Chronic Spontaneous Urticaria

15

Review clinical trials related to Chronic Spontaneous Urticaria. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic spontaneous urticaria (CSU) that is not effectively treated by antihistamines which are used to stop the body's "allergy alarm system" from overreacting. Chronic spontaneous urticaria is a disease that causes itchy hives and swellings in the deep layers of skin and fatty tissue just underneath the skin that come and go without a clear reason. This study will look at both the 50 milligrams (mg) once daily (QD) oral dose and 100 milligrams (mg) once daily (QD) oral dose and compare them to placebo (pill with no active medicine). This study is seeking participants who: * Are 18 years of age or older * Have a diagnosis of chronic spontaneous urticaria for 3 months or more that has not been controlled well with antihistamine treatment. * Do not have any other skin conditions associated with chronic itching or itching caused mainly by known triggers. * Are willing to stop all other treatments that they may be taking for chronic spontaneous urticaria other than a second-generation antihistamine (sgAH). About 150 participants will take part in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive either the 50 mg dose or 100 mg dose or placebo, taken by mouth once daily for 12 weeks( Period A). Thereafter the participants on 50 mg and 100 mg will continue on their doses while the participants receiving placebo will be switched to 100mg for an additional 12 weeks (Period B). The 2 doses of ritlecitinib in this study will be compared to each other and to the placebo. This will help to see if the 50 mg and/or 100 mg dose of ritlecitinib is safe and effective. Participants will be in this study for about 8 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: * Physical examinations, * Hearing tests, * Blood tests, * X-ray, * ECG (electrocardiogram), * Participants will also be asked to complete questionnaires every day about their chronic spontaneous urticaria in an electronic diary.

Participants needed: 200
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: PfizerUpdated: Jun 17, 2026Locations: 69
Eligibility criteria

18 years of age or older (or the minimum legal adult age as defined per local re...

Medical conditions pertaining to CSU and other diseases/conditions affecting the... [+24]

Status: Not yet recruiting

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

Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.

Participants needed: 470
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: Novartis PharmaceuticalsUpdated: Jun 11, 2026
Eligibility criteria

Patients with a confirmed diagnosis of primary CSU by the treating physician. [+4]

Simultaneous participation in any investigational trial or simultaneous particip... [+4]

Status: Recruiting

24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up

The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment

Participants needed: 100
Trial details
Phase: Phase 3Age: 12-17Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Jun 5, 2026Locations: 66
Eligibility criteria

Male and female adolescent participants aged >= 12 to < 18 years of age at the t... [+4]

Previous use of remibrutinib or other BTK inhibitors [+9]

Status: Not yet recruiting

A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria

The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for Chronic Spontaneous Urticaria.

Participants needed: 190
Trial details
Phase: Phase 2Age: 18-70Biological sex: AllType: InterventionalSponsor: Chengdu Suncadia Medicine Co., Ltd.Updated: May 29, 2026Locations: 2
Eligibility criteria

Participants must be between 18 and 70 years of age, inclusive, at the time of s... [+7]

Any skin disease that could interfere with study assessment (e.g., chronic induc... [+14]

Status: Recruiting

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

This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.

Participants needed: 350
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: Novartis PharmaceuticalsUpdated: May 11, 2026Locations: 1
Eligibility criteria

Have an active medical license and be board certified/board eligible allergist o... [+3]

≥ 18 years of age. [+10]

Status: Recruiting

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults

This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.

Participants needed: 98
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Enanta Pharmaceuticals, IncUpdated: Apr 21, 2026Locations: 1
Eligibility criteria

An informed consent document signed and dated by the subject. [+1]

Clinically relevant evidence or history of illness or disease. [+8]

Status: Recruiting

Remibrutinib in Real-world Clinical Practice

Prospective, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.

Participants needed: 3,280
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Novartis PharmaceuticalsUpdated: Apr 16, 2026Locations: 1
Eligibility criteria

Patients with a confirmed diagnosis of primary CSU by the treating physician. [+5]

Currently enrolled in a clinical trial or on any experimental treatment. [+4]

Status: Recruiting

A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria

This is a decentralized study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with chronic spontaneous urticaria (CSU). This study will be conducted in the United States and will collect data available from participants' medical files, other items routinely collected during disease management in clinical practice, and patient-reported outcomes related to disease, work productivity, quality of life, and CSU-related hospitalizations. Participation in this study is the patient's own choice and is entirely voluntary. The treating physician prescribes dupilumab treatment as part of routine care, independently of the study. Once the decision to prescribe dupilumab is made by the treating physician, patients can self-screen and will be contacted by the Virtual Research Coordination Center to determine potential study eligibility. Patients will be enrolled if they provide an informed consent and meet all inclusion criteria and none of the exclusion criteria. The duration of the study for each participant is 24 months. All patients will be followed for 24 months or until death, loss to follow-up, or withdrawal, whichever occurs first.

Participants needed: 400
Trial details
Age: 12+Biological sex: AllType: ObservationalSponsor: SanofiUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

Patients aged 12 years or older at the time of informed consent/assent. [+3]

Patients who have a contraindication to dupilumab according to the approved pres... [+3]

Status: Recruiting

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).

Participants needed: 105
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Blueprint Medicines CorporationUpdated: Feb 17, 2026Locations: 47
Eligibility criteria

Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadeq... [+1]

Part A: Any active urticaria that may interfere with study assessments. [+5]

Status: Recruiting

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

Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.

Participants needed: 505
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: Novartis PharmaceuticalsUpdated: Feb 13, 2026Locations: 1
Eligibility criteria

Patients with a confirmed diagnosis of primary CSU by the treating physician. [+5]

Currently enrolled in a clinical trial or on any experimental treatment. [+4]

Status: Not yet recruiting

Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

Participants needed: 180
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: JemincareUpdated: Feb 11, 2026
Eligibility criteria

Male or female participant must be ≥18 years old at the time of signing the info... [+5]

Participants who suffer from inducible urticaria with definite inducements, incl... [+4]

Status: Available

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

The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)

Trial details
Age: 18-99Biological sex: AllType: Expanded AccessSponsor: Novartis PharmaceuticalsUpdated: Dec 5, 2025
Eligibility criteria

Adult male and female subjects (≥ 18 years) who are able and willing to provide... [+3]

Previous premature discontinuation from a remibrutinib clinical trial for any re... [+27]

Status: Recruiting

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

This study is a multicentre, randomized, open-label, non-inferiority clinical trial. The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.

Participants needed: 40
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Simon Francis ThomsenUpdated: Sep 19, 2025Locations: 1
Eligibility criteria

A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines. [+4]

Pregnant or breastfeeding women. [+6]

Status: Not yet recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HS-10561 Capsule in Healthy Chinese Adults and Patients With Chronic Spontaneous Urticaria.

This is a randomized, double-blind, placebo-controlled phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HS-10561 capsule in healthy Chinese adults and patients with chronic spontaneous urticaria.

Participants needed: 150
Trial details
Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.Updated: Mar 7, 2025Locations: 1
Eligibility criteria

Written informed consent must be obtained before any assessment is performed.(SD... [+8]

Have clinically significant abnormalities in vital signs, physical examination,... [+7]

Status: Recruiting

Trial of JYB1904 in Chronic Spontaneous Urticaria.

This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.

Participants needed: 135
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: JemincareUpdated: Nov 29, 2024Locations: 1
Eligibility criteria

Male or female adult subjects (≥18 years of age). [+3]

Induced urticaria with a defined trigger, including artificial urticaria (cutane... [+4]