BridgeMD
Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial)
EU CTIS ID: 2023-506187-14-00
What this study is testing
To investigate if adult patients with well controlled chronic spontaneous urticaria (CSU) treated with omalizumab can extend treatment intervals and maintain disease control.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines
- Age ≥ 18 years
- A UCT score ≥ 12 at week 12 after initiating treatment with 300 mg omalizumab every four weeks.
- Omalizumab naïve prior to initiating treatment with omalizumab.
- Background treatment of 4 antihistamines daily
- Type 1 CSU (negative BHRA)
You likely can't join if
- Pregnant or breastfeeding women
- Planned pregnancy within 6 months
- Body mass index (BMI) ≥ 100 kilograms
- Any other active skin disease or condition that may interfere with assessment of CSU e.g., atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis.
- Use of immunosuppressive drugs e.g., prednisolone, azathioprine, methotrexate, and cyclosporine.
- Predominantly symptoms from chronic inducible urticaria (CIndU)
See the full eligibility criteria
- A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines
- Age ≥ 18 years
- A UCT score ≥ 12 at week 12 after initiating treatment with 300 mg omalizumab every four weeks.
- Omalizumab naïve prior to initiating treatment with omalizumab.
- Background treatment of 4 antihistamines daily
- Type 1 CSU (negative BHRA)
- Candidate for omalizumab treatment according to Danish practice
- Pregnant or breastfeeding women
- Planned pregnancy within 6 months
- Body mass index (BMI) ≥ 100 kilograms
- Any other active skin disease or condition that may interfere with assessment of CSU e.g., atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis.
- Use of immunosuppressive drugs e.g., prednisolone, azathioprine, methotrexate, and cyclosporine.
- Predominantly symptoms from chronic inducible urticaria (CIndU)
- Positive BHRA
- Inability to complete study or comply with study procedures
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.