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NCT04302103

A Study of TACI(Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor)-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis

Completed Phase 2 Last updated 11 October 2023
What this trial tests

Phase 2 trial testing RC18 160mg in Systemic Myasthenia Gravis in 29 participants. Completed in 11 February 2022.

Timeline
7 July 2020
Primary endpoint
14 January 2022
11 February 2022

Quick facts

Lead sponsorRemeGen Co., Ltd.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment29
Start date7 July 2020
Primary completion14 January 2022
Estimated completion11 February 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Systemic Myasthenia Gravis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.

Publications & conference data

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

  1. B cell depletion therapies in autoimmune disease: advances and mechanistic insights.
    Lee DSW, Rojas OL, Gommerman JL. · · 2021 · cited 496× · PMID 33324003 · DOI 10.1038/s41573-020-00092-2
  2. Advances and challenges in the treatment of myasthenia gravis.
    Schneider-Gold C, Gilhus NE. · · 2021 · cited 40× · PMID 34987614 · DOI 10.1177/17562864211065406
  3. Novel Immunotherapies for Myasthenia Gravis.
    Nair SS, Jacob S. · · 2023 · cited 38× · PMID 37038596 · DOI 10.2147/itt.s377056
  4. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis.
    Yin J, Zhao M, Xu X, Zhang M, et al · · 2024 · cited 33× · PMID 38726639 · DOI 10.1111/ene.16322
  5. Immunotherapies in MuSK-positive Myasthenia Gravis; an IgG4 antibody-mediated disease.
    Vakrakou AG, Karachaliou E, Chroni E, Zouvelou V, et al · · 2023 · cited 33× · PMID 37564637 · DOI 10.3389/fimmu.2023.1212757
  6. 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
  7. New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making.
    Gerischer L, Doksani P, Hoffmann S, Meisel A. · · 2025 · cited 18× · PMID 39869260 · DOI 10.1007/s40259-024-00701-1
  8. Treating myasthenia gravis beyond the eye clinic.
    Jacob S. · · 2024 · cited 9× · PMID 38789789 · DOI 10.1038/s41433-024-03133-x

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