NCT03905525: TWINSS

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

Completed Phase 2 Last updated 15 September 2023

What this trial tests

Phase 2 trial testing CFZ533 in Sjögren Syndrome in 273 participants. Completed in 6 June 2023.

Timeline

1 October 2019

Primary endpoint
28 September 2022

6 June 2023

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	273
Start date	1 October 2019
Primary completion	28 September 2022
Estimated completion	6 June 2023
Sites	71 locations across Italy, Colombia, Japan, South Korea, Netherlands, Russia, Sweden, Portugal

Drugs / interventions tested

• CFZ533 — full drug profile →
• Placebo

Conditions studied

• Sjögren Syndrome — all drugs for Sjögren Syndrome →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Sjögren Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

Publications & conference data

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

1. Molecular basis and therapeutic implications of CD40/CD40L immune checkpoint.
   Tang T, Cheng X, Truong B, Sun L, et al · · 2021 · cited 201× · PMID 33091428 · DOI 10.1016/j.pharmthera.2020.107709
2. Current State of Knowledge on Primary Sjögren's Syndrome, an Autoimmune Exocrinopathy.
   Parisis D, Chivasso C, Perret J, Soyfoo MS, et al · · 2020 · cited 114× · PMID 32698400 · DOI 10.3390/jcm9072299
3. Targeted Immunotherapy for Autoimmune Disease.
   Jung SM, Kim WU. · · 2022 · cited 113× · PMID 35291650 · DOI 10.4110/in.2022.22.e9
4. Progressive genetic modifications of porcine cardiac xenografts extend survival to 9 months.
   Mohiuddin MM, Goerlich CE, Singh AK, Zhang T, et al · · 2022 · cited 108× · PMID 35357044 · DOI 10.1111/xen.12744
5. Cellular rejuvenation: molecular mechanisms and potential therapeutic interventions for diseases.
   Ji S, Xiong M, Chen H, Liu Y, et al · · 2023 · cited 89× · PMID 36918530 · DOI 10.1038/s41392-023-01343-5
6. Atherosclerosis With Immune Checkpoint Inhibitor Therapy: Evidence, Diagnosis, and Management: <i>JACC: CardioOncology</i> State-of-the-Art Review.
   Suero-Abreu GA, Zanni MV, Neilan TG. · · 2022 · cited 67× · PMID 36636438 · DOI 10.1016/j.jaccao.2022.11.011
7. Emerging Therapies in Immune Thrombocytopenia.
   Audia S, Bonnotte B, Bonnotte B. · · 2021 · cited 44× · PMID 33801294 · DOI 10.3390/jcm10051004
8. Safety and efficacy of subcutaneous iscalimab (CFZ533) in two distinct populations of patients with Sjögren's disease (TWINSS): week 24 results of a randomised, double-blind, placebo-controlled, phase 2b dose-ranging study.
   Fisher BA, Mariette X, Papas A, Grader-Beck T, et al · · 2024 · cited 33× · PMID 39096929 · DOI 10.1016/s0140-6736(24)01211-x