Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Spontaneous Urticaria Chronic Urticaria, Idiopathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, randomized, open-label, non-inferiority trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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omalizumab 300 mg every six weeks

20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36.

Group Type ACTIVE_COMPARATOR

omalizumab 300 mg every six weeks

Intervention Type DRUG

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.

omalizumab 300 mg every four weeks

20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36.

Group Type ACTIVE_COMPARATOR

omalizumab 300 mg every four weeks

Intervention Type DRUG

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.

Interventions

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omalizumab 300 mg every four weeks

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

omalizumab 300 mg every six weeks

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.

Intervention Type DRUG

Other Intervention Names

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Standard treatment Extended treatment

Eligibility Criteria

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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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No