---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-22-032097"
form_type: "8-K"
ticker: "ARQT"
cik: "0001787306"
company_name: "Arcutis Biotherapeutics, Inc."
filed_at: "2022-12-16T23:59:59+00:00"
generated_at: "2026-06-21T03:29:52.928375+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Arcutis reports positive Phase 3 results for roflumilast cream 0.15% in atopic dermatitis

## Summary
- INTEGUMENT-1: 32.0% of roflumilast patients achieved IGA success vs 15.2% vehicle (p<0.0001); INTEGUMENT-2: 28.9% vs 12.0% (p<0.0001).
- Key secondary endpoints met: EASI-75 (43.2% vs 22% in INTEGUMENT-1) and WI-NRS itch reduction (33.6% vs 20.7% in INTEGUMENT-1) at week 4.
- Roflumilast cream was well-tolerated with low TEAEs; discontinuation rates low (<2%) in both trials.
- Total 1,337 subjects enrolled across both trials (654 in INTEGUMENT-1, 683 in INTEGUMENT-2); completed study rates ~93% and 90%.
- Company posted updated corporate presentation with trial details; results support potential NDA submission.

## SEC filing metadata
- accession: 0001628280-22-032097
- form_type: 8-K
- ticker: ARQT
- cik: 0001787306
- company_name: Arcutis Biotherapeutics, Inc.
- filed_at: 2022-12-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1787306/000162828022032097/0001628280-22-032097-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1787306/000162828022032097/arqt-20221212.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-22-032097
- JSON: https://secwatch.observer/filing/0001628280-22-032097.json
- Plain text: https://secwatch.observer/filing/0001628280-22-032097.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.