TY - JOUR
T1 - EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria (EXOTIC)
T2 - protocol of a multicentre, randomised, open-label, non-inferiority trial
AU - Zhang, Ditte Georgina
AU - Sørensen, Jennifer Astrup
AU - Ghazanfar, Misbah Noshela
AU - Ali, Zarqa
AU - Vestergaard, Christian
AU - Thyssen, Jacob
AU - Egeberg, Alexander
AU - Thomsen, Simon Francis
N1 - © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
PY - 2025
Y1 - 2025
N2 - INTRODUCTION: Omalizumab, an anti-IgE monoclonal antibody, is effective in treating antihistamine-refractory chronic spontaneous urticaria (CSU). However, tapering strategies for omalizumab are currently not well-studied, and patients may be treated longer than needed. Here, we present the rationale and design of the EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria trial, a multicentre, randomised, open-label, non-inferiority clinical trial. The objective of this trial is to investigate if patients with well-controlled CSU, achieved by standard treatment of 300 mg omalizumab administered subcutaneously every 4 weeks (Q4W) for 12 weeks, can maintain disease control with every 6 weeks (Q6W) dosing interval.METHODS AND ANALYSIS: Participants who achieve an Urticaria Control Test (UCT) score ≥12 after 12 weeks on omalizumab will be randomised to 300 mg omalizumab treatment Q4W or Q6W. Treatment arms will be followed for a total of 36 weeks. The primary endpoint is the absolute difference in average UCT score between treatment arms at week 36. Blood samples, Weekly Urticaria Activity Score, Chronic Urticaria Quality of Life Questionnaire, Dermatology Life Quality Index and records of side effects and flares will be obtained throughout the study at weeks 0, 12, 24 and 36.ETHICS AND DISSEMINATION: The study has been approved by the Scientific Ethical Committee of the Capital Region in Denmark, the local Data Protection Agency and the Danish Medicines Agency. All study participants must provide written informed consent. The study will be conducted according to the Helsinki Declaration and Good Clinical Practice. Findings will be disseminated through publication in peer-reviewed journals and presented at international conferences.TRIAL REGISTRATION NUMBER: EU CT no. 2023-506187-14-00, ClinicalTrials.gov: NCT05916937.
AB - INTRODUCTION: Omalizumab, an anti-IgE monoclonal antibody, is effective in treating antihistamine-refractory chronic spontaneous urticaria (CSU). However, tapering strategies for omalizumab are currently not well-studied, and patients may be treated longer than needed. Here, we present the rationale and design of the EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria trial, a multicentre, randomised, open-label, non-inferiority clinical trial. The objective of this trial is to investigate if patients with well-controlled CSU, achieved by standard treatment of 300 mg omalizumab administered subcutaneously every 4 weeks (Q4W) for 12 weeks, can maintain disease control with every 6 weeks (Q6W) dosing interval.METHODS AND ANALYSIS: Participants who achieve an Urticaria Control Test (UCT) score ≥12 after 12 weeks on omalizumab will be randomised to 300 mg omalizumab treatment Q4W or Q6W. Treatment arms will be followed for a total of 36 weeks. The primary endpoint is the absolute difference in average UCT score between treatment arms at week 36. Blood samples, Weekly Urticaria Activity Score, Chronic Urticaria Quality of Life Questionnaire, Dermatology Life Quality Index and records of side effects and flares will be obtained throughout the study at weeks 0, 12, 24 and 36.ETHICS AND DISSEMINATION: The study has been approved by the Scientific Ethical Committee of the Capital Region in Denmark, the local Data Protection Agency and the Danish Medicines Agency. All study participants must provide written informed consent. The study will be conducted according to the Helsinki Declaration and Good Clinical Practice. Findings will be disseminated through publication in peer-reviewed journals and presented at international conferences.TRIAL REGISTRATION NUMBER: EU CT no. 2023-506187-14-00, ClinicalTrials.gov: NCT05916937.
KW - Adult
KW - Female
KW - Humans
KW - Male
KW - Anti-Allergic Agents/therapeutic use
KW - Chronic Urticaria/drug therapy
KW - Drug Administration Schedule
KW - Equivalence Trials as Topic
KW - Multicenter Studies as Topic
KW - Omalizumab/therapeutic use
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Treatment Outcome
KW - Clinical Trials, Phase IV as Topic
U2 - 10.1136/bmjopen-2024-084987
DO - 10.1136/bmjopen-2024-084987
M3 - Journal article
C2 - 39762098
VL - 15
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 1
M1 - e084987
ER -