NCT05368285Phase 2Completed

A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-28Actual

Enrollment · participants208Actual

Source updated2025-03-26Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Chronic Spontaneous Urticaria

Treatments or interventions studied

barzolvolimabBiologicalAlso known as CDX-0159
Matching PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score); description: Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42. Itch severity score (ISS) is on a scale of 0 - 3. 0 = None 1. = mild (present, but not annoying or troublesome) 2. = moderate (troublesome, but does not interfere with normal daily activity or sleep) 3. = intense (severe itch, which is sufficiently troublesome to interfere with normal daily activity or sleep) Hives severity score (HSS) is on a scale of 0 - 3. 0 = None 1. = less than 20 hives 2. = between 20 and 50 hives 3. = greater than 50 hives; timeFrame: From baseline to Day 85 (Week 12)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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