Spontaneous Urticaria, ChronicINTENXONCT04583475
Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria
An observational study of Spontaneous Urticaria, Chronic, run by University Hospital, Lille at 1 site in France.
Trial summary
This is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of AOM treatment at 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Urticaria, Chronic
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2021to 22 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with SUC, for whom the indication for AOM treatment has been selected.
Who may be able to join
- Patient having expressed non-opposition
- Affiliation to a social protection scheme (beneficiary or entitled person)
- Decision by the investigator to initiate, independently of the study, an AOM treatment for Spontaneous Chronic Urticaria that may or may not be associated with an inducible component.
Who cannot join
- Patients < 18 years of age
- Patient who had previously received AOM treatment prior to the inclusion visit
- Patients under guardianship or curatorship
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of AOM treatment at 3 months.
- Conditions
- Spontaneous Urticaria, Chronic
- Medical subject headings
- Chronic Urticaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients benefiting from an intensification of OMA treatment at 3 months,
defined as an increase in dose (more than 300mg) and/or a reduction in the administration interval to less than 4 weeks.
Measured: At 3 months
Secondary outcomes (7)
Patient characteristics at initiation of OMA treatment expressed as numbers and percentage of total subjects.
Measured: at baseline
Proportion of patients benefiting from an intensification of OMA treatment
Percentage of patients who received an OMA dose greater than 300mg per dose and/or an administration interval of less than 4 weeks apart at 0, 6 and 9 months.
Measured: Baseline, at 6 months and at 9 months
Activity of urticaria (score UCT) composite
- Proportion of patients (numbers and percentage of total) with Satisfactory response (UCT≥12 score)
- Proportion of patients (numbers and percentage of total) with a complete response (UCT=16 score)
- Proportion of patients (numbers and percentage of total) with unsatisfactory response (UCT score<12)
Measured: at 3, 6 and 9 months
Proportion of patients with side effect during follow-up (number and percentage of the total patients)
Measured: at 3, 6 and 9 months
Life Quality
Comparison of the percentage and absolute change in DLQI score (Dermatology Life Quality Index score) versus baseline between patients who received a dose escalation and patients who received a standard dose of OMA.
The DLQI is a dermatology-specific quality of life scale validated in the UCS. It assesses the impact of the disease on different aspects of life such as symptoms, feelings, activities of daily living, leisure, work, school and personal relationships. The total score ranges from 0 to 30 points: 0-1 = No effect of urticaria on the patient's life; between 2-5 = Mild effect of urticaria on the patient's life; between 6-10 = Moderate effect of urticaria on the patient's life; between 11-20 = Very strong effect of urticaria on the patient's life and between 21-30 = Extremely strong effect of urticaria on the patient's life.
Measured: at 3, 6 and 9 months
Life Quality
Comparison of the percentage and absolute change in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score versus baseline between patients who received a dose escalation and patients who received a standard dose of OMA.
The Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) for Chronic Urticaria Quality of Life Questionnaire is a tool specifically designed to assess the quality of life of patients with Chronic Urticaria Syndrome and its variant for angioedema (AE-QoL). It is a 23-item self-administered questionnaire that asks patients to rate how often each problem affects them on a Likert scale with several options (minimum 1: not at all; maximum 5: a lot). Higher scores indicate poorer quality of life.
Measured: at 3, 6 and 9 months
The angioedema activity
Comparison of the percentage and absolute change in AAS28score versus baseline between patients who received a dose escalation and patients who received a standard dose of OMA.
The AAS for angioedema activity score developed by Weller et al. consists of 5 questions to assess the severity of angioedema episodes. A severity grade increasing between 0 and 3 is assigned for each question. The final score corresponds to the sum of the scores for each day over a 28-day period (ASA28) and ranges from 0-420 (ASA28).
Measured: at 3, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start25 Feb 2021
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Urticaria, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine Staumont-Salle, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583475
- Sponsor's protocol ID
- 2019_19
- Other IDs
- 2019-A02662-55
- Acronym
- INTENXO
- Status last verified
- Dec 2025
- First submitted
- 5 Oct 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT04583475
- Acronym / sponsor ID
- INTENXO / 2019_19
- Conditions
- Spontaneous Urticaria, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 12 Oct 2020 (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.
This is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of AOM treatment at 3 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with SUC, for whom the indication for AOM treatment has been selected.
Key inclusion criteria (3 listed)
- Patient having expressed non-opposition
- Affiliation to a social protection scheme (beneficiary or entitled person)
- Decision by the investigator to initiate, independently of the study, an AOM treatment for Spontaneous Chronic Urticaria that may or may not be associated with an inducible component.
Key exclusion criteria (4 listed)
- Patients < 18 years of age
- Patient who had previously received AOM treatment prior to the inclusion visit
- Patients under guardianship or curatorship
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients benefiting from an intensification of OMA treatment at 3 months,
Time frame: At 3 months
defined as an increase in dose (more than 300mg) and/or a reduction in the administration interval to less than 4 weeks.
7 secondary outcomes
Patient characteristics at initiation of OMA treatment expressed as numbers and percentage of total subjects.
Time frame: at baseline
Proportion of patients benefiting from an intensification of OMA treatment
Time frame: Baseline, at 6 months and at 9 months
Activity of urticaria (score UCT) composite
Time frame: at 3, 6 and 9 months
Proportion of patients with side effect during follow-up (number and percentage of the total patients)
Time frame: at 3, 6 and 9 months
Life Quality
Time frame: at 3, 6 and 9 months
Life Quality
Time frame: at 3, 6 and 9 months
The angioedema activity
Time frame: at 3, 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Delphine Staumont-Salle, MD,PhD principal investigator
University Hospital, Lille
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 Spontaneous Urticaria, Chronic, run by University Hospital, Lille 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 23 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients benefiting from an intensification of OMA treatment at 3 months, (time frame: At 3 months). 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 23 Dec 2025.