chronic kidney diseases.
5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
6. A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci.
7. Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing.
8. Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing.
9. Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication.
10. Patients who previously have received biologic agent or monoclonal antibodies prior to start of study drug dosing within 5 half-lives or 30 days (whichever is longer).
11. Patients who have received live/attenuated vaccines within the 4 weeks prior to randomization, or plan to receive during the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 3 patient groups, including a placebo group

MY008211A 200 mg BID

Experimental group

Description:

200 mg taken twice a day.

Treatment:

Drug: MY008211A tablets

MY008211A 400 mg BID

Experimental group

Description:

400 mg taken twice a day.

Treatment:

Drug: MY008211A tablets

Placebo

Placebo Comparator group

Description:

Matching placebo to MY008211A taken twice a day.

Treatment:

Drug: MY008211A tablets matched placebo