Trial reportAllergy2025
CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study.
Trial report in Allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04426890 (A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment), which is not on this map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment
Who cites it
10 citing papers in PubMed.
- Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe.Immunotherapy · 2025Trial
- Targeting immune dysregulation in chronic spontaneous urticaria: beyond antihistamines.The Korean journal of internal medicine · 2026Review
- Immunological Basis of Chronic Spontaneous Urticaria: Immunoglobulin E and Beyond.Yonsei medical journal · 2026Review
- Emerging IgE and non-IgE targeted therapies for chronic urticaria.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2026Review
- Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond.The journal of allergy and clinical immunology. In practice · 2026Review
- CT-P39: An Omalizumab Biosimilar.Clinical drug investigation · 2026Review
- Expanding Horizons in Severe Asthma: Anti-IgE Biosimilars and the Redefinition of Patient Selection.Allergy, asthma & immunology research · 2026Article
- Treatments and Targets to Achieve Disease Control in Chronic Spontaneous Urticaria: Current and Emerging Therapeutic Options.Journal of inflammation research · 2026Review
- Autoallergy and what the Allergist Needs to know.Current allergy and asthma reports · 2025Review
- Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16-week follow-up study.Clinical and translational allergy · 2025Article
Corrections and comments
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Authors and funding
17 authors.
Funding
Abstract
backgroundThis study compared the therapeutic equivalence of CT-P39 (an omalizumab biosimilar) and EU-approved reference omalizumab (ref-OMA) in patients with chronic spontaneous urticaria.
methodsThis double-blind, randomized, active-controlled Phase 3 study (NCT04426890) included two 12-week treatment periods (TPs). In TP1, patients received CT-P39 300 mg, ref-OMA 300 mg, CT-P39 150 mg, or ref-OMA 150 mg. In TP2, patients treated with ref-OMA 300 mg were rerandomized to CT-P39 300 mg or ref-OMA 300 mg; patients initially randomized to CT-P39 300 mg continued this regimen; and patients initially randomized to CT-P39 or ref-OMA 150 mg received 300 mg dosing with the same drug. The primary endpoint for the assessment of therapeutic equivalence of CT-P39 300 mg and ref-OMA 300 mg was change from baseline in weekly itch severity score (ISS7) at week 12.
resultsIn TP1, 619 patients were randomized (CT-P39 300 mg, n = 204; ref-OMA 300 mg, n = 205; CT-P39 150 mg, n = 107; ref-OMA 150 mg, n = 103). Equivalence was demonstrated between CT-P39 300 mg and ref-OMA 300 mg for mean change from baseline in ISS7 at week 12; confidence intervals (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 was comparable across groups. Secondary efficacy, quality of life, pharmacokinetic, safety, and immunogenicity outcomes were comparable between groups at a given dose level, with no evident impact of switching.
conclusionsEquivalent efficacy was observed between CT-P39 and ref-OMA, with comparable safety also evident.
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