Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria

NCT05916937 | Recruiting Phase 4 DMC

• 1 other identifier: p-2023-14337
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Spontaneous Urticaria; Chronic Urticaria, Idiopathic

Outcome Measures

Primary Outcomes (1)

• Absolute difference in average Urticaria Control Test (UCT) score at week 36

  The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.

  Through study completion, an average of 36 weeks

Secondary Outcomes (11)

• Absolute difference in average Urticaria Control Test (UCT) score at week 24

  Through study completion, an average of 36 weeks

• Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36

  Through study completion, an average of 36 weeks

• Proportion of completely controlled patients (UCT score = 16) at week 24 and 36

  Through study completion, an average of 36 weeks

• Difference in absolute UCT score measured as area under the curve (AUC)

  Through study completion, an average of 36 weeks

• Absolute difference in average weekly urticaria activity score (UAS7) at week 24 and 36

  Through study completion, an average of 36 weeks

Study Arms (2)

omalizumab 300 mg every six weeks

ACTIVE COMPARATOR

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

Drug: omalizumab 300 mg every six weeks

omalizumab 300 mg every four weeks

ACTIVE COMPARATOR

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

Drug: omalizumab 300 mg every four weeks

Interventions

omalizumab 300 mg every four weeks 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.

Also known as: Standard treatment

omalizumab 300 mg every four weeks

omalizumab 300 mg every six weeks 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.

Also known as: Extended treatment

omalizumab 300 mg every six weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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, 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.

Sponsors & Collaborators

• Simon Francis Thomsen: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, Copenhagen N, 2100, Denmark

RECRUITING

Related Publications (1)

• Zhang DG, Sorensen JA, Ghazanfar MN, Ali Z, Vestergaard C, Thyssen J, Egeberg A, Thomsen SF. EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria (EXOTIC): protocol of a multicentre, randomised, open-label, non-inferiority trial. BMJ Open. 2025 Jan 6;15(1):e084987. doi: 10.1136/bmjopen-2024-084987.

  PMID: 39762098 DERIVED

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Central Study Contacts

Simon F Thomsen, MD, DMSc

CONTACT

+4526139838; simon.francis.thomsen.02@regionh.dk

Ditte G Zhang, MD

CONTACT

+4520994864; DZHA0006@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DM, PhD, DMSc

Model Details: Multicenter, randomized, open-label, non-inferiority trial.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 23, 2023
• Study Start: January 12, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)