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NCT05687526
A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
Completed
Phase 1
Last updated 9 March 2026
What this trial tests
Phase 1 trial testing Telitacicept in Systemic Lupus Erythematosus in 16 participants. Completed in 14 November 2025.
Timeline
25 May 2023
Primary endpoint
14 November 2025
14 November 2025
14 November 2025
Quick facts
| Lead sponsor | RemeGen Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 25 May 2023 |
| Primary completion | 14 November 2025 |
| Estimated completion | 14 November 2025 |
| Sites | 12 locations across China |
Drugs / interventions tested
- Telitacicept — 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 5 to 17, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, open-label, phase 1 study.
Publications & conference data
3 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 -
Juvenile-onset Systemic Lupus Erythematosus: Recent Advances in Pathogenesis and Treatment.
Natoli V, Charras A, Smith EM, Hedrich CM. · · 2025 · cited 1× · PMID 41410901 · DOI 10.1007/s11926-025-01207-7 -
Pathogenesis, Treatment Advances, and Renal Outcomes in Childhood-Onset Lupus Nephritis.
Safdar A. · · 2026 · PMID 41709467 · DOI 10.1177/00099228261422294
Verify or expand the search:
- PubMed search for NCT05687526
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Telitacicept
Trials testing the same drug.
- NCT07522099 — Chinese Adults With Kidney Disease · Phase 2 · 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
- NCT07249632 — A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG) · Phase 3 · recruiting
- NCT07052981 — Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculiti · Phase 3 · not yet recruiting
- NCT06375005 — Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis · Phase 2 · recruiting
Other recruiting trials for Systemic Lupus Erythematosus
Currently open trials in the same condition.
- NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
- NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
- NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting
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)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05687526 (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: 9 March 2026
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/NCT05687526.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing