Extending treatment intervals for chronic spontaneous urticaria patients on omalizumab
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
This study is testing if people with well-controlled chronic hives can safely get their omalizumab shots every six weeks instead of every four weeks without their symptoms getting worse.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Drugs / interventions | Omalizumab, methotrexate |
| Locations | 1 site (Copenhagen, Copenhagen N) |
| Trial ID | NCT05916937 on ClinicalTrials.gov |
What this trial studies
This multicentre, randomized, open-label, non-inferiority clinical trial aims to determine if patients with well-controlled chronic spontaneous urticaria (CSU) can safely extend their omalizumab treatment intervals from every four weeks to every six weeks without losing disease control. Patients who have been on omalizumab for 12 weeks and have a UCT score of 12 or higher will be randomized into two groups: one continuing the standard treatment and the other receiving extended intervals. The study will assess the effectiveness and safety of this approach over a 24-week period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic spontaneous urticaria who are naïve to omalizumab and have been well-treated with antihistamines.
Not a fit: Patients with other active skin diseases or those who predominantly experience symptoms from chronic inducible urticaria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could allow patients to reduce the frequency of their treatments while maintaining control of their symptoms.
How similar studies have performed: While the approach of extending treatment intervals is being explored, this specific study is novel in its focus on chronic spontaneous urticaria and omalizumab.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines. * Age ≥ 18 years. * Omalizumab-naïve prior to initiating treatment with omalizumab. * Background treatment with four antihistamines daily. * Candidate for omalizumab treatment according to Danish guidelines. Exclusion Criteria: * Pregnant or breastfeeding women. * Planned pregnancy within the next 6 months. * Weight ≥ 100 kilograms. * Presence of any other active skin disease or condition that may interfere with the assessment of CSU, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis. * Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine. * Predominantly experience symptoms from chronic inducible urticaria (CIndU). * Inability to complete study or comply with study procedures. Patients with a positive basophil histamine release assay (BHRA) are not eligible for the study. Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.
Where this trial is running
Copenhagen, Copenhagen N
- Department of Dermatology, Bispebjerg Hospital — Copenhagen, Copenhagen N, Denmark (Recruiting)
Study contacts
- Study coordinator: Simon F Thomsen, MD, DMSc
- Email: simon.francis.thomsen.02@regionh.dk
- Phone: +4526139838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.