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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05496465 | Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares | PHASE2 | COMPLETED | 21 | — | — | Jul 28, 2022 | Feb 29, 2024 | Apr 7, 2026 | 2 | United States |
Assess time to effect and duration of effect on acute flares associated with urticaria based on a patient reported pruritus/hive score, from 0 (none) to 3 (severe) for itch and hive using Uniform Assessment System (UAS) as below: Severity Score Amount of Itch Itch Severity 0 None None 1. Mild Easily tolerated 2. Moderate Bothersome but tolerable 3. Intense Difficult to tolerate Hive Severity Score Number of Hives 0 None 1. 1-6 2. 7-12 3. \>12
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | 1 mg ARS-1 IN: placebo: 2 mg ARS-1 IN |
| Sequence 2 | EXPERIMENTAL | 2 mg ARS-1 IN: placebo: 1 mg ARS-1 |
| Name | Type | Description |
|---|---|---|
| ARS-1 | DRUG | A single treatment of ARS-1 1mg, 2 mg or placebo |
Inclusion Criteria: * 1\. Male or female subject between the ages of 18 and 65 years. * 2\. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment. * 3\. Body weight more than 30 kg and body mass index between 18 and 34 kg/m². * 4\. Has n...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 10 | PHASE3 | LOU064, Remibrutinib, Omalizumab, Dupilumab |
| Celldex Therapeutics, Inc. | CLDX | 4 | PHASE3 | barzolvolimab, Barzolvolimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
| ARS Pharmaceuticals, Inc. | SPRY | 1 | PHASE2 | epinephrine |
| Jasper Therapeutics, Inc. | JSPR | 2 | PHASE2 | Briquilimab |
| Blueprint Medicines Corporation | BPMC | 1 | PHASE2 | BLU-808 |
| Azitra Inc. | AZTR | 1 | PHASE1 | ATR04-484, Vehicle |
| BeOne Medicines Ltd. Sponsored ADR | ONC | 1 | PHASE1 | BGB-16673 |
| Sanofi SA Sponsored ADR | SNY | 1 | — | Dupilumab |
| Enanta Pharmaceuticals, Inc. | ENTA | 1 | PHASE1 | EDP-978 |