A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

Study Overview

• Status: Terminated
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: Telitacicept 160mg; Drug: Telitacicept 240mg; Drug: Placebo

Detailed Description

IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

The study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Remegen Biosciences; Phone Number: 1-301-284-1015; Email: RC18_IGANstudy@remegenbio.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90022
      • Remegen Site #5
    • Los Angeles, California, United States, 91324
      • Remegen Site #13
    • Los Angeles, California, United States, 91324
      • Remegen Site #14
    • Sacramento, California, United States, 95687
      • Remegen Site #10
    • San Francisco, California, United States, 94080
      • Remegen Site #8
  • Florida
    • Fort Lauderdale, Florida, United States, 33071
      • Remegen Site #16
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Remegen Site #17
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 17033
      • Remegen Site #2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. IgA nephropathy confirmed by pathological biopsy;
2. Male or female aged ≥ 18 years old;
3. Average 24-hour urine total protein ≥ 0.75 g/24 h
4. Estimated GFR (using the CKD-EPI formula) > 30 mL/min per 1.73 m^2;
5. Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy.

Exclusion Criteria:

1. Patients with clinically significant abnormal laboratory tests at screening;
2. Evidence of rapid eGFR decrease > 15 ml/min during screening;
3. Renal or other organ transplantation prior to, or expected during, the study;
4. Patients with secondary IgA nephropathy;
5. Patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with IgA deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation;
6. Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening;
7. Immunocompromised individuals.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept 160mg; Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses	Drug: Telitacicept 160mg; Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
Experimental: Telitacicept 240mg; Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses	Drug: Telitacicept 240mg; Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
Placebo Comparator: Placebo; Placebo subcutaneous injection once weekly, and a total of 24 doses	Drug: Placebo; Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 24-hour urine protein at Week 24.	Change from baseline in urine protein over 24 hours to Week 24 will be measured	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48	Change from baseline in eGFR by visit	Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;	Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.	Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48
Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.	Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)	Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and severity of adverse events	Number and intensity of adverse events	27 weeks
Immunogenicity endpoints	Anti-drug antibody (ADA), incidence, titers and duration	Week 0, 4, 8, 12, 16, 20, 24 and 27
Biomaker endpoints serum concentration	BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex	Week 0, 4, 8, 12, 16, 20, and 24
Pharmacokinetic endpoints	Free Telitacicept serum concentration and total Telitacicept serum concentration	Week 0, 4, 8, 12, 16, 20, 24 and 27

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Berger Disease; Berger's Disease; IGA Glomerulonephritis; IGA Nephropathy; Primary IGA Nephropathy; Immunoglobulin A Nephropathy Nephritis; IGA Type Nephropathy, IGA
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: RC18G004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No