Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: omalizumab 300 mg every four weeks, omalizumab 300 mg every six weeks.
- Who it may be relevant to
- Registry conditions: Chronic Spontaneous Urticaria, Chronic Urticaria, Idiopathic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
Overview
This study is a multicentre, randomized, open-label, non-inferiority clinical trial. The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.
Detailed description
Newly referred patients with CSU who are well-treated (UCT score ≥ 12) 12 weeks after initiating standard treatment with omalizumab 300 mg every four weeks, are randomized into two treatment arms.The first arm will continue standard treatment with omalizumab 300 mg every four weeks for 24 weeks. The second arm will receive treatment in an extended interval of omalizumab 300 mg every six weeks for 24 weeks.
Interventions
- Drug omalizumab 300 mg every four weeks
Continue standard treatment with omalizumab 300 mg every four weeks from week 12 to week 36. Both arms are treated with omalizumab 300 mg from week 0 to week 12. - Drug omalizumab 300 mg every six weeks
Treatment in an extended interval of omalizumab 300 mg every six weeks from week 12 to week 36. Both arms are treated with omalizumab 300 mg from week 0 to week 12.
Primary outcome measures
- Absolute difference in average Urticaria Control Test (UCT) score at week 36 [Time frame: Through study completion, an average of 36 weeks]
Secondary outcome measures (11)
- Absolute difference in average Urticaria Control Test (UCT) score at week 24 [Time frame: Through study completion, an average of 36 weeks]
- Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36 [Time frame: Through study completion, an average of 36 weeks]
- Proportion of completely controlled patients (UCT score = 16) at week 24 and 36 [Time frame: Through study completion, an average of 36 weeks]
- Difference in absolute UCT score measured as area under the curve (AUC) [Time frame: Through study completion, an average of 36 weeks]
- Absolute difference in average weekly urticaria activity score (UAS7) at week 24 and 36 [Time frame: Through study completion, an average of 36 weeks]
- Proportion of well-controlled patients (UAS7 score < 7) at week 24 and 36 [Time frame: Through study completion, an average of 36 weeks]
- Proportion of completely controlled patients (UAS7 score = 0) at week 24 and 36 [Time frame: Through study completion, an average of 36 weeks]
- Differences in average Chronic Urticaria Quality of Life (CU-QoL) at week 24 and 36 [Time frame: Through study completion, an average of 36 weeks]
- Differences in average dermatology life quality index (DLQI) at week 24 and 36 [Time frame: Through study completion, an average of 36 weeks]
- Proportion of patients in the two treatment arms who experience flares [Time frame: Through study completion, an average of 36 weeks]
- Adverse event (AEs) and serious advese events (SAEs) [Time frame: Through study completion, an average of 36 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Dermatology, Bispebjerg Hospital — Copenhagen
Publications
- Zhang DG, Sorensen JA, Ghazanfar MN, Ali Z, Vestergaard C, Thyssen J, Egeberg A, Thomsen SF. EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria (EXOTIC): protocol of a multicentre, randomised, open-label, non-inferiority trial. BMJ Open. 2025 Jan 6;15(1):e084987. doi: 10.1136/bmjopen-2024-084987. PMID 39762098
Identifiers
NCT: NCT05916937 · p-2023-14337