Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria
Recruiting
Phase 4
Interventional Study
Chronic Spontaneous Urticaria
Chronic Urticaria, Idiopathic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Simon Francis Thomsen · Other
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About This 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.
Trial Locations
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Eligibility Criteria
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.
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Contacts