Photo Credit: Eik Scott
The following is a summary of “CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study,” published in the January 2025 issue of Allergy and Immunology by Saini et al.
Researchers conducted a retrospective study comparing CT-P39 and reference omalizumab (ref-OMA), finding equivalent efficacy and safety in patients with chronic spontaneous urticaria.
They conducted a double-blind, randomized, active-controlled phase 3 study (NCT04426890) with 2 12-week treatment periods (TPs). Patients received CT-P39 300 mg, ref-OMA 300 mg, CT-P39 150 mg, or ref-OMA 150 mg in TP1, followed by adjusted regimens in TP2. The primary endpoint was the weekly itch severity score (ISS7) change from baseline at week 12.
The results showed equivalence between CT-P39 300 mg (n = 204) and ref-OMA 300 mg (n = 205) for mean change in ISS7 at week 12, with 619 patients in total. CIs were within predefined equivalence margins: global analysis: treatment difference 0.77, 95% CI –0.37 to 1.90; US analysis: treatment difference 0.70, 90% CI –0.22 to 1.63. The proportion of patients experiencing ≥ 1 treatment-related adverse event (TRAE) was comparable across groups. Secondary outcomes were also comparable between groups.
Investigators observed equivalent efficacy and safety between CT-P39 and ref-OMA.
Source: onlinelibrary.wiley.com/doi/full/10.1111/all.16446
