Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03926611 | This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines | PHASE2 | COMPLETED | 311 | — | — | Jun 6, 2019 | Apr 15, 2021 | Apr 29, 2022 | 82 | United States, Argentina +15 |
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.
| Arm | Type | Description |
|---|---|---|
| LOU064 Arm 1 | EXPERIMENTAL | 10 mg LOU064 qd capsule once daily |
| LOU064 Arm 2 | EXPERIMENTAL | 35 mg capsule qd LOU064 once daily |
| LOU064 Arm 3 | EXPERIMENTAL | 100 mg capsule qd LOU064 once daily |
| LOU064 Arm 4 | EXPERIMENTAL | 10 mg capsule LOU064 bid |
| LOU064 Arm 5 | EXPERIMENTAL | 25 mg capsule LOU064 bid |
| LOU064 Arm 6 | EXPERIMENTAL | 100 mg capsule LOU064 bid |
| Placebo Arm | PLACEBO_COMPARATOR | Participants took matching placebo twice daily |
| Name | Type | Description |
|---|---|---|
| LOU064 Arm 1 | DRUG | 10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85 |
| LOU064 Arm 2 | DRUG | 35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85 |
| LOU064 Arm 3 | DRUG | 100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85 |
| LOU064 Arm 4 | DRUG | 10mg bid of LOU064 orally, twice daily from Day 1 to 85 |
| LOU064 Arm 5 | DRUG | 25 mg bid of LOU064 orally, twice daily from Day 1 to 85 |
| LOU064 Arm 6 | DRUG | 100 mg bid of LOU064 orally, twice daily from Day 1 to 85 |
| Placebo arm | DRUG | Matching placebo, orally, twice daily from Day 1 to 85 |
Inclusion Criteria: * Male and female subjects aged ≥18 years of age * CSU diagnosis for ≥ 6 months prior to screening * Presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time ...