Chronic Spontaneous Urticaria

Dermatology
19
Pipeline Programs
8
Companies
50
Clinical Trials
11 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
1
5
0
9
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1179%
Small Molecule
321%
+ 8 programs with unclassified modality

On Market (1)

Approved therapies currently available

Novartis
RHAPSIDOApproved
remibrutinib
Novartis
Kinase Inhibitor [EPC]oral2025

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
11 programs
2
4
1
OMALIZUMABPhase 4Monoclonal Antibody1 trial
LigelizumabPhase 3Monoclonal Antibody1 trial
OmalizumabPhase 3Monoclonal Antibody1 trial
RHAPSIDO(Remibrutinib)Phase 3Small Molecule5 trials
omalizumabPhase 3Monoclonal Antibody1 trial
+6 more programs
Active Trials
NCT06991608Active Not Recruiting116Est. Dec 2025
NCT04903613No Longer Available
NCT05170724Available
+18 more trials
Celldex Therapeutics
5 programs
1
1
3
barzolvolimabPhase 3Monoclonal Antibody1 trial
barzolvolimabPhase 3Monoclonal Antibody1 trial
barzolvolimabPhase 3Monoclonal Antibody1 trial
barzolvolimabPhase 2Monoclonal Antibody1 trial
CDX-0159Phase 11 trial
Active Trials
NCT04538794Completed45Est. Jan 2023
NCT05368285Completed208Est. Dec 2024
NCT07256392Recruiting1,370Est. Sep 2028
+2 more trials
Celltrion
CelltrionKorea - Incheon
1 program
1
CT-P39Phase 31 trial
Active Trials
NCT04426890Completed634Est. Apr 2023
Sanofi
SanofiPARIS, France
1 program
1
DupilumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT05526521Completed15Est. Feb 2025
S
SteroTherapeuticsPA - Doylestown
1 program
1
CBDPhase 21 trial
Active Trials
NCT04439955CompletedEst. Jul 2021
GS
Gilead SciencesFOSTER CITY, CA
1 program
1
TirabrutinibPhase 2Small Molecule1 trial
Active Trials
NCT04827589Withdrawn0Est. Sep 2022
Jasper Therapeutics
Jasper TherapeuticsREDWOOD CITY, CA
1 program
1
BriquilimabPhase 1/2Monoclonal Antibody1 trial
Active Trials
NCT06162728Active Not RecruitingEst. Oct 2026
BeOne Medicines
BeOne MedicinesCA - San Carlos
1 program
1
BGB-16673Phase 11 trial
Active Trials
NCT07005713Active Not RecruitingEst. Apr 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
NovartisOMALIZUMAB
NovartisXolair
NovartisRemibrutinib
Celldex Therapeuticsbarzolvolimab
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib
Celldex Therapeuticsbarzolvolimab
Celldex Therapeuticsbarzolvolimab
NovartisRemibrutinib
NovartisRemibrutinib
NovartisRemibrutinib

Showing 15 of 48 trials with date data

Clinical Trials (50)

Total enrollment: 20,134 patients across 50 trials

Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

Start: Apr 2015Est. completion: Jan 2016136 patients
Phase 4Completed

Non-invasive Measures of Effects of Xolair in Asthma

Start: Feb 2009Est. completion: Feb 201113 patients
Phase 4Terminated

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Start: Apr 2026Est. completion: Jan 2033212 patients
Phase 3Not Yet Recruiting

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Start: Nov 2025Est. completion: Sep 20281,370 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

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

Start: Jul 2025Est. completion: Jun 2031360 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

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: Feb 2028555 patients
Phase 3Recruiting

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: Jan 2028555 patients
Phase 3Recruiting

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

Start: Jul 2024Est. completion: Apr 2027976 patients
Phase 3Active Not Recruiting

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Start: Jul 2024Est. completion: Apr 2027963 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

Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.

Start: Nov 2023Est. completion: Jul 2027470 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 Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

Start: Aug 2022Est. completion: Feb 202515 patients
Phase 3Completed

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)

Start: Dec 2021Est. completion: Oct 20301,001 patients
Phase 3Active Not Recruiting

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

Start: Dec 2021Est. completion: Oct 20301,011 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

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

Start: Dec 2020Est. completion: Apr 2023634 patients
Phase 3Completed

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Start: Apr 2020Est. completion: Sep 20221,033 patients
Phase 3Terminated

Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

Start: Apr 2017Est. completion: Sep 2019418 patients
Phase 3Completed

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

Start: Aug 2014Est. completion: Nov 2016314 patients
Phase 3Completed

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

Start: Apr 2026Est. completion: Dec 203020 patients
Phase 2Not Yet Recruiting

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

Start: May 2025Est. completion: Oct 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 of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Start: May 2022Est. completion: Dec 2024208 patients
Phase 2Completed

Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria

Start: Jul 2021Est. completion: Sep 20220
Phase 2Withdrawn

Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

Start: Feb 2020Est. completion: Jul 2021
Phase 2Completed

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Start: Oct 2019Est. completion: Sep 2022229 patients
Phase 2Completed

A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Start: May 2016Est. completion: May 2019226 patients
Phase 2Completed

Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Start: Jul 2015Est. completion: Jun 2017382 patients
Phase 2Completed

Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

Start: Mar 2014Est. completion: Mar 2016270 patients
Phase 2Terminated

Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)

Start: Nov 2023Est. completion: Oct 2026
Phase 1/2Active Not Recruiting

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 Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Adults With Chronic Spontaneous Urticaria

Start: Jul 2025Est. completion: Apr 2026
Phase 1Active Not Recruiting

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

A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Start: Sep 2020Est. completion: Jan 202345 patients
Phase 1Completed

Global Managed Access Program Cohort for Ligelizumab in CSU

N/ANo Longer Available

Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria

N/AAvailable

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: Mar 2026350 patients
N/ARecruiting
NCT06991608NovartisCollection of patient data

A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in Germany

Start: Jun 2024Est. completion: Dec 2025116 patients
N/AActive Not Recruiting

A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China

Start: Feb 2024Est. completion: Aug 202555 patients
N/ACompleted

Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps

Start: Jan 2023Est. completion: Apr 2025135 patients
N/ACompleted

Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies

Start: Jan 2021Est. completion: Nov 202250 patients
N/ACompleted

Related Jobs in Dermatology

Phase Legend

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

Key Insights

9 late-stage (Phase 3) programs — potential near-term approvals
11 actively recruiting trials targeting 20,134 patients
Monoclonal Antibody is the dominant modality (79% of programs)
8 companies competing in this space