NCT04905212

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

Terminated Phase 2 Last updated 6 December 2023

What this trial tests

Phase 2 trial testing Telitacicept 160mg in IgA Nephropathy in 15 participants. Terminated before completion.

Timeline

4 November 2021

Primary endpoint
9 November 2023

9 November 2023

Quick facts

Lead sponsor	RemeGen Co., Ltd.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	15
Start date	4 November 2021
Primary completion	9 November 2023
Estimated completion	9 November 2023
Sites	8 locations across United States

Drugs / interventions tested

• Telitacicept 160mg — full drug profile →
• Telitacicept 240mg — full drug profile →
• Placebo

Conditions studied

• IgA Nephropathy — all drugs for IgA Nephropathy →

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with IgA Nephropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment of IgA Nephropathy: A Rapidly Evolving Field.
   El Karoui K, Fervenza FC, Fervenza FC, De Vriese AS. · · 2024 · cited 69× · PMID 37772889 · DOI 10.1681/asn.0000000000000242
2. TNF superfamily control of tissue remodeling and fibrosis.
   Steele H, Cheng J, Willicut A, Dell G, et al · · 2023 · cited 50× · PMID 37465675 · DOI 10.3389/fimmu.2023.1219907
3. Cutaneous Lupus Erythematosus: An Update on Pathogenesis and Future Therapeutic Directions.
   Niebel D, de Vos L, Fetter T, Brägelmann C, et al · · 2023 · cited 47× · PMID 37140884 · DOI 10.1007/s40257-023-00774-8
4. IgA nephropathy in adults-treatment standard.
   Gleeson PJ, O'Shaughnessy MM, Barratt J. · · 2023 · cited 38× · PMID 37418237 · DOI 10.1093/ndt/gfad146
5. Novel Treatment Paradigms: Primary IgA Nephropathy.
   Selvaskandan H, Barratt J, Cheung CK. · · 2024 · cited 31× · PMID 38344739 · DOI 10.1016/j.ekir.2023.11.026
6. IgA Nephropathy: Current Understanding and Perspectives on Pathogenesis and Targeted Treatment.
   Du Y, Cheng T, Liu C, Zhu T, et al · · 2023 · cited 31× · PMID 36673113 · DOI 10.3390/diagnostics13020303
7. Telitacicept following plasma exchange in the treatment of subjects with recurrent neuromyelitis optica spectrum disorders: A single-center, single-arm, open-label study.
   Ding J, Jiang X, Cai Y, Pan S, et al · · 2022 · cited 31× · PMID 35851754 · DOI 10.1111/cns.13904
8. New Treatment Strategies for IgA Nephropathy: Targeting Plasma Cells as the Main Source of Pathogenic Antibodies.
   Maixnerova D, El Mehdi D, Rizk DV, Zhang H, et al · · 2022 · cited 29× · PMID 35628935 · DOI 10.3390/jcm11102810