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NCT Number: NCT05916937

Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

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.

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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Chronic Urticaria, Idiopathic Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

omalizumab 300 mg every four weeks

Drug

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.

Other names: Standard treatment

omalizumab 300 mg every six weeks

Drug

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.

Other names: Extended treatment

Primary outcomes

  1. Absolute difference in average Urticaria Control Test (UCT) score at week 36

    Time frame: Through study completion, an average of 36 weeks

    The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.

Secondary outcomes

  1. Absolute difference in average Urticaria Control Test (UCT) score at week 24

    Time frame: Through study completion, an average of 36 weeks

    The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.

  2. Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36

    Time frame: Through study completion, an average of 36 weeks

    The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.

  3. Proportion of completely controlled patients (UCT score = 16) at week 24 and 36

    Time frame: Through study completion, an average of 36 weeks

    The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.

  4. Difference in absolute UCT score measured as area under the curve (AUC)

    Time frame: Through study completion, an average of 36 weeks

    The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.

  5. Absolute difference in average weekly urticaria activity score (UAS7) at week 24 and 36

    Time frame: Through study completion, an average of 36 weeks

    The Urticaria Activity Score (UAS) is a score recorded in a diary that assesses the severity of wheals and intensity of pruritus experienced within a 24-hour period. The total UAS score can range from 0 to 6. The UAS7 is calculated by summing the daily UAS scores over the past week. The UAS7 score ranges from 0 to 42, with higher scores indicating greater disease activity. A UAS7 score of less than 7 suggests well-controlled urticaria, while a score of 0 indicates complete control.

  6. Proportion of well-controlled patients (UAS7 score < 7) at week 24 and 36

    Time frame: Through study completion, an average of 36 weeks

    The Urticaria Activity Score (UAS) is a score recorded in a diary that assesses the severity of wheals and intensity of pruritus experienced within a 24-hour period. The total UAS score can range from 0 to 6. The UAS7 is calculated by summing the daily UAS scores over the past week. The UAS7 score ranges from 0 to 42, with higher scores indicating greater disease activity. A UAS7 score of less than 7 suggests well-controlled urticaria, while a score of 0 indicates complete control.

  7. Proportion of completely controlled patients (UAS7 score = 0) at week 24 and 36

    Time frame: Through study completion, an average of 36 weeks

    The Urticaria Activity Score (UAS) is a score recorded in a diary that assesses the severity of wheals and intensity of pruritus experienced within a 24-hour period. The total UAS score can range from 0 to 6. The UAS7 is calculated by summing the daily UAS scores over the past week. The UAS7 score ranges from 0 to 42, with higher scores indicating greater disease activity. A UAS7 score of less than 7 suggests well-controlled urticaria, while a score of 0 indicates complete control.

  8. 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

    The Chronic Urticaria Quality of Life Questionnaire (Cu-QoL) is a retrospective questionnaire that gathers information regarding the past 2 weeks. The Cu-QoL consists of 23 questions, each scored on a scale from 1 (indicating no complaints) to 5 (indicating many complaints). Higher scores on the Cu-QoL reflect a lower quality of life.

  9. Differences in average dermatology life quality index (DLQI) at week 24 and 36

    Time frame: Through study completion, an average of 36 weeks

    The Dermatology Life Quality Index (DLQI) is a validated, self-administered questionnaire consisting of 10 items. It measures the impact of skin disease on patients' quality of life based on their recall of experiences over the past week. The questionnaire covers various domains, including symptoms, feelings, daily activities, social interactions, leisure activities, work or studying, personal relationships, and treatment. Each question is scored on a scale of 0 to 3, resulting in a total score range from 0 (indicating no impact of skin disease on quality of life) to 30 (indicating the maximum impact on quality of life).

  10. Proportion of patients in the two treatment arms who experience flares

    Time frame: Through study completion, an average of 36 weeks

    Flares refer to the exacerbation of symptoms that prompt patients to reach out to their healthcare provider and/or request intensified treatment.

  11. Adverse event (AEs) and serious advese events (SAEs)

    Time frame: Through study completion, an average of 36 weeks

    Adverse events (AEs) encompass any unfavorable and/or unintended signs, incidents, symptoms, or diseases associated with omalizumab. This also includes laboratory results falling outside the reference range, although only laboratory results deemed clinically relevant will be examined. Any AEs occurring from the first administration of the trial medication until 8 days after the last administration of the trial medicine will be documented. Serious adverse events (SAEs) are defined as AEs or adverse reactions that lead to death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity, or involve a congenital anomaly or birth defect.

Study contacts

Contact information is provided by the study sponsor or research team.

Ditte G Zhang, MD

CONTACT

[email protected]

+4520994864

Simon F Thomsen, MD, DMSc

CONTACT

[email protected]

+4526139838

Sponsors and collaborators

Lead sponsor

Simon Francis Thomsen

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: EXOTIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 23, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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