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NCT04082416
Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
Phase 3 trial testing Placebo plus standard therapy in Systemic Lupus Erythematosus in 335 participants. Completed in 30 June 2022.
24 April 2022
Quick facts
| Lead sponsor | RemeGen Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 335 |
| Start date | 16 October 2019 |
| Primary completion | 24 April 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Placebo plus standard therapy — full drug profile →
- RC18 160 mg plus standard therapy — full drug profile →
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
Sponsor
RemeGen Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Systemic lupus erythematosus: pathogenesis and targeted therapy.
Su X, Yu H, Lei Q, Chen X, et al · · 2024 · cited 33× · PMID 39472388 · DOI 10.1186/s43556-024-00217-8 -
Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.
Veerasubramanian PK, Wynn TA, Quan J, Karlsson FJ. · · 2024 · cited 26× · PMID 39297883 · DOI 10.1084/jem.20240806 -
Role of telitacicept in the treatment of IgA nephropathy.
Wu L, Du X, Lu X. · · 2023 · cited 22× · PMID 37737205 · DOI 10.1186/s40001-023-01320-2 -
Lupus Nephritis: Current Perspectives and Moving Forward.
Lichtnekert J, Anders HJ, Lech M. · · 2022 · cited 16× · PMID 36483271 · DOI 10.2147/jir.s363722 -
A Comprehensive Review of Biological Agents for Lupus: Beyond Single Target.
Yang B, Zhao M, Wu H, Lu Q. · · 2020 · cited 12× · PMID 33123125 · DOI 10.3389/fimmu.2020.539797 -
Targeted Therapy for SLE-What Works, What Doesn't, What's Next.
Venturelli V, Isenberg DA. · · 2023 · cited 8× · PMID 37176637 · DOI 10.3390/jcm12093198 -
A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus.
van Vollenhoven RF, Wang L, Merrill JT, Liu Y, et al · · 2025 · cited 6× · PMID 41092329 · DOI 10.1056/nejmoa2414719 -
The role of B cell-activating factor system in autoimmune diseases: mechanisms, disease implications, and therapeutic advances.
Li L, Shen S, Shao S, Dang E, et al · · 2025 · cited 4× · PMID 40547016 · DOI 10.3389/fimmu.2025.1538555
Verify or expand the search:
- PubMed search for NCT04082416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04082416 (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 May 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/NCT04082416.
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