8 completed, 3 terminated, 2 unknown. 7 Phase 2, 5 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 4, Terminated 2, Unknown 1 |
| Phase 3 | 5 | Completed 3, Terminated 1, Unknown 1 |
| Phase 1 | 1 | Completed 1 |
Follow this drug Literature Review of RC-18 trials Research Report on RC-18
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Telitacicept in Lupus Nephritis Telitacicept 240 mg, Telitacicept 160 mg, Placebo - Lupus Nephritis | Phase 2 | Unknown | RemeGen Co., Ltd. | 120 | 2023-04-17 | 2024-09-23 |
| A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome Telitacicept 80 mg, Telitacicept 160 mg, Placebo - Primary Sjogren's Syndrome | Phase 3 | Completed | RemeGen Co., Ltd. | 381 | 2023-04-06 | 2025-10-01 |
| Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus Telitacicept, Interleukin-2 - Systemic Lupus Erythematosus | Phase 3 | Unknown | Liu Tian | 60 | 2023-02-07 | 2024-04-03 |
| RC18 in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II Trial RC18 160mg, RC18 240mg - Multiple Sclerosis, Relapsing-Remitting | Phase 2 | Terminated | RemeGen Co., Ltd. | 8 | 2021-05-13 | 2026-04-13 |
| 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 RC18 160mg, RC18 240 mg - Systemic Myasthenia Gravis | Phase 2 | Completed | RemeGen Co., Ltd. | 29 | 2020-07-07 | 2026-05-27 |
| A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy RC18 160mg, RC18 240mg, placebo - Primary IgA Nephropathy | Phase 2 | Completed | RemeGen Co., Ltd. | 44 | 2020-04-13 | 2024-09-19 |
| A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome Placebo, RC18 240 mg, RC18 160 mg - Primary Sjögren's Syndrome | Phase 2 | Completed | RemeGen Co., Ltd. | 42 | 2019-11-21 | 2026-05-27 |
| Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) Placebo plus standard therapy, RC18 160 mg plus standard therapy - Systemic Lupus Erythematosus | Phase 3 | Completed | RemeGen Co., Ltd. | 335 | 2019-10-16 | 2023-05-11 |
| A Phase I Study of TACI-antibody Fusion Protein Injection (RC18) in Healthy Adult Chinese Subjects Tai Ai(RC18) 80mg, Tai Ai(RC18) 160mg, RC18 240mg - Healthy | Phase 1 | Completed | RemeGen Co., Ltd. | 36 | 2019-09-17 | 2020-01-22 |
| A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders Placebo, RC18 160 mg - Neuromyelitis Optica Spectrum Disorders | Phase 3 | Terminated | RemeGen Co., Ltd. | 178 | 2018-01-29 | 2026-04-13 |
| A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects with Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. Placebo plus MTX, RC18 160 mg plus MTX - Moderate and Severe RheumatoId Arthritis | Phase 3 | Completed | RemeGen Co., Ltd. | 479 | 2017-03-29 | 2024-09-26 |
| Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) Placebo plus standard therapy, RC18 80 mg plus standard therapy, RC18 160 mg plus standard therapy - Systemic Lupus Erythematosus | Phase 2 | Completed | RemeGen Co., Ltd. | 249 | 2015-12-01 | 2020-03-04 |
| A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-α Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis Placebo plus MTX, RC18 160 mg plus MTX - Moderate and Severe Rheumatoid Arthritis | Phase 2 | Terminated | RemeGen Co., Ltd. | 60 | 2015-10-01 | 2019-04-03 |
Lupus Erythematosus, Systemic (3) · Arthritis, Rheumatoid (2) · Lymphoma, Follicular (2) · Glomerulonephritis, IGA (1) · Lupus Nephritis (1) · Multiple Sclerosis, Relapsing-Remitting (1) · Nephritis (1) · Neuromyelitis Optica (1)
RemeGen Co., Ltd. (12) · Liu Tian (1)
China (13)
Fengchun Zhang (2) · Chunde Bao (1) · Fengchun Zhang, M.D. (1) · Hong Zhang, M.D. (1) · Huan Zhou, M.D. (1) · Xianhao Xu, M.D. (1) · Zhanguo Li (1) · Zhijun Li, M.D. (1)
PMID 37399108, PMID 38129117, PMID 38299639, PMID 38726639, PMID 40465397, PMID 41092329, PMID 41408192