SYFe6a477970591448eb90e4e1e85b83e2eRegistry ID: 2024-512386-14-00|UnknownPhase 2Results
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interventional
N/A
1 country
4
To assess the role of a complement Factor D inhibitor, Danicopan, by comparing the change in Urticaria Activity Score UAS7 from baseline (week 1, V1) to the end of the open label treatment phase (week 17, V5) in adult CSU patients exhibiting low total IgE (≤40 kU/l) and in patients with high total IgE levels (>40 kU/l).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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July 31, 2024
Actual (reported)The change in baseline to week 17 in UAS7 for patients exhibiting low total IgE (≤40 kU/L) and patients with high total IgE levels (>40 kU/L).
Disease control: Urticaria Control Test (UCT) score and change to baseline; Angioedema Activity Score (AAS), score and change to baseline, percentage of patients with a positive UCT and AAS, respectively
Disease-specific quality of life: Dermatological Quality of Life Index, (DLQI), score and change to baseline; Chronic Urticaria Quality of Life Questionnaire ( CU-Q2oL), score and change to baseline; Angioedema Quality of Life Questionnaire (AE-QoL), score and change to baseline)
Responder rates regarding UAS7 and UCT (none-, partial-, complete response)
Rescue medication use (H1-AH, oral glucocorticoids) (substance and/or substance class)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
DANICOPAN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
DANICOPAN
Named ingredient: danicopan
View registry recordUniversitaetsklinikum Muenster AöR
Muenster, 48149, Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, 12203, Germany
Philipps-Universitaet Marburg
Marburg, 35043, Germany
Dr. Isabel Dittmann
First Submitted
July 31, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, 55131, Germany