Severe chronic urticaria not responding to high-dose omalizumab in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, retrospective observational study conducted in French hospitals led by CHU Besancon. It aims to describe clinical and biological characteristics of patients who remain refractory to high-dose omalizumab and to identify risk factors for non-response. The project plans to include about 70 adults and will cover medical records from January 2020 to December 2026 without requiring additional procedures. Data collection uses existing records and respects patient data privacy. The focus is on documenting alternative treatments and real-world outcomes after treatment failure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where it's running

• CHU Minjoz BESANCON
  Besançon, Franche-comté, France Recruiting

Study contacts

• Principal investigator: Julie CASTAGNA, Dr — CHU Minjoz Besançon
• Study coordinator: Julie CASTAGNA, Dr
• Email: jcastagna@chu-besancon.fr
• Phone: +33381218108

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral Food Challenge After Starting Omalizumab in Food Allergy

  This trial tests whether omalizumab begins to help with food allergy within 2 to 4 weeks after starting treatment in people with a confirmed food allergy.

  Recruiting Phase 4 Johns Hopkins University · Baltimore, Maryland · NCT07845552

• Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

  This trial tests a sequencing plan using remibrutinib and omalizumab to see if it helps adults with chronic spontaneous urticaria that isn’t well controlled by second-generation antihistamines.

  Recruiting at 10 sites Phase 3 Novartis · London, Ontario and 9 other locations · NCT07816328

• Switching to Omlyclo® (omalizumab biosimilar) for adults with chronic spontaneous urticaria or severe allergic asthma

  This will try switching adults who are stable on reference omalizumab to the biosimilar Omlyclo® to see if disease control and patient satisfaction stay the same over 12 months.

  Recruiting Celltrion HealthCare France · Montpellier · NCT07425639

• Omalizumab for people with COPD who are allergic to common indoor allergens

  This trial will test whether monthly injections of omalizumab (Xolair) help people aged 40+ with COPD who are allergic to and exposed to common indoor allergens reduce symptoms or exacerbations.

  Recruiting at 10 sites Phase 2 Johns Hopkins University · Birmingham, Alabama and 22 other locations · NCT07059091

• Omalizumab given by weight for food allergy

  This study will test whether higher, weight-based doses of omalizumab are safe and help people with food allergies, including those with very high allergic antibody (IgE) levels, tolerate their allergens better.

  Recruiting at 3 sites Phase 2 Massachusetts General Hospital · Boston, Massachusetts and 2 other locations · NCT06943534

• Omalizumab to increase tolerance to common food allergens in people with high total IgE

  This trial will test whether omalizumab injections every two weeks for 24 weeks, with an optional 8-week twice-weekly extension, can help people with food allergies and very high total IgE tolerate allergic foods.

  Recruiting Phase 2 Johns Hopkins University · Baltimore, Maryland · NCT06934200

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.