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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
Phase 2 trial testing RC18 160mg in Systemic Myasthenia Gravis in 29 participants. Completed in 11 February 2022.
14 January 2022
Quick facts
| Lead sponsor | RemeGen Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 7 July 2020 |
| Primary completion | 14 January 2022 |
| Estimated completion | 11 February 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- RC18 160mg — full drug profile →
- RC18 240 mg — full drug profile →
Conditions studied
- Systemic Myasthenia Gravis — all drugs for Systemic Myasthenia Gravis →
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):
-
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 -
Advances and challenges in the treatment of myasthenia gravis.
Schneider-Gold C, Gilhus NE. · · 2021 · cited 40× · PMID 34987614 · DOI 10.1177/17562864211065406 -
Novel Immunotherapies for Myasthenia Gravis.
Nair SS, Jacob S. · · 2023 · cited 38× · PMID 37038596 · DOI 10.2147/itt.s377056 -
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 -
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 -
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 -
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 -
Treating myasthenia gravis beyond the eye clinic.
Jacob S. · · 2024 · cited 9× · PMID 38789789 · DOI 10.1038/s41433-024-03133-x
Verify or expand the search:
- PubMed search for NCT04302103
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of RC18 160mg
Trials testing the same drug.
- NCT04625153 — RC18 in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial · Phase 2 · terminated
- NCT04291781 — A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy · Phase 2 · completed
Other RemeGen Co., Ltd. trials
Trials by the same sponsor.
- NCT07537881 — A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors · Phase 1, PHASE2 · not yet recruiting
- NCT07462143 — A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer · Phase 2, PHASE3 · not yet recruiting
- NCT07495033 — Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related I · Phase 3 · not yet recruiting
- NCT07416474 — RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Smal · Phase 3 · not yet recruiting
- NCT07249632 — A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG) · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04302103 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RemeGen Co., Ltd.
- Last refreshed: 11 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04302103.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing