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

NCT ID: NCT06687174

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2028-01-31

Brief Summary

Efficacy and safety of MY008211A in IgAN patients

Detailed 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.

Conditions

IgA Nephropathy (IgAN)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MY008211A 200 mg BID

200 mg taken twice a day.

Group Type: EXPERIMENTAL

MY008211A tablets

Intervention Type: DRUG

MY008211A BID

MY008211A 400 mg BID

400 mg taken twice a day.

Group Type: EXPERIMENTAL

MY008211A tablets

Intervention Type: DRUG

MY008211A BID

Placebo

Matching placebo to MY008211A taken twice a day.

Group Type: PLACEBO_COMPARATOR

MY008211A tablets matched placebo

Intervention Type: DRUG

Matching placebo to MY008211A taken twice a day.

Interventions

MY008211A tablets

MY008211A BID

Intervention Type: DRUG

MY008211A tablets matched placebo

Matching placebo to MY008211A taken twice a day.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Createrna Science and Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong Zhang, PH.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Donghui Li, PH.D.

Role: CONTACT

lidonghui@createrna.com

(+86)027-68788900

Facility Contacts

Hong Zhang, PH.D.

Role: primary

hongzh@bjmu.edu.cn

(+86)-010-83572388

Other Identifiers

MY008211A-IgAN-2-01

Identifier Type: -

Identifier Source: org_study_id