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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Efficacy and safety of MY008211A in IgAN patients

Study Overview

• Status: Not yet recruiting
• Conditions: IgA Nephropathy (IgAN)
• Intervention / Treatment: Drug: MY008211A tablets; Drug: MY008211A tablets matched placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Donghui Li, PH.D.; Phone Number: (+86)027-68788900; Email: lidonghui@createrna.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
      • Contact: Hong Zhang, PH.D.; Phone Number: (+86)-010-83572388; Email: hongzh@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MY008211A 200 mg BID; 200 mg taken twice a day.	Drug: MY008211A tablets; MY008211A BID
Experimental: MY008211A 400 mg BID; 400 mg taken twice a day.	Drug: MY008211A tablets; MY008211A BID
Placebo Comparator: Placebo; Matching placebo to MY008211A taken twice a day.	Drug: MY008211A tablets matched placebo; Matching placebo to MY008211A taken twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12.	Participants collected their urine over a 24-hour period.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12.	Participants collected their urine over a 24-hour period.	up to 24 weeks
The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period.	Participants collected all of their urine over a 24-hour period.	up to 24 weeks
The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period.	Participants collected all of their urine over a 24-hour period.	up to 24 weeks
The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period.	Participants collected all of their urine over a 24-hour period.	up to 24 weeks
Change from baseline in serum creatinine at each visit during treatment period.	Serum creatinine	up to 24 weeks
Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period.	eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).	up to 24 weeks

Collaborators and Investigators

• Sponsor: Wuhan Createrna Science and Technology Co., Ltd
• Investigators: Principal Investigator: Hong Zhang, PH.D., Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: kidney disease; Primary glomerular disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: MY008211A-IgAN-2-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No