Back to resultsExtending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC)
Primary Purpose
Chronic Spontaneous Urticaria, Chronic Urticaria, Idiopathic
Status
Not yet recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
omalizumab 300 mg every four weeks
omalizumab 300 mg every six weeks
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria
Eligibility Criteria
Inclusion Criteria: Diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines Age ≥ 18 years Urticaria Control Test (UCT) score ≥ 12 at week 12 after initiating treatment with 300 mg of omalizumab every four weeks. Omalizumab-naïve prior to initiating treatment. Background treatment with four antihistamines daily. Type I CSU (negative basophil histamine release assay - BHRA). Identified as a candidate for omalizumab treatment according to Danish practice. Exclusion Criteria: Pregnant or breastfeeding women Planned pregnancy within the next 6 months. Body mass index (BMI) ≥ 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 experiencing symptoms from chronic inducible urticaria (CIndU). Positive basophil histamine release assay (BHRA). Inability to complete the study or comply with study procedures.
Sites / Locations
- Department of Dermatology, Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
omalizumab 300 mg every six weeks
omalizumab 300 mg every four weeks
Arm Description
20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36.
20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36.
Outcomes
Primary Outcome Measures
Absolute difference in average Urticaria Control Test (UCT) score at week 36
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 Outcome Measures
Absolute difference in average Urticaria Control Test (UCT) score at week 24
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.
Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36
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.
Proportion of completely controlled patients (UCT score = 16) at week 24 and 36
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.
Difference in absolute UCT score measured as area under the curve (AUC)
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.
Absolute difference in average weekly urticaria activity score (UAS7) at week 24 and 36
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.
Proportion of well-controlled patients (UAS7 score < 7) at week 24 and 36
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.
Proportion of completely controlled patients (UAS7 score = 0) at week 24 and 36
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.
Differences in average Chronic Urticaria Quality of Life (CU-QoL) at week 24 and 36
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.
Differences in average dermatology life quality index (DLQI) at week 24 and 36
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).
Proportion of patients in the two treatment arms who experience flares
Flares refer to the exacerbation of symptoms that prompt patients to reach out to their healthcare provider and/or request intensified treatment.
Adverse event (AEs) and serious advese events (SAEs)
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.
Full Information
NCT ID
NCT05916937
First Posted
June 6, 2023
Last Updated
June 21, 2023
Sponsor
Simon Francis Thomsen
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05916937
Brief Title
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
Acronym
EXOTIC
Official Title
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Simon Francis Thomsen
Collaborators
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria, Chronic Urticaria, Idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized, open-label, non-inferiority trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
omalizumab 300 mg every six weeks
Arm Type
Active Comparator
Arm Description
20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36.
Arm Title
omalizumab 300 mg every four weeks
Arm Type
Active Comparator
Arm Description
20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36.
Intervention Type
Drug
Intervention Name(s)
omalizumab 300 mg every four weeks
Other Intervention Name(s)
Standard treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
omalizumab 300 mg every six weeks
Other Intervention Name(s)
Extended treatment
Intervention Description
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 Measure Information:
Title
Absolute difference in average Urticaria Control Test (UCT) score at week 36
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Secondary Outcome Measure Information:
Title
Absolute difference in average Urticaria Control Test (UCT) score at week 24
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Title
Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Title
Proportion of completely controlled patients (UCT score = 16) at week 24 and 36
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Title
Difference in absolute UCT score measured as area under the curve (AUC)
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Title
Absolute difference in average weekly urticaria activity score (UAS7) at week 24 and 36
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Title
Proportion of well-controlled patients (UAS7 score < 7) at week 24 and 36
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Title
Proportion of completely controlled patients (UAS7 score = 0) at week 24 and 36
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Title
Differences in average Chronic Urticaria Quality of Life (CU-QoL) at week 24 and 36
Description
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.
Time Frame
Through study completion, an average of 36 weeks
Title
Differences in average dermatology life quality index (DLQI) at week 24 and 36
Description
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).
Time Frame
Through study completion, an average of 36 weeks
Title
Proportion of patients in the two treatment arms who experience flares
Description
Flares refer to the exacerbation of symptoms that prompt patients to reach out to their healthcare provider and/or request intensified treatment.
Time Frame
Through study completion, an average of 36 weeks
Title
Adverse event (AEs) and serious advese events (SAEs)
Description
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.
Time Frame
Through study completion, an average of 36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines
Age ≥ 18 years
Urticaria Control Test (UCT) score ≥ 12 at week 12 after initiating treatment with 300 mg of omalizumab every four weeks.
Omalizumab-naïve prior to initiating treatment.
Background treatment with four antihistamines daily.
Type I CSU (negative basophil histamine release assay - BHRA).
Identified as a candidate for omalizumab treatment according to Danish practice.
Exclusion Criteria:
Pregnant or breastfeeding women
Planned pregnancy within the next 6 months.
Body mass index (BMI) ≥ 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 experiencing symptoms from chronic inducible urticaria (CIndU).
Positive basophil histamine release assay (BHRA).
Inability to complete the study or comply with study procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon F Thomsen, MD, DMSc
Phone
+4526139838
Email
simon.francis.thomsen.02@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ditte G Zhang, MD
Phone
+4520994864
Email
DZHA0006@regionh.dk
Facility Information:
Facility Name
Department of Dermatology, Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen N
ZIP/Postal Code
2100
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon F Thomsen, DMSc
Phone
+4526139838
Email
simon.francis.thomsen.02@regionh.dk
First Name & Middle Initial & Last Name & Degree
Ditte G Zhang, MD
Phone
+4520994864
Email
DZHA0006@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due to Danish data protection law sharing IPD is not planned. Data outcomes should be anonymized without any recognizable information.
Learn more about this trial
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
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