Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)OMADROPNCT07833696
Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.
An observational study of Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU), run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study is sponsored by the University Hospital of Besancon under the coordination of Dr. Julie Castagna from the Department of Dermatology and Allergology. Approximately ten percent of patients with severe chronic urticaria remain refractory to standard or optimized biologic therapy, and this observational… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
- What is being tested?
- drug effect
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: multicenter recruitment in hospitals in france
Who may be able to join
- Patients with severe chronic urticaria resistant to optimized OMALIZUMAB (600 mg every 2 weeks) with an UCT score < 6 or less than 50% clinical improvement according to the investigator's assessment.
- Men and women aged 18 to 80 years inclusive.
- Subjects who do not object to the use of their personal data and/or biological samples.
- Affiliation with or beneficiary of a French social security scheme.
Who cannot join
- description of the characteristics and management of patients with severe chronic spontaneous and/or inducible urticaria experiencing failure of treatment with optimized omalizumab
- patients with severe chronic urticaria resistant to optimized omalizumab (600 mg every 2 weeks) with an uct score < 6 or less than 50% clinical improvement according to the investigator's assessment
- men and women aged 18 to 80 years inclusive
- subjects who do not object to the use of their personal data and/or biological samples
- affiliation with or beneficiary of a french social security scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Minjoz BESANCON
Besançon, Franche-comté, 25000
Julie CASTAGNA, Dr, +33381218108, jcastagna@chu-besancon.fr
About this study
The study is sponsored by the University Hospital of Besancon under the coordination of Dr. Julie Castagna from the Department of Dermatology and Allergology. Approximately ten percent of patients with severe chronic urticaria remain refractory to standard or optimized biologic therapy, and this observational multicenter retrospective project aims to thoroughly evaluate these challenging cases. By analyzing a target population of seventy adult participants across French hospitals, the research focuses on identifying specific clinical and biological traits, outlining risk factors associated with non-response to high-dose treatment regimens, and documenting the alternative therapeutic strategies that follow treatment failure. Data collection is structured retrospectively to cover the period from January 2020 through the end of December 2026, leveraging existing medical records without imposing any additional clinical visits or physical procedures on participants, aside from sending an informational mailer to ensure transparency regarding data utilization. Eligibility requires documented resistance to optimized omalizumab defined by a validated Urticaria Control Test score below six or less than fifty percent clinical improvement as judged by the investigator, alongside mandatory affiliation with the French social security scheme and a lack of objection from the participant regarding the secondary use of their personal health information. Strictly enforced exclusion conditions eliminate cases where omalizumab was initiated for alternative diagnoses, halted due to adverse side effects, or administered to vulnerable groups such as pregnant individuals, minors, or those under legal protection frameworks. To maintain absolute data integrity and regulatory compliance, individual participant data will not be shared publicly or externally because the documentation contains confidential and fully anonymized clinical details designed strictly to safeguard patient privacy throughout the research lifecycle.
- Conditions
- Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
- Being tested
- drug effect
- Keywords
- omalizumab, omalizumab-resistant patients, chronic urticaria
- Medical subject headings
- Chronic Urticaria, Chronic Inducible Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug effectDrug
description of the characteristics and management of patients with severe chronic spontaneous and/or inducible urticaria experiencing failure of treatment with optimized omalizumab
| Study group | Role | What they receive |
|---|---|---|
| non responders | Patients with chronic spontaneous or inducible urticaria resistant to optimized omalizumab treatment at 600 mg every 15 days. Receives: Drug: drug effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing known risk factors for omalizumab resistance.
Describe the clinical and biological characteristics of patients with chronic urticaria resistant to optimized omalizumab
Measured: Data collection between 2020 and the end of 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie CASTAGNA, Centre Hospitalier Universitaire de Besancon
- Investigators
- Julie CASTAGNA, Dr, Principal investigator, CHU Minjoz Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833696
- Sponsor's protocol ID
- 2026/1059
- Acronym
- OMADROP
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the individual participant data will not be shared because it contains confidential and anonymized information to protect patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.
- ClinicalTrials.gov ID
- NCT07833696
- Acronym / sponsor ID
- OMADROP / 2026/1059
- Conditions
- Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
- Keywords
- omalizumab, omalizumab-resistant patients, chronic urticaria
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is sponsored by the University Hospital of Besancon under the coordination of Dr. Julie Castagna from the Department of Dermatology and Allergology. Approximately ten percent of patients with severe chronic urticaria remain refractory to standard or optimized biologic therapy, and this observational multicenter retrospective project aims to thoroughly evaluate these challenging cases. By analyzing a target population of seventy adult participants across French hospitals, the research focuses on identifying specific clinical and biological traits, outlining risk factors associated with non-response to high-dose treatment regimens, and documenting the alternative therapeutic strategies that follow treatment failure. Data collection is structured retrospectively to cover the period from January 2020 through the end of December 2026, leveraging existing medical records without imposing any additional clinical visits or physical procedures on participants, aside from sending an informational mailer to ensure transparency regarding data utilization. Eligibility requires documented resistance to optimized omalizumab defined by a validated Urticaria Control Test score below six or less than fifty percent clinical improvement as judged by the investigator, alongside mandatory affiliation with the French social security scheme and a lack of objection from the participant regarding the secondary use of their personal health information. Strictly enforced exclusion conditions eliminate cases where omalizumab was initiated for alternative diagnoses, halted due to adverse side effects, or administered to vulnerable groups such as pregnant individuals, minors, or those under legal protection frameworks. To maintain absolute data integrity and regulatory compliance, individual participant data will not be shared publicly or externally because the documentation contains confidential and fully anonymized clinical details designed strictly to safeguard patient privacy throughout the research lifecycle.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non responders | – | Drug: drug effectPatients with chronic spontaneous or inducible urticaria resistant to optimized omalizumab treatment at 600 mg every 15 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- multicenter recruitment in hospitals in france
Key inclusion criteria (4 listed)
- Patients with severe chronic urticaria resistant to optimized OMALIZUMAB (600 mg every 2 weeks) with an UCT score < 6 or less than 50% clinical improvement according to the investigator's assessment.
- Men and women aged 18 to 80 years inclusive.
- Subjects who do not object to the use of their personal data and/or biological samples.
- Affiliation with or beneficiary of a French social security scheme.
Key exclusion criteria (5 listed)
- description of the characteristics and management of patients with severe chronic spontaneous and/or inducible urticaria experiencing failure of treatment with optimized omalizumab
- patients with severe chronic urticaria resistant to optimized omalizumab (600 mg every 2 weeks) with an uct score < 6 or less than 50% clinical improvement according to the investigator's assessment
- men and women aged 18 to 80 years inclusive
- subjects who do not object to the use of their personal data and/or biological samples
- affiliation with or beneficiary of a french social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug effectdescription of the characteristics and management of patients with severe chronic spontaneous and/or inducible urticaria experiencing failure of treatment with optimized omalizumab | Drug | non responders |
Primary outcome
Proportion of patients showing known risk factors for omalizumab resistance.
Time frame: Data collection between 2020 and the end of 2026
Describe the clinical and biological characteristics of patients with chronic urticaria resistant to optimized omalizumab
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. the individual participant data will not be shared because it contains confidential and anonymized information to protect patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie CASTAGNA, Dr principal investigator
CHU Minjoz Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU), run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie CASTAGNA, Dr (+33381218108, jcastagna@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients showing known risk factors for omalizumab resistance. (time frame: Data collection between 2020 and the end of 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.