Celltrion to Present New Analyses of OMLYCLO® (omalizumab-igec) in Chronic Spontaneous Urticaria at ACAAI 2026

Detailed summary

Post hoc analyses of the Phase 3 study of CT-P39 (omalizumab-igec) found that improvements in quality of life, as assessed by the Dermatology Life Quality Index, emerged earlier…

JERSEY CITY, N.J., Nov. 12, 2026 /PRNewswire/ -- Celltrion USA, Inc. today announced that three post hoc analyses from the Phase 3 study of OMLYCLO® (omalizumab-igec; CT-P39) in chronic spontaneous urticaria (CSU) will be presented as posters on Nov. 14 and 15 at the American College of Allergy, Asthma and Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix, Arizona.

One analysis examines the relationship between CSU disease activity and quality of life (QoL) during omalizumab treatment, and a second evaluates outcomes according to baseline itch severity. A separate post hoc subgroup analysis evaluates the pharmacokinetics and target engagement of CT-P39 and reference omalizumab in patients with CSU who had physician-reported asthma at baseline.[1]-[3]

The presentations come after last month's U.S. launch of OMLYCLO, the first and only FDA-approved interchangeable biosimilar to XOLAIR® (omalizumab).

"Chronic spontaneous urticaria can affect far more than the skin, and allergists increasingly recognize that CSU can have systemic features and frequent comorbidities. The impact on quality of life can be substantial, with approximately 40% of patients with CSU scoring greater than 10 on the Dermatology Life Quality Index, [4]" said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "The analyses being presented at ACAAI add to the body of evidence supporting OMLYCLO and reflect Celltrion's commitment to advancing clinically meaningful research for the allergy and immunology community."

Presentation DetailsAll three analyses will be presented during ePoster Meet the Author sessions at the Phoenix Convention Center.Disease Activity and Quality of Life During Omalizumab TreatmentDate: Saturday, Nov. 14, from 12:30-12:45 p.m. MTAbstract Title: "Association Between Disease Activity and Quality of Life During Omalizumab Treatment in Chronic Spontaneous Urticaria"Session: ePoster – Meet the AuthorePoster: R100 (Monitor 15)

This post hoc…

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