Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ARQ-252 cream 0.3%, ARQ-252 0.3%
ARQ-252 · 1 trial · 1 indication
The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research.
The number of Cohort 1 participants with AEs coded as application site events is reported.
The number of Cohort 1 participants with an SAE is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health.
The number of Cohort 1 participants with a significant change in hematology is reported.
The number of Cohort 1 participants with a significant change in chemistry is reported.
The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented.
| Arm | Type | Description |
|---|---|---|
| ARQ-252 cream 0.3% QD (once daily) | ACTIVE_COMPARATOR | Active Comparator |
| ARQ-252 cream 0.3% BID (twice daily) | ACTIVE_COMPARATOR | Active Comparator |
| ARQ-252 cream 0.1% QD (once daily) | ACTIVE_COMPARATOR | Active Comparator |
| Vehicle cream BID (twice daily) | PLACEBO_COMPARATOR | Placebo Comparator |
| Vehicle cream QD (once daily) | PLACEBO_COMPARATOR | Placebo Comparator |
| Name | Type | Description |
|---|---|---|
| ARQ-252 cream 0.3% | DRUG | ARQ-252 cream 0.3% |
| ARQ-252 cream 0.1% | DRUG | ARQ-252 cream 0.1% |
| ARQ-252 Vehicle Cream | DRUG | ARQ-252 Vehicle Cream |
Inclusion Criteria * Participants legally competent to sign and give informed consent. * Males and females 18 years of age and older (inclusive) at the time of consent. * Clinical diagnosis of chronic hand eczema, defined as hand eczema persistent for more than 3 months, or returned twice or more w...