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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06927999 | An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria | PHASE2 | RECRUITING | 42 | — | — | Jul 9, 2025 | Jun 1, 2026 | Oct 2, 2025 | 3 | United States, Germany |
Change in itch and hive scores (Uniform Assessment System) \[UAS\] as compared to placebo at each timepoint on exacerbation days
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device. |
| 0.5 mg | ACTIVE_COMPARATOR | 0.5 mg epinephrine per spray |
| 1 mg | ACTIVE_COMPARATOR | 1 mg epinephrine per spray |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo solution nasal spray containing no active drug |
| 0.5 mg epinephrine | DRUG | 0.5 mg epinephrine per spray |
| 1 mg epinephrine | DRUG | 1 mg epinephrine per spray |
Inclusion Criteria: * Is a male or female between the ages of 18 and 65 years, inclusive. * Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month cons...