Trial reportAllergy2026
Long-Term Efficacy and Safety of Ligelizumab as Re-Treatment in Patients With Chronic Spontaneous Urticaria.
Trial report in Allergy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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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.
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Who cites it
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Corrections and comments
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Authors and funding
23 authors.
Funding
Abstract
backgroundChronic spontaneous urticaria (CSU) is a debilitating skin condition affecting approximately 1% of the global population, characterized by recurrent wheals, angioedema, or both for over 6 weeks without identifiable external triggers.
methodsThis Phase 3b multicentre, double-blinded followed by open-label extension study evaluated the long-term efficacy and safety of ligelizumab re-treatment in patients with CSU who rolled over from previous studies. Patients from the PEARL-1 or PEARL-2 Phase 3 trials (re-treatment subpopulation) received blinded re-treatment with ligelizumab 72 mg or 120 mg every 4 weeks for 12 weeks, followed by open-label ligelizumab 120 mg up to Week 104. Patients from a Phase 3 open-label Japanese study or a Phase 2 pediatric study received open-label ligelizumab 120 mg throughout. Primary and key secondary efficacy endpoints were assessed at Week 12 in the re-treatment subpopulation; safety was evaluated throughout.
resultsIn the overall ligelizumab re-treatment subpopulation, 53.5% and 57.5% of patients treated with ligelizumab 72 mg and 120 mg, respectively, achieved weekly urticaria activity score (UAS7) of ≤ 6 at Week 12. Re-treatment efficacy was demonstrated in both treatment arms, across all secondary endpoints, maintained up to Week 52. Re-treatment efficacy in the overall trial population showed similar trends to those in the re-treatment subpopulation. The safety profile of ligelizumab showed no new or unexpected safety signals compared with the known safety profile of ligelizumab.
conclusionLong-term and re-treatment with ligelizumab was well tolerated and efficacious in patients with CSU, aligning with the short-term outcomes observed in the Phase 3 PEARL studies.
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