the evaluation of efficacy of low-dose omalizumab in patients with antihistamine-refractory chronic spontaneous urticaria

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250707066393N1

Enrollment

Registered

2025-07-19

Start date

2025-07-21

Completion date

Unknown

Last updated

2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic non-spontaneous urticaria. Other urticaria

Interventions

Intervention 1: Intervention group1:A group that received a dose of 150 mg of omalizumab (a monoclonal antibody against IgE with the Iranian brand name Zerafil from the Cinagen factory) injected subcu

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >12 year No response to 4-fold Anti-histamine (2 Generation) minimal reception of 6 doses of omalizumab monthly Having informed consent

Exclusion criteria

Exclusion criteria: Pregnancy Other Chronic Urticaria Immuno Deficiency

Design outcomes

Primary

Measure	Time frame
The primary outcome includes complete control of chronic spontaneous urticaria, defined as a score of 16 on the UCT questionnaire. Timepoint: 4,8,12,16 and 20 Week after Monthly Injection. Method of measurement: Urticaria Control Test Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSakineh Rezazadeh Mehrizi

Shiraz University of Medical Sciences

rezazadehs17017@gmail.com+98 71 3230 5410

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026