UAS7 score change (LS mean Change) from baseline at Week 4 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS)

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement.

Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.

UAS7 score change (LS mean Change) from baseline at Week 12 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS)

Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.

UAS7=0 and UAS7<=6 response rate over time by treatment group (non-responder imputation) The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates more severe disease. A negative change score (week 4 score minus Baseline score) indicates improvement.

Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.

The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reports the occurrence of angioedema ("opening question") with "no", AAS score for this day is 0. If "yes" is the answer to the opening question, the subject will continue to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. The AAS7 is a weekly AAS score (AAS7). Minimum and maximum possible AAS7 scores are 0-105. Higher score means more severe disease.

Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.

Percentage of subjects with DLQI 0/1 response by treatment group and visit (non-responder imputation)

The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.

Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.

Summary of DLQI score and change from baseline

The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL).

FAS

Assessment of the area under the blood concentration-time curve (AUC) up to four hours following oral administration at Week 4 and Week 12 .

Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.

Assessment of the observed maximum blood concentration (Cmax) of LOU064 following drug administration at Week 4 and Week 12 .

FAS

Assessment of the time to reach the maximum concentration (Tmax) of LOU064 following drug administration at Weeks 4 and 12

Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.