Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LOU064 Arm 1 · 1 trial · 1 indication
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 ...
LOU064 Arm 1 is an investigational small molecule being studied for the treatment of Chronic Spontaneous Urticaria (CSU) in patients whose condition is inadequately controlled by H1-antihistamines. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
LOU064 Arm 1 is a small molecule developed by Novartis AG. The specific molecular target for LOU064 Arm 1 has not been disclosed in the available clinical trial information. The drug is being evaluated for its efficacy and safety in patients with Chronic Spontaneous Urticaria.
LOU064 Arm 1 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is currently in Phase 2 clinical trials for the treatment of Chronic Spontaneous Urticaria.
LOU064 Arm 1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for its efficacy and safety in patients with Chronic Spontaneous Urticaria inadequately controlled by H1-antihistamines.
LOU064 Arm 1 has been studied in one completed Phase 2 clinical trial with the identifier NCT03926611. This was a dose-finding study evaluating the efficacy and safety of LOU064 in patients with Chronic Spontaneous Urticaria inadequately controlled by H1-antihistamines. The trial enrolled 311 participants across multiple countries.
LOU064 Arm 1 is a specific treatment arm within the clinical trial for LOU064, which is the investigational drug being developed by Novartis AG. The trial NCT03926611 evaluated different doses of LOU064, and Arm 1 refers to one of those dose groups in the study.