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New treatment option for Chronic Spontaneous Urticaria
Official title Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
ClinicalTrials.gov ID: NCT05916937
What this study is testing
What is omalizumab 300 mg every four weeks?
omalizumab 300 mg every four weeks is an investigational medicine, being studied as a potential treatment for chronic spontaneous urticaria.
Also referred to as Standard treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine.
- Predominantly experience 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.
- Omalizumab-naïve prior to initiating treatment with omalizumab.
- Background treatment with four antihistamines daily.
- Candidate for omalizumab treatment according to Danish guidelines.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Copenhagen N, Denmark
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Copenhagen N, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.