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: 22 Oct 2024
Price :
$35
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At a glance
- Drugs Roflumilast (Primary)
- Indications Plaque psoriasis
- Focus Adverse reactions; Registrational
- Sponsors Arcutis Biotherapeutics
- 18 Oct 2024 According to an Arcutis Biotherapeutics media release, the company has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older.
- 09 Jul 2024 According to an Arcutis Biotherapeutics media release, company has been in communication with the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) for adults and children down to the age of 6. The FDA has indicated that they are working to finalize the action letter and have not indicated they would extend the PDUFA goal date of July 7, 2024
- 14 May 2024 According to an Arcutis Biotherapeutics media release, company announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older, based on the positive results of INTEGUMENT-1, INTEGUMENT-2, INTEGUMENT-PED, NCT03764475 & NCT04279119 studies.