Trial Profile
A Phase 2, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects With Chronic Plaque Psoriasis Who Have Completed Preceding Study ARQ-151-201 Phase 2 Randomized Controlled Trial (Cohort 1) and Non-ARQ-151-201 Subjects (Cohort 2)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 05 Sep 2022
Price :
$35
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At a glance
- Drugs Roflumilast (Primary)
- Indications Plaque psoriasis
- Focus Adverse reactions; Registrational
- Sponsors Arcutis Biotherapeutics
- 22 Dec 2021 According to an Arcutis Biotherapeutics media release, the U.S. Food and Drug Administration's (FDA) has accepted new drug application (NDA) for roflumilast cream for the treatment of psoriasis in adults and adolescents for review and assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022. This NDA submission is supported by DERMIS 1, DERMIS 2 and a long-term Phase 2b open label study.
- 17 Mar 2021 According to an Arcutis Biotherapeutics media release, data from this study will be presented at the Innovations in Dermatology: Virtual Spring Conference 2021.
- 16 Feb 2021 Status changed from active, no longer recruiting to completed.