Chronic Spontaneous UrticariaPhase 4EXOTICNCT05916937
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
A Phase 4 study testing omalizumab 300 mg every four weeks and omalizumab 300 mg every six weeks in people with Chronic Spontaneous Urticaria and Chronic Urticaria, Idiopathic, run by Simon Francis Thomsen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria, Chronic Urticaria, Idiopathic
- What is being tested?
- omalizumab 300 mg every four weeks and omalizumab 300 mg every six weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jan 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Copenhagen N, 2100
Simon F Thomsen, DMSc, +4526139838, simon.francis.thomsen.02@regionh.dk
Ditte G Zhang, MD, +4520994864, DZHA0006@regionh.dk
About this study
Official title: Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
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.
Read the 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.
- Being tested
- omalizumab 300 mg every four weeks, omalizumab 300 mg every six weeks
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumab 300 mg every four weeksDrug
Also called Standard treatment
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.
omalizumab 300 mg every six weeksDrug
Also called Extended treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| omalizumab 300 mg every six weeks | Active comparator | 20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36. Receives: Drug: omalizumab 300 mg every six weeks |
| omalizumab 300 mg every four weeks | Active comparator | 20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36. Receives: Drug: omalizumab 300 mg every four weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 36 weeks
Secondary outcomes (11)
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.
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
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).
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
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.
Measured: Through study completion, an average of 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start12 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, open-label, non-inferiority trial.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Francis Thomsen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Simon Francis Thomsen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916937
- Sponsor's protocol ID
- p-2023-14337
- Acronym
- EXOTIC
- Status last verified
- Oct 2024
- First submitted
- 6 Jun 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Danish data protection laws, data sharing is not planned. However, data can be made available upon reasonable request, in compliance with Danish legislation.
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.
PubMed 39762098
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05916937
- Acronym / sponsor ID
- EXOTIC / p-2023-14337
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Simon Francis ThomsenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, open-label, non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| omalizumab 300 mg every six weeks | Active comparator | Drug: omalizumab 300 mg every six weeks20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36. |
| omalizumab 300 mg every four weeks | Active comparator | Drug: omalizumab 300 mg every four weeks20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omalizumab 300 mg every four weeksAlso: Standard treatmentContinue 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 four weeks |
| omalizumab 300 mg every six weeksAlso: Extended treatmentTreatment 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. | Drug | omalizumab 300 mg every six weeks |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 39762098Zhang 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.
- Individual participant dataSharing planned: No. Due to Danish data protection laws, data sharing is not planned. However, data can be made available upon reasonable request, in compliance with Danish legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omalizumab 300 mg every four weeks and omalizumab 300 mg every six weeks in people with Chronic Spontaneous Urticaria and Chronic Urticaria, Idiopathic, run by Simon Francis Thomsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon F Thomsen, MD, DMSc (+4526139838, simon.francis.thomsen.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute difference in average Urticaria Control Test (UCT) score at week 36 (time frame: Through study completion, an average of 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.