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Sjögren Syndrome

2
Pipeline Programs
3
Companies
31
Clinical Trials
16 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
2100%
+ 1 programs with unclassified modality

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
2 programs
2
CFZ533Phase 2
RemibrutinibPhase 2Small Molecule
Novartis
NovartisBASEL, Switzerland
1 program
RemibrutinibPHASE_2Small Molecule5 trials
Active Trials
NCT07222956Not Yet Recruiting20Est. Dec 2030
NCT07811869Recruiting180Est. Jan 2030
NCT07768371Recruiting576Est. Dec 2029
+2 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib

Showing 15 of 31 trials with date data

Clinical Trials (31)

Total enrollment: 14,894 patients across 31 trials

A Study to Evaluate Efficacy, Safety, and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)

Start: Oct 2026Est. completion: Jan 2030180 patients
Phase 3Recruiting

A 52-week Study of Remibrutinib in IgE-mediated Food Allergy

Start: Aug 2026Est. completion: Dec 2029576 patients
Phase 3Recruiting

A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)

Start: Aug 2026Est. completion: Apr 2030180 patients
Phase 3Recruiting

An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS

Start: Jul 2026Est. completion: Oct 2031710 patients
Phase 3Recruiting

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Start: Apr 2026Est. completion: Jan 2033648 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Start: Nov 2025Est. completion: Jan 20341,275 patients
Phase 3Recruiting

A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines

Start: Jul 2025Est. completion: May 2027400 patients
Phase 3Recruiting

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Start: Jun 2025Est. completion: Jun 2031400 patients
Phase 3Recruiting

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

Start: Mar 2025Est. completion: Oct 2027565 patients
Phase 3Active Not Recruiting

A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis

Start: Feb 2025Est. completion: Feb 2033180 patients
Phase 3Recruiting

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)

Start: Jan 2025Est. completion: Oct 2027588 patients
Phase 3Active Not Recruiting

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

Start: Dec 2023Est. completion: Jun 2029362 patients
Phase 3Active Not Recruiting

A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

Start: Apr 2023Est. completion: Apr 2024144 patients
Phase 3Completed

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

Start: Dec 2022Est. completion: Aug 2027696 patients
Phase 3Active Not Recruiting

A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines

Start: Jan 2022Est. completion: Dec 202371 patients
Phase 3Completed

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)

Start: Dec 2021Est. completion: Oct 20301,000 patients
Phase 3Active Not Recruiting

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)

Start: Dec 2021Est. completion: Oct 20301,007 patients
Phase 3Active Not Recruiting

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines

Start: Dec 2021Est. completion: Jan 2024455 patients
Phase 3Completed

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

Start: Nov 2021Est. completion: Jan 2024470 patients
Phase 3Completed

A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS

Start: Mar 2027Est. completion: Dec 203020 patients
Phase 2Not Yet Recruiting

A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

Start: Jul 2026Est. completion: Dec 2027100 patients
Phase 2Recruiting

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

Start: May 2025Est. completion: Sep 202744 patients
Phase 2Recruiting

Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

Start: Oct 2022Est. completion: Mar 202576 patients
Phase 2Completed

A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome

Start: Jul 2019Est. completion: Nov 202173 patients
Phase 2Terminated

A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.

Start: Jul 2025Est. completion: Oct 202516 patients
Phase 1Completed

A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants

Start: Oct 2022Est. completion: Dec 202338 patients
Phase 1Completed

Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.

Start: Aug 2026Est. completion: Aug 203015 patients
N/ARecruiting

Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)

Start: Aug 2026Est. completion: May 2029470 patients
N/ARecruiting

Remibrutinib in Real-world Clinical Practice

Start: Feb 2026Est. completion: Oct 20313,280 patients
N/ARecruiting

Remibrutinib in Real-world Clinical Practice - a US Sub-study

Start: Feb 2026Est. completion: Sep 2029505 patients
N/ARecruiting

A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients

Start: Jan 2026Est. completion: Sep 2026350 patients
N/ARecruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

16 actively recruiting trials targeting 14,894 patients
Small Molecule is the dominant modality (100% of programs)
3 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.