Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria (INTENXO)

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 Overview

• Status: Completed
• Conditions: Spontaneous Urticaria, Chronic

• Study Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Claude Huriez Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

all patients with SUC, for whom the indication for AOM treatment has been selected.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristics at initiation of OMA treatment expressed as numbers and percentage of total subjects.		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.	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)	at 3, 6 and 9 months
Proportion of patients with side effect during follow-up (number and percentage of the total patients)		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.	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.	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).	at 3, 6 and 9 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Delphine Staumont-Salle, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria
• Other Study ID Numbers: 2019_19; 2019-A02662-55 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No