NCT05673993 is a Phase 3 clinical trial of Telitacicept 80 mg in Primary Sjogren's Syndrome, sponsored by RemeGen Co., Ltd..

Who is sponsoring NCT05673993?

NCT05673993 is sponsored by RemeGen Co., Ltd..

What drugs are being tested in NCT05673993?

Interventions in NCT05673993: Telitacicept 80 mg, Telitacicept 160 mg, Placebo.

What condition does NCT05673993 study?

NCT05673993 studies Primary Sjogren's Syndrome.

Is NCT05673993 still recruiting?

NCT05673993 is currently completed. Last updated 1 October 2025.

Last reviewed 2025-10-01 · How we verify

NCT05673993

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome

Completed Phase 3 Last updated 1 October 2025

What this trial tests

Phase 3 trial testing Telitacicept 80 mg in Primary Sjogren's Syndrome in 381 participants. Completed in 6 May 2025.

Timeline

6 April 2023

Primary endpoint
29 October 2024

6 May 2025

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	381
Start date	6 April 2023
Primary completion	29 October 2024
Estimated completion	6 May 2025
Sites	78 locations across China

Drugs / interventions tested

Telitacicept 80 mg — full drug profile →
Telitacicept 160 mg — full drug profile →
Placebo

Conditions studied

Primary Sjogren's Syndrome — all drugs for Primary Sjogren's Syndrome →

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Primary Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of subcutaneous Telitacicept versus placebo in subjects with active primary Sjogren's Syndrome.

Publications & conference data

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

The Latest Progress in the Application of Telitacicept in Autoimmune Diseases.
Liu B, Zhao Y, Liu D, Li X, et al · · 2024 · cited 6× · PMID 39664967 · DOI 10.2147/dddt.s493923
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
Heterogeneity of antibody-secreting cells infiltrating autoimmune tissues.
Giovannini D, Belbezier A, Baillet A, Bouillet L, et al · · 2023 · cited 2× · PMID 36895558 · DOI 10.3389/fimmu.2023.1111366
Regulatory T cell therapy for Sjögren's disease: From pathogenesis to targeted treatment.
Lim ZFS, Hoi AY, Vincent FB, Ooi JD, et al · · 2025 · PMID 40978495 · DOI 10.1016/j.jtauto.2025.100311

Verify or expand the search:

Other recruiting trials for Primary Sjogren's Syndrome

Currently open trials in the same condition.

NCT06967038 — Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk Lymphoma Patients With Primary Sjogren's Syndrome · Phase 1, PHASE2 · 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 NCT05673993 (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: 1 October 2025

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/NCT05673993.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing