Early access
Sign in
CompletedPhase 4

Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial)

Key facts

Who runs it
Bispebjerg Hospital
Where
Denmark2 sites in 1 countryChoose a country to see its sites
Status
Completed
Phase
Phase 4
People taking part
40 people enrolled
Started
12 Jan 2024
Ended
9 Jan 2026
Type of study
Interventional
Record updated
13 June 2025

Who can take part

Age
18 years to 64 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines
  • Age ≥ 18 years
  • A UCT score ≥ 12 at week 12 after initiating treatment with 300 mg omalizumab every four weeks
  • Omalizumab naïve prior to initiating treatment with omalizumab
  • Background treatment of 4 antihistamines daily
  • Type 1 CSU (negative BHRA)
  • Candidate for omalizumab treatment according to Danish practice

Who cannot take part

  • Use of immunosuppressive drugs e.g., prednisolone, azathioprine, methotrexate, and cyclosporine
  • Any other active skin disease or condition that may interfere with assessment of CSU e.g., atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis
  • Pregnant or breastfeeding women
  • Planned pregnancy within 6 months
  • Body mass index (BMI) ≥ 100 kilograms
  • Predominantly symptoms from chronic inducible urticaria (CIndU)
  • Positive BHRA
  • Inability to complete study or comply with study procedures

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

To investigate if adult patients with well controlled chronic spontaneous urticaria (CSU) treated with omalizumab can extend treatment intervals and maintain disease control.

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial): a multicentre, randomized, open-label, non-inferiority trial.
Publications
Record updated
13 June 2025