Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

Официальное название

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Absolute difference in average Urticaria Control Test (UCT) score at week 36 [Срок оценки: Through study completion, an average of 36 weeks]

Вторичные конечные точки (11)

• Absolute difference in average Urticaria Control Test (UCT) score at week 24 [Срок оценки: Through study completion, an average of 36 weeks]
• Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36 [Срок оценки: Through study completion, an average of 36 weeks]
• Proportion of completely controlled patients (UCT score = 16) at week 24 and 36 [Срок оценки: Through study completion, an average of 36 weeks]
• Difference in absolute UCT score measured as area under the curve (AUC) [Срок оценки: Through study completion, an average of 36 weeks]
• Absolute difference in average weekly urticaria activity score (UAS7) at week 24 and 36 [Срок оценки: Through study completion, an average of 36 weeks]
• Proportion of well-controlled patients (UAS7 score < 7) at week 24 and 36 [Срок оценки: Through study completion, an average of 36 weeks]
• Proportion of completely controlled patients (UAS7 score = 0) at week 24 and 36 [Срок оценки: Through study completion, an average of 36 weeks]
• Differences in average Chronic Urticaria Quality of Life (CU-QoL) at week 24 and 36 [Срок оценки: Through study completion, an average of 36 weeks]
• Differences in average dermatology life quality index (DLQI) at week 24 and 36 [Срок оценки: Through study completion, an average of 36 weeks]
• Proportion of patients in the two treatment arms who experience flares [Срок оценки: Through study completion, an average of 36 weeks]
• Adverse event (AEs) and serious advese events (SAEs) [Срок оценки: Through study completion, an average of 36 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Department of Dermatology, Bispebjerg Hospital — Copenhagen

Публикации

• 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

Идентификаторы

NCT: NCT05916937 · p-2023-14337

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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