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Primary Sjögren's Syndrome

8
Pipeline Programs
12
Companies
14
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
6
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 15 programs with unclassified modality

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
4 programs
1
3
CDZ173Phase 21 trial
CFZ533 active - Cohort 1Phase 21 trial
VAY736Phase 21 trial
VAY736 lower dosePhase 1/21 trial
Active Trials
NCT02495129Withdrawn0Est. Sep 2017
NCT02775916Completed30Est. May 2017
NCT02291029Completed69Est. Jun 2018
+1 more trials
Incyte
IncyteDE - Wilmington
1 program
1
ParsaclisibPhase 2Small Molecule1 trial
Active Trials
NCT03627065Completed10Est. Jan 2020
Servier
ServierFrance - Suresnes
1 program
1
S95011 concentrate for solution for infusionPhase 21 trial
Active Trials
NCT04605978Completed48Est. May 2023
UCB-Celltech
UCB-CelltechUK - Slough
1 program
1
UCB5857Phase 21 trial
Active Trials
NCT02610543Terminated27Est. Dec 2017
Innovent Biologics
Innovent BiologicsChina - Jiangsu
1 program
1
IBI355Phase 11 trial
Active Trials
NCT06484855Completed30Est. Jul 2025
argenx
argenxBelgium - Zwijnaarde
2 programs
EfgartigimodPHASE_21 trial
EfgartigimodPHASE_24 trials
Active Trials
NCT05817669Completed34Est. Feb 2024
NCT07596849Not Yet Recruiting230Est. May 2030
NCT07570316Not Yet Recruiting230Est. May 2030
+2 more trials
IQVIA
IQVIADURHAM, NC
2 programs
EfgartigimodPHASE_2
EfgartigimodPHASE_2
Novartis
NovartisBASEL, Switzerland
1 program
VAY736 lower dosePHASE_1_2
Biogen
BiogenCAMBRIDGE, MA
1 program
BaminerceptPHASE_2
Immunovant
ImmunovantDURHAM, NC
1 program
IMVT-1402PHASE_21 trial
Active Trials
NCT06979531Recruiting180Est. Jul 2029
UCB Pharma
UCB PharmaBelgium - Brussels
1 program
UCB5857PHASE_2

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
argenxEfgartigimod
argenxEfgartigimod
ImmunovantIMVT-1402
argenxEfgartigimod
argenxEfgartigimod
ServierS95011 concentrate for solution for infusion
IncyteParsaclisib
SandozCDZ173
UCB-CelltechUCB5857
SandozCFZ533 active - Cohort 1
SandozVAY736
SandozVAY736 lower dose
Innovent BiologicsIBI355
argenxEfgartigimod

Clinical Trials (14)

Total enrollment: 1,039 patients across 14 trials

NCT07570316argenxEfgartigimod

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease

Start: Jun 2026Est. completion: May 2030230 patients
Phase 3Not Yet Recruiting
NCT07596849argenxEfgartigimod

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.

Start: Jun 2026Est. completion: May 2030230 patients
Phase 3Not Yet Recruiting
NCT06979531ImmunovantIMVT-1402

Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

Start: Jun 2025Est. completion: Jul 2029180 patients
Phase 2Recruiting
NCT06203457argenxEfgartigimod

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Start: Nov 2023Est. completion: Feb 202524 patients
Phase 2Completed
NCT05817669argenxEfgartigimod

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Start: Apr 2023Est. completion: Feb 202434 patients
Phase 2Completed
NCT04605978ServierS95011 concentrate for solution for infusion

Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Start: Aug 2021Est. completion: May 202348 patients
Phase 2Completed
NCT03627065IncyteParsaclisib

A Study of INCB050465 in Primary Sjögren's Syndrome

Start: Feb 2019Est. completion: Jan 202010 patients
Phase 2Completed
NCT02775916SandozCDZ173

Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome

Start: Jun 2016Est. completion: May 201730 patients
Phase 2Completed
NCT02610543UCB-CelltechUCB5857

UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome

Start: Oct 2015Est. completion: Dec 201727 patients
Phase 2Terminated
NCT02291029SandozCFZ533 active - Cohort 1

Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

Start: Oct 2014Est. completion: Jun 201869 patients
Phase 2Completed
NCT02149420SandozVAY736

PD of VAY736 in Patients With Primary Sjögren's Syndrome

Start: May 2014Est. completion: Feb 201827 patients
Phase 2Completed
NCT02495129SandozVAY736 lower dose

Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome

Start: Dec 2015Est. completion: Sep 20170
Phase 1/2Withdrawn
NCT06484855Innovent BiologicsIBI355

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome

Start: Jul 2024Est. completion: Jul 202530 patients
Phase 1Completed
NCT07595653argenxEfgartigimod

A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy

Start: Feb 2026Est. completion: Jul 2028100 patients
N/ARecruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 actively recruiting trials targeting 1,039 patients
12 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.