Pivotal clinical evidence supporting omalizumab-igec (CT-P39) in chronic spontaneous urticaria [30, 31].
| Characteristic | Evidence |
|---|---|
| Study | Phase III, randomized, double-blind, active-controlled equivalence trial [31] |
| Clinical Trials | NCT04426890 |
| Population | 619 adults with H1-antihistamine-refractory CSU |
| Treatment | CT-P39 (omalizumab-igec) 300 mg every 4 weeks |
| Comparator | Reference omalizumab 300 mg every 4 weeks |
| Treatment duration | 24 weeks |
| Follow-up | 16-week |
| Primary endpoint | Change in ISS7 (weekly itch severity score) at week 12 |
| Primary outcome | Primary equivalence endpoint met within the predefined equivalence margin; comparable reduction in ISS7 vs. reference omalizumab (−9.21 vs. −9.98) |
| Secondary outcomes | Comparable improvements in UAS7, DLQI, angioedema activity and other efficacy outcomes between CT-P39 and reference omalizumab |
| Safety | Similar overall incidence of adverse events and serious adverse events |
| Immunogenicity | Comparable anti-drug antibody incidence with no clinically meaningful differences |
| Switching substudy | Single-switch from reference omalizumab to CT-P39 maintained comparable efficacy, safety and immunogenicity |
| Main limitations | One pivotal Phase III equivalence study; absence of multiple-switching data and limited long-term real-world evidence |