Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARQ-154 · 1 trial · 1 indication
The number of participants with treatment-emergent AEs 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. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
The number of participants with treatment-emergent SAEs 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. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
| Arm | Type | Description |
|---|---|---|
| Long-term safety of ARQ-154 | EXPERIMENTAL | Open-label, Long-term Safety of ARQ-154 |
| Name | Type | Description |
|---|---|---|
| ARQ-154 | DRUG | ARQ-154 foam 0.3% applied once daily for 52 weeks |
Inclusion Criteria: 1. Participants legally competent to sign and give informed consent or (for adolescents) assent. 2. Males and females ages 9 years and older (inclusive) at the time of consent. 3. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study vi...
ARQ-154 is an investigational small molecule being developed for the treatment of seborrheic dermatitis, a chronic inflammatory skin condition. It is formulated as a foam for topical application. The drug is currently in clinical development and has not been approved by regulatory authorities.
ARQ-154 is being developed by Arcutis Biotherapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ARQT. The company is focused on developing innovative dermatology treatments.
ARQ-154 is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 2 trial evaluating the long-term safety of ARQ-154 foam in subjects with seborrheic dermatitis has been completed.
ARQ-154 has one completed clinical trial, NCT04445987, titled 'Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis.' This Phase 2 study enrolled 408 participants in the United States and included individuals aged 9 years and older.
ARQ-154 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for seborrheic dermatitis. The completed Phase 2 trial focused on long-term safety, and further studies would be needed to support a regulatory submission.