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Primary Sjögren's Syndrome

8
Pipeline Programs
11
Companies
15
Clinical Trials
4 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

10 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
4 programs
1
3
CDZ173Phase 2
CFZ533 active - Cohort 1Phase 2
VAY736Phase 2
VAY736 lower dosePhase 1/2
UCB Pharma
UCB PharmaBelgium - Brussels
2 programs
1
UCB5857Phase 2
UCB5857PHASE_21 trial
Active Trials
NCT02610543Terminated27Est. Dec 2017
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
Innovent Biologics
Innovent BiologicsChina - Jiangsu
1 program
1
IBI355Phase 11 trial
Active Trials
NCT06484855Completed30Est. Jul 2025
IQVIA
IQVIADURHAM, NC
2 programs
EfgartigimodPHASE_2
EfgartigimodPHASE_2
argenx
argenxBelgium - Zwijnaarde
2 programs
EfgartigimodPHASE_25 trials
EfgartigimodPHASE_21 trial
Active Trials
NCT07760818Not Yet Recruiting75Est. Jul 2029
NCT07673627Recruiting40Est. Apr 2028
NCT07782775Completed32Est. Sep 2026
+3 more trials
Novartis
NovartisBASEL, Switzerland
1 program
VAY736 lower dosePHASE_1_21 trial
Active Trials
NCT02495129Withdrawn0Est. Sep 2017
Biogen
BiogenCAMBRIDGE, MA
1 program
BaminerceptPHASE_21 trial
Active Trials
NCT01552681Terminated52Est. Jun 2015
Immunovant
ImmunovantDURHAM, NC
1 program
IMVT-1402PHASE_21 trial
Active Trials
NCT06979531Active Not Recruiting180Est. Jul 2029

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
argenxEfgartigimod
argenxEfgartigimod
argenxEfgartigimod
argenxEfgartigimod
ImmunovantIMVT-1402
argenxEfgartigimod
argenxEfgartigimod
ServierS95011 concentrate for solution for infusion
IncyteParsaclisib
UCB PharmaUCB5857
BiogenBaminercept
NovartisVAY736 lower dose
argenxEfgartigimod
Innovent BiologicsIBI355
argenxEfgartigimod

Clinical Trials (15)

Total enrollment: 1,112 patients across 15 trials

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 3Recruiting
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 3Recruiting
NCT07760818argenxEfgartigimod

A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)

Start: Aug 2026Est. completion: Jul 202975 patients
Phase 2Not Yet Recruiting
NCT07673627argenxEfgartigimod

ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

Start: Jul 2026Est. completion: Apr 202840 patients
Phase 2Recruiting
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 2Active Not Recruiting
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
NCT02610543UCB PharmaUCB5857

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

Start: Oct 2015Est. completion: Dec 201727 patients
Phase 2Terminated
NCT01552681BiogenBaminercept

Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome

Start: Jul 2012Est. completion: Jun 201552 patients
Phase 2Terminated
NCT02495129NovartisVAY736 lower dose

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

Start: Dec 2015Est. completion: Sep 20170
Phase 1/2Withdrawn
NCT07782775argenxEfgartigimod

A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants

Start: Jun 2026Est. completion: Sep 202632 patients
Phase 1Completed
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

4 actively recruiting trials targeting 1,112 patients
11 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.