Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC)

Simon Francis Thomsen

Status and phase: Enrolling; Phase 4

Conditions: Chronic Urticaria, Idiopathic; Chronic Spontaneous Urticaria

Treatments: Drug: omalizumab 300 mg every four weeks; Drug: omalizumab 300 mg every six weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT05916937

p-2023-14337

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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 Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

omalizumab 300 mg every six weeks

Active Comparator group

Description:

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

Treatment:

Drug: omalizumab 300 mg every six weeks

omalizumab 300 mg every four weeks

Active Comparator group

Description:

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

Treatment:

Drug: omalizumab 300 mg every four weeks