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

• Sponsor: RemeGen Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04905212
• Collaborator: (none)
• Enrollment: 30
• Locations: 16
• Arms: 3
• Anticipated Duration (Months): 9.9
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
IgA Nephropathy	Drug: Telitacicept 160mg; Drug: Telitacicept 240mg; Drug: Placebo	Phase 2

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 3 parts: a screening period, a double-blind treatment period, and a follow-up period. Subjects with confirmed IgA nephropathy within 8 years will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
• Actual Study Start Date: Nov 4, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change from baseline in 24-hour urine protein at Week 24. [Week 24]

   Change from baseline in urine protein over 24 hours to Week 24 will be measured

Secondary Outcome Measures

1. Change from baseline in Estimated Glomerular Filtration Rate (eGFR) [Week 0, 4, 8, 12, 16, 20, and 24]

   Change from baseline in eGFR by visit

2. Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) [Week 0, 4, 8, 12, 16, 20 and 24]

   Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.

3. Changes from baseline in immunological parameters [Week 0, 4, 8, 12, 16, 20, 24 and 27]

   Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)

Other Outcome Measures

1. The incidence and severity of adverse events [27 weeks]

   Number and intensity of adverse events

2. Immunogenicity endpoints [Week 0, 4, 8, 12, 16, 20, 24 and 27]

   Anti-drug antibody (ADA), incidence, titers and duration

3. Biomaker endpoints serum concentration [Week 0, 4, 8, 12, 16, 20, and 24]

   BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex

4. Pharmacokinetic endpoints [Week 0, 4, 8, 12, 16, 20, 24 and 27]

   Free Telitacicept serum concentration and total Telitacicept serum concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. IgA nephropathy confirmed by pathological biopsy within 8 years prior to randomization;

2. Male or female aged ≥ 18 years old and ≤ 70 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Remegen Site #5	Los Angeles	California	United States	90022
2	Remegen Site #4	Los Angeles	California	United States	90033
3	Remegen Site #13	Los Angeles	California	United States	91324
4	Remegen Site #14	Los Angeles	California	United States	91324
5	Remegen Site #6	Los Angeles	California	United States	92868
6	Remegen Site #10	Sacramento	California	United States	95687
7	Remegen Site #8	San Francisco	California	United States	94080
8	Remegen Site #16	Fort Lauderdale	Florida	United States	33071
9	Remegen Site #12	Orlando	Florida	United States	32792
10	Remegen Site #15	West Palm Beach	Florida	United States	33462
11	Remegen Site #17	Augusta	Georgia	United States	30909
12	Remegen Site #2	Philadelphia	Pennsylvania	United States	17033
13	Remegen Site #7	Dallas	Texas	United States	75231
14	Remegen Site #3	El Paso	Texas	United States	79925
15	Remegen Site #11	Salt Lake City	Utah	United States	84088
16	Remegen Site #1	Alexandria	Virginia	United States	22304

Sponsors and Collaborators

• RemeGen Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RemeGen Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04905212
• Other Study ID Numbers: RC18G004
• First Posted: May 27, 2021
• Last Update Posted: Feb 24, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by RemeGen Co., Ltd.: Berger Disease; Berger's Disease; IGA Glomerulonephritis; IGA Nephropathy; Primary IGA Nephropathy; Immunoglobulin A Nephropathy Nephritis; IGA Type Nephropathy, IGA
• Additional relevant MeSH terms: Kidney Diseases; Glomerulonephritis, IGA

Study Results

No Results Posted as of Feb 24, 2022