Clinical trials

Explore our ongoing and completed clinical trials below. 

MOA
Disease state
Investigational therapy
Phase
Status
Clinical trial Phase MOA Disease state Investigational therapy Associated publications

Topical roflumilast cream (ARQ-151) phase 3 atopic dermatitis study (INTEGUMENT-2)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Atopic dermatitis Investigational therapy: Roflumilast cream (ARQ-151) 0.15% Associated publications: Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials

Topical roflumilast cream (ARQ-151) phase 3 atopic dermatitis study (INTEGUMENT-1)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Atopic dermatitis Investigational therapy: Roflumilast cream (ARQ-151) 0.15% Associated publications: Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials

Topical roflumilast cream (ARQ-151) phase 2b plaque psoriasis study

Completed

Phase: 2b MOA: PDE4 inhibitor Disease state: Plaque psoriasis Investigational therapy: Roflumilast cream (ARQ-151) 0.3% Associated publications: Trial of Roflumilast Cream for Chronic Plaque Psoriasis

Topical roflumilast cream (ARQ-151) phase 2 plaque psoriasis open-label long-term safety study

Completed

Phase: 2 MOA: PDE4 inhibitor Disease state: Plaque psoriasis Investigational therapy: Roflumilast cream (ARQ-151) 0.3% Associated publications: Long-Term Safety and Effectiveness Of Roflumilast Cream 0.3% In Adults With Chronic Plaque Psoriasis: A 52-Week, Phase 2, Open-Label Trial

Topical roflumilast cream (ARQ-151) phase 1/2a plaque psoriasis study

Completed

Phase: 1/2a MOA: PDE4 inhibitor Disease state: Plaque psoriasis Investigational therapy: Roflumilast cream (ARQ-151) 0.3% Associated publications: Roflumilast Cream for Plaque Psoriasis: Results From a Phase 1/2a Randomized, Controlled Study

Topical roflumilast cream (ARQ-151) open-label extension trial in atopic dermatitis (INTEGUMENT-OLE)

Completed

Phase: 3 MOA: PDE4 inhibitor Disease state: Atopic dermatitis Investigational therapy: Roflumilast cream (ARQ-151) 0.15% Associated publications: Long-Term Safety and Efficacy with Roflumilast Cream 0.15% in Patients Aged ≥6 Years with Atopic Dermatitis: A Phase 3 Open-Label Extension Trial
Arcutis Biotherapeutics logo

This website is intended for US healthcare professionals only. There may be information included that pertains to an investigational therapy or formulation that has not yet been approved for use in your country. The safety and efficacy of investigational therapies and/or formulations and/or uses have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated. This information is as of 10/2025 to the best of the Company’s knowledge and Arcutis assumes no obligation to update this information.

© 2025 Arcutis Biotherapeutics, Inc. All rights reserved. MED0001 v3.0 10/2025.